Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

Cipla Ltd
HQ: Mumbai, India • Ticker: CIPLA • Stock exchange: NSE • Nr. of employees: 26,615

CO M PANY SU M MARY
Cipla has a broad portfolio of off-patent medicines covering a diversity of therapeutic areas, and manufactures products at 47 sites across the world. The company’s
access efforts encompass its corporate social responsibility activities and its ‘’Cipla
Global Access” business, through which it collaborates with international organisations and procurement agencies to supply essential medicines to low- and middleincome countries (LMICs). Cipla registers its products across a variety of LMICs,
including low-income countries. Cipla expands access to its products by engaging incompetitive tenders by governments and hospitals, while adhering to local pricing
policies and competitor-based pricing strategies in the private sector. Cipla hassigned licensing agreements that allow the company to market generic products in
LMICs to treat diseases such as HIV and COVID-19. Cipla implements forecastingmechanisms and promotes supplier diversity, among other strategies, to ensure
continuous product supply and mitigate shortages. Cipla reports one example ofan adaptive R&D project, consisting of a paediatric fixed-dose combination of four
antiretrovirals, which can simplify dosage and improve treatment adherence.

Main therapeutic areas
Cardiovascular diseases; infectious
diseases; metabolic disorders;
oncology; respiratory diseases;
dermatology; gastrointestinal;
urology; central nervous system.
Business segments
New Ventures; Pharmaceuticals.
Product categories
Active pharmaceutical ingredients(APIs); biosimilars; consumer healthproducts; generic medicines.
Sales presence*
Cipla reports sales in 26 countries inscope.

OPPO RTU N ITI ES FOR CI PL A
Expand efforts to ensure productoptions are ineffective or lacking, suchhas registered the product; cervicalavailability in sub-Saharan Africa.

as paediatric formulations.

cancer is prevalent; and the majority of

Cipla has made a commitment topatients pay out-of-pocket.

improve product availability by

Expand registration and affordability

strengthening its local manufacturingof essential cancer products.

Expand engagement in voluntary

presence, incorporating this commit-

Cipla can expand access to essential

licensing agreements.

ment into its business strategy for thecancer products in its portfolio by

As a sublicensee in various licensing

SAGA region.** Cipla can deliver on thispursuing broader registration filings inagreements, Cipla is following throughcommitment by expanding in-house

LMICs, particularly in high-burden andon its commitments to register in-li-

manufacturing and by engaging in the

low-income countries. For cisplatincensed products in LMICs in scope.

transfer of skills to local manufacturers

and carboplatin, indicated for various

Cipla can build on these efforts by con-to develop and strengthen capacity forcancers including cervical cancer, Cipla

tinuing to register products like dolute-

manufacturing products targeting highcan file for registration in LMICs withgravir in more countries, especiallyburden diseases in the region.

high cervical cancer burdens where it

to reach children and young women

has previously registered other prod-

living with HIV. Having recently signed aContinue to engage in adaptive R&D

ucts in its portfolio including Botswana,

non-exclusive licence for cabotegravir

to develop products that address

Suriname, and Zimbabwe. Moreover,long-acting, used for HIV pre-exposure

R&D priority gaps.

in the countries where these cancer

prophylaxis (PrEP), Cipla can ensure

Cipla has partnered with the Drugs fortreatments are already registered,broad registration in countries with

Neglected Diseases initiative (DNDi)

Cipla can prioritise implementing

high HIV burden, once possible. The

to produce a 4-in-1 fixed-dose com-

access strategies, using approaches

company can also explore engaging in

bination for the treatment of HIV inthat include elements to address

additional voluntary licensing agree-

children. The company can continue

affordability, supply, and local barriers

ments across other therapeutic areas,

to leverage its R&D expertise to adapt

to access. Cipla can apply such strat-

including non-communicable diseases,

products targeting diseases with highegies to expand access to cisplatin inwhen relevant.

burden in LMICs, where treatment

Nepal, which is a country where Cipla*Refers to countries in which sales are
conducted through suppliers, pooled procurement and/or the company sales
offices.

**South Africa, sub-Saharan Africa, andthe countries covered by the Cipla Global
Access business.

Cipla exclusively submitted data for theevaluation of themes EA2, EA3, EA4, RD1
and RD2. All other information was initially sourced from publicly available dataand subsequently fact checked by thecompany.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

CO M PANY PRESE NCE & REVE N U E
Sales and manufacturing presence in countries in scope

Sales presence and at least
one manufacturing site
Sales presence
No sales presence
Countries not in scope

Revenue by business segment*

2022

Revenue by region*

213,513

2023

5,315

219,9940

60,000120,000

180,000

10,548240,000
bn INR

2022

98,2752023

44,314

98,687060,00048,71559,087
120,000

26,33046,40723,351

180,000

240,000
bn INR● India ● Rest of World ● United States ● South Africa● Pharmaceuticals ● New Ventures

PO RTFO LI O & PRODUCTS ANALYSE D
Products in scope from the company’s portfolio

Products selected for assessment

Out of the 102 products in scope of this analysis,** Cipla has 66 products

Of the in-scope products that Cipla has in its portfolio, ten off-patent med-

within its portfolio. Cipla’s portfolio has a strong focus on non-communi-

icines were selected for analysis for the themes EA2 (product registration)

cable diseases (NCDs), as well as communicable diseases (CDs) including

and EA3 (expanding access and pricing strategies).

bacterial infections, HIV and hepatitis B and C.
66 products
These target a range of disease categories, namely NCDs (40), CDs (21),neglected tropical diseases (3) andreproductive, maternal and newborn
conditions (4). Two products fall into
multiple categories.

Product

Indication

Carboplatin

Cancer

Cisplatin

CancerRituximab

CancerTelmisartan

Hypertensive heart disease

Formoterol/budesonide

AsthmaChronic obstructive pulmonary
disease (COPD)

Salbutamol

Product is in Cipla's portfolio
Product is not in Cipla's portfolio*Financial year (FY) 2022 covers April
2021 - March 2022. FY 2023 covers April
2022 – March 2023.

Asthma
COPD**The Generic & Biosimilar Medicines
Programme’s product scope includes
102 off-patent medicines, most of which
are listed on the 22nd World HealthOrganization’s Model List of Essential
Medicines. Essential medicines are thosethat satisfy the priority health care needsof a population.

Metformin

Diabetes mellitus

Nitrofurantoin

Bacterial infection

Abacavir/lamivudine (ABC+3TC)

HIV

Sofosbuvir

Hepatitis C

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

EXPANDING ACCESSE A1 . ACCESS -TO - M E D I CI N E STR ATEGY
Cipla commits to ensuring access to its medicines globally and reports

to identify reliable suppliers and ensure efficient delivery of medicines.

working towards improving their availability and affordability, but does

While the board approves and monitors the company’s CSR activities, Cipla

not present evidence of an overarching access-to-medicine strategy. The

does not report where the highest responsibility lies for ensuring accesscompany’s Corporate Social Responsibility (CSR) division carries out its

to medicine in LMICs. Moreover, the company identifies availability andactivities through the Cipla Foundation, the company’s philanthropy arm,

affordability of its medicines as a high-priority topic in its recent material-and focuses on five key areas: health, education, environmental sustaina-

ity assessment, providing evidence of supplying medicines for affordable

bility, disaster response activities and skillset development. Additionally,

prices. For example, since 2001 it offers a one-dollar-a-day treatment forthrough its “Cipla Global Access” (CGA) business, the company expands

HIV patients in Africa. Although access considerations guide some of theaccess to products, including those targeting HIV, tuberculosis, and malaria,

company’s activities, it does not disclose measurable and time-boundby working with international and donor organisations to supply essen-

objectives for its access-to-medicine commitments, nor specific strategies

tial medicines in LMICs. CGA also collaborates with procurement agencies

to ensure sustainable access and expand patient reach.

E A2 . PRO D U C T R EG I STR ATI O N
Cipla has filed to register or successfully registered at least one prod-

Several of the company’s products have been registered in the AFRO***uct within its entire portfolio in 61 LMICs in scope. This demonstrates theregion and Ukraine through the World Health Organization (WHO)company’s ability to register products with national regulatory authorities

Collaborative Registration Procedure (CRP) for WHO Prequalified prod-(NRAs) in LMICs in scope.

ucts, including products to treat HIV, hepatitis C, malaria, soil-transmitted

Of the products within the scope of the Generic & Biosimilar Medicines

helminthiasis, maternal haemorrhage, and tuberculosis. Examples of such

Programme, ten off-patent medicines were selected for assessment. Cipla

products are fixed-dose antiretroviral combinations abacavir/lamivudine

has filed at least one of these products for registration in a total of 48 out

and dolutegravir/lamivudine/tenofovir disoproxil fumarate to treat HIV,of the 61 LMICs (79%) where it has pre-existing regulatory filings,* showing

along with an emergency contraceptive method, levonorgestrel. Moreover,the company’s capacity to register across a wide geographic area. These

five of the company’s products (outside the product scope of this analysis)ten products have all been registered in at least one country in scope, withhave been recommended for approval by ZaZiBoNa.†

one product registered in a total of 32 countries. For low-income countries,

In April 2021, the company’s subsidiary Cipla Quality Chemical

the company registers the ten products selected for assessment in 14 out

Industries Limited (CiplaQCIL), based in Uganda, was approved to man-of the 15 low-income countries where it has pre-existing regulatory filings.*

ufacture and distribute medicines to the Economic Community of WestThis is significant as in general regulatory filings in these countries are low,

African States and ZaZiBoNa regions in Africa. In March 2023, the com-and significant gaps in access to essential medicines remain.** However,pany announced it would be divesting its stake in CiplaQCIL. The impact ofcarboplatin, rituximab, telmisartan and nitrofurantoin were not regis-

this divestment is unknown, however, Cipla reports that they have reachedtered in any low-income countries. The company engages in mechanisms

mutual agreements with CiplaQCIL for transition and technology support,

designed to facilitate the registration of quality-assured products in LMICs.

ensuring business continuity for the near and medium term.

FIGURE 1 Registration filings of ten products selected for assessment across income categories
This figure shows the number of registrations for the ten off-patent products included in this assessment,
categorised by whether the filing is in a low-, lower-middle or upper-middle income country.
Abacavir/lamivudine (ABC+3TC)

9

Carboplatin

5

Cisplatin2

Formoterol/budesonide

11

1
4

Metformin

2

Nitrofurantoin

1

Rituximab

1

2

1

13
3

Salbutamol

1

4

6

Sofosbuvir

2

Telmisartan

19

7

1
3

0

5

10

15

20

25

30

● Registration filings in low-income countries● Registration filings in lower-middle income countries● Registration filings in upper-middle income countries

Salbutamol and formoterol/budesonide, indicatedfor asthma and COPD, are widely registered in 32
and 18 countries in scope, respectively.

*Refers to all the countries in scope where
the company has previously filed for or
successfully registered any of its products. This includes products that fall outside the scope of the Generic & Biosimilar
Medicines Programme.

35

Number of registration filings**Based on data analysed in the 2022
Access to Medicine Index and the 2021
Antimicrobial Resistance Benchmark.

Rituximab, a monoclonal antibody used
for the treatment ofcertain cancers, suchas non-Hodgkin lymphoma, is only registered in one country
in scope: India.

Nitrofurantoin, anantibacterial medication
used to treat urinary tract
infections, is only registered in one upper-middle income country inscope, South Africa, withno registrations in low-income countries.

Telmisartan, an antihypertensive, is only
registered in three lower-middle income
countries in scope and no low-income
countries.

***AFRO region includes c­ ountries
including but not limited to: Botswana,
Democratic Republic of the Congo, Ghana,
Malawi, Mozambique, Namibia, Nigeria,
Tanzania, Uganda, Zambia and Zimbabwe†ZaZiBoNa process is a work-sharing
initiative amongst national regulatory
authorities (NRAs) in Zambia, Zimbabwe,
Botswana, Namibia, South Africa,
Democratic Republic of Congo, Tanzania,
Malawi and Mozambique.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

EXPANDING ACCESS
E A 3. E XPAN D I N G ACCESS AN D PR I CI N G STR ATEG I ES
Seven out of the ten products selected for assessment are covered byfor their medicines, and it is unclear if the product is affordable for thesean access strategy in the public and/or private market. Cipla submit-

patients. Furthermore, the success of these tender strategies remains

ted examples of access strategies for its products in a range of country

uncertain due to the lack of evidence regarding the number of patients

income classifications, with examples provided from three upper-middle

reached by such initiatives.

income countries, one lower-middle income country and three low-income

Cipla supplies abacavir/lamivudine (ABC + 3TC) in 20 countries, incountries. For the country examples provided, the company primarily par-which its access strategies are primarily focused on the public sector. Of

ticipates in government tenders to facilitate access to its products withinthese, Benin, a low-income country, has been selected as an example forthe public sector. In the private sector, Cipla adheres to local pricing pol-this analysis. In Benin, the company supplies the product via participating

icies and employs competitor-based pricing strategies to determine thein tenders issued by the government or by international agencies, such as

pricing of its products. However, the company only provides evidence of

the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund).

the number of patients reached for one product, and it does not provide

By engaging in supranational procurement, Cipla aims to expand access toevidence of forecasting patient reach for any of the ten products.

affordable, quality-assured products while reducing commercial risks. The

For one of the products, sofosbuvir, indicated for hepatitis C, thecompany supplies products below agency-set ceiling prices, with tendercompany participates in tenders to supply the product in the public sec-

allocation based on factors including competitive pricing, delivery timeline

tor in several countries; this includes Rwanda, which was selected as aand minimum procurement quantities. Cipla submitted patient reach data

specific country example. In Rwanda, the product is fully funded by thefor abacavir/lamivudine (ABC+3TC), using the volume of tablets supplied

government, meaning that individual patients do not have to pay for theiras a metric for number of patients reached. In the period from April 2019

treatment.

to July 2023, the company provided a total of 1.6 million tablets in Benin.

For three of the ten products assessed (metformin, nitrofurantoin andsalbutamol), Cipla reports implementing access strategies in both theAcross the 20 countries it supplies, the company supplied 180 million tablets between January 2020 and April 2023.

public and private sectors within South Africa. In the public sector, theFor two of the ten products assessed, formoterol/budesonide and tel-company supplies the three products via government tenders which aremisartan, the examples of access strategies submitted – in Zambia andawarded based on the lowest pricing, and the entire cost is government

Madagascar, respectively – only cover patients in the private sector. In

funded. In the private sector, the company implements competitor-based

these countries, the price of each product is set based on the competitor

pricing strategies. The resulting price is then submitted to the Department

landscape, and patients have to pay out of pocket. Furthermore, the com-of Health, which approves the final price (the single exit price) at which thepany did not provide evidence of patient reach, therefore it is unclear if thecompany sells the products. The product’s price is covered by private insur-

company has ensured access to the two products in the countries where it

ance, either fully or partially, depending on the plans to which the patient

operates.

is subscribed. Patients not part of a private scheme will pay out-of-pocket

FIGURE 2 How many products are covered by an access strategy?
For each of the ten products selected for assessment, Cipla was requested to provide one example of acountry-specific access strategy covering that product. The company was asked to include examples
from a minimum of three low-income countries (LICs) and three lower-middle income countries(LMICs). Further examples could come from upper-middle income countries (UMICs). The types ofaccess strategies the company utilises for each product are outlined in this figure. Where details on
country-specific access strategies were not shared, the company was not assessed.
PrivateInternational
Nonproprietary

Evidence of

Additional ­Public market

marketEvidence

forecasting

initiatives toaccess/pricing

access/pricing

of patientpatient

improve ­affordability

Name (INN)Country

strategies

strategies

reach

reach

and availability*

Abacavir/lamivudine (ABC+3TC)

Benin (LIC)●

Carboplatin

No country-specific●access strategy
Cisplatin

No country-specificaccess strategy

Formoterol/budesonide

Madagascar (LIC)

MetforminSouth Africa (UMIC)●●●

Nitrofurantoin

South Africa (UMIC)●●

Rituximab

No country-specific●access strategy
SalbutamolSouth Africa (UMIC)●

Sofosbuvir

Rwanda (LIC)●

Telmisartan

Zambia (LMIC)●

For three assessed products, carboplatin, cisplatin, rituximab,
Cipla did not provide evidence of expanding access within
LMICs in scope.

*For example: donations, public-private partnerships, or patient assistanceprogrammes.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

EXPANDING ACCESSE A4 . E N GAG I N G I N LI CE N S I N G AC TIVITI ES
Five in-licensed products were selected for assessment: dolutegravir(adult) and lopinavir/ritonavir (paediatric), indicated for HIV; dulaglutide,
indicated for type 2 diabetes; and molnupiravir and remdesivir, indicatedfor COVID-19.
Cipla was granted a non-exclusive voluntary licensing agreement(NEVL) for dolutegravir (adult) facilitated through the Medicines Patent
Pool (MPP). The company has registered this product in 22 countries inscope, including Mozambique, Zambia and Zimbabwe, three of the ten
countries with the highest disease burden for HIV. The company supplied
approximately 25 million tablets in countries in scope and has supplied over
one billion doses of the fixed dose combination (FDC) tenofovir, lamivudine, and dolutegravir globally.
The company has an exclusive licensing agreement with Eli Lilly to market and distribute Trulicity® (dulaglutide), a treatment for type 2 diabetes,in India.* Eli Lilly is responsible for manufacturing the product and is theprimary marketing authorisation holder, with Cipla being the second. It
was reported that 142,800 units of Trulicity® were sold from June 2022 toJune 2023.

Examples of Cipla’s licensing agreements
In March 2023, Cipla entered into a NEVL with ViiV Healthcare,facilitated by the MPP, for cabotegravir (CAB) long acting (LA) for
HIV pre-exposure prophylaxis (PrEP) which will be manufactured inIndia and South Africa. An extended-release formulation of CAB, thefirst long-acting injectable for HIV PrEP, was approved in 2021. Thisextended dosing regimen, administered through a single injection every
two months, offers a convenient alternative to daily oral medication,
by reducing dosing frequency and improving treatment adherence andadministration challenges in LMICs. The agreement allows three genericmanufacturers to develop, manufacture, and supply generic versions in
87 countries in scope, prior to patent expiry of the original drug in 2031.
Cipla and ViiV Healthcare also signed an MPP licence for dolutegravir(paediatric), the terms of which also allows licensees to combine dolutegravir with other antiretrovirals to develop fixed dose combinations.
In December 2022, Cipla received approval from the Global Fund forabacavir, lamivudine and dolutegravir FDC for use in children.

FIGURE 3 Registration filings of Cipla’s in-licensed products**
This figure shows the number of LMICs in scope where Cipla has filed for registration or registered fourin-licensed products out of the five selected for assessment, compared to the total number of countries
covered by the licensing agreement.*
Remdesivir

2

88

Lopinavir/ritonavir (paediatric) 1

92

Molnupiravir

93

2

Dolutegravir (adult)

22

0
For lopinavir/ritonavir(paediatric), a NEVL
was facilitated throughthe MPP. Cipla reportsthat it has registered
this product in one
country, South Africa.

20

70

40

60

80

100

Countries● Countries covered by the licence where thecompany has filed for registration● Countries covered by the licence where thecompany has not filed for registration

Cipla was granted NEVLs for two
COVID-19 products, molnupiravir andremdesivir. Several factors including
clinical guidelines and widespreadrollout of COVID-19 vaccinations
reduced demand for these products
and as a result both products were only
registered in Thailand and Indonesia.
However, the company retains the rightto register and supply these products,
should the need arise.

E A 5. I M PROVI N G PRO D U C T AVAI L AB I LIT Y
Cipla’s manufacturing network consists of 47 sites globally, with several

branded fixed-dose antidiabetic medication, and it has entered the market

sites located in LMICs in scope, including China, India, Morocco and Southin Ghana, following recent regulatory approvals.

Africa. As part of its three-year (2020-2023) business strategy within its

In 2014, Cipla acquired a stake in Quality Chemical Industries Limited

SAGA*** region, covering countries across the African continent, Cipla aims

(QCIL) in Uganda, which has served as a hub to supply antiretrovirals

to improve product availability by strengthening its local manufacturing(ARVs), antimalarials and hepatitis B products in the country and thepresence through expansions and optimisations of its existing sites andregion. However, in March 2023 it was announced that Cipla will divest

by developing new sites. As part of this strategy, it also states that it aims

its stake in QCIL, with the site ceasing to be a subsidiary of the com-

to maintain its focus in sub-Saharan Africa by growing and launching new

pany. Cipla and QCIL have established transition agreements for shortproducts, including cardiovascular and respiratory therapies. For 2023-

and medium-term business continuity. The extent of Cipla’s contin-

2024, the company reports that it aims to strengthen its private market

ued manufacturing and supply presence in the region remains uncertain.

position in the region and is planning new product launches targeting cardi-

Furthermore, Cipla commissioned a new manufacturing site during 2021 -ovascular diseases and diabetes.

2022 in Qidong, China to manufacture respiratory products for emerging

Cipla reports market growth in certain African countries. For instance,
in South Africa, the growth appears to be driven by products in the private

markets.† The company recently reported growth in countries including
Nepal and Sri Lanka.

market, including those targeting neurological and respiratory diseases.

Cipla does not disclose being involved in technology transfers or part-

Cipla has also reported a strong presence in Kenya, where it markets anerships to develop or enhance local manufacturing in countries in scope.

*Cipla’s Trulicity® licence with Eli Lilly was
excluded from this analysis as Cipla is not
the primary market authorisation holder
and therefore not responsible for registering the product.

***South Africa, sub-Saharan Africa andCipla Global Access.

**Products may be available through othermechanisms without having been filed forregistration by the company.

†Cipla’s definition of emerging markets
covers the Latin American, North African,
Middle Eastern, South Asian (excluding
India) and the Pacific regions.

22Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

SUPPLY & QUALITY
SQ1 . D E MAN D PL AN N I N G AN D DATA S HAR I N GCipla reports having an internal system for forecasting and demand

Planning and Detailed Scheduling system and its Integrated Businessplanning. This includes both a 12-month rolling forecast process, and a

Planning system, helping the company improve its capacity utilisation.

long-term demand planning process that looks five years ahead to assess

While Cipla company reports communicating with critical vendors tofuture need, to evaluate, and to build capabilities to meet demand. The

ensure a continuous supply of its products, the company did not provide

company holds monthly planning meetings with its sales and supply chain

information about data sharing initiatives with external stakeholders suchteams to review the latest demand and supply updates and to take cor-

as government agencies and wholesalers to align supply and demand.

rective actions. Cipla also reports it has integrated both its Production

SQ2 . D E LIVE RY PE R FO R MAN CE
Cipla reports having a vendor engagement programme to support its ven-

18 vendors in improving their OTIF scores. For FY 2023-2024, it has set adors by assisting them in improving their performance, such as their On

compliance target of 85%. However, the company does not report how it

Time in Full (OTIF) scores. The programme seeks to reduce the risk of ven-meets its supply commitments to national and international procurement

dor disqualification and resultant supply chain disruption. The company

agencies. Cipla reports implementing tools for improving its supply chain

reports that it uses OTIF to monitor internal delivery performance. During

responsiveness, such as a digital platform providing users with updates on

the fiscal year (FY) 2022-2023, it achieved 90% compliance for 21 vendors

purchase order statuses, and a mobile application providing access to sup-(as compared to a target of 85% for 20 vendors). In addition, it supported

ply chain Key Performance Indicators.

SQ3. STO CKO UTS AN D S H O RTAG ES M ITI GATI O N
Cipla has implemented multiple strategies to promote a continuous supply

also aims to reduce costs and promote local manufacturing. It also reports

of its products and mitigate the risk of shortages and stockouts.

implementing vendor reviews as a way to address logistical challenges and

The company reports maintaining sufficient buffer stock and inventory

ensure uninterrupted raw material supply. In addition, for 2022-2023, theof critical components. Cipla reports using stock norms ranging from twocompany reports having spent 62% of its total procurement budget on

to 12 months in India, with some exceptions made for certain components.

sourcing locally to the country of operation, including in India, South Africa

It also audits its stocks on a regular basis and secures quantities of active

and Uganda.

pharmaceutical ingredients (APIs) in advance. To mitigate shortages, theCipla produces APIs both for its own use and for supplying customers incompany applies a rolling 12-month open purchase order pipeline for key

over 50 countries. It reports having supplied over 110 distinct APIs to third

components. It also reports monitoring the risk of shortages and stockouts

parties during 2022-2023, which include ingredients for gastrointestinal,

on a monthly basis and planning corrective or preventive actions accord-

central nervous system and respiratory therapies. It also states it will con-

ingly. However, the company does not disclose the specific countries intinue focusing on critical and high-demand APIs to ensure uninterrupted

which it holds stocks for regional supply, or where it has taken steps to

supplies to key customers. The company has transitioned its supply chain

decentralise stocks of critical components.

management strategy from a pull to a push strategy to manufacturing

Cipla reports having diversified its sources for critical APIs, interme-

products in advance to reduce lead times and maintain sufficient stocks.

diates and key starting materials to reduce single source dependency. In

Cipla’s additional approaches to prevent shortages and stockouts

line with this, the company has taken steps to de-risk its upstream sup-include placing advance orders with vendors and transporters, entering

ply by implementing an alternative vendor development strategy, whichrate contracts with sea liners and booking cargo slots in advance.

FIGURE 4 What steps is Cipla taking to mitigate stockouts and shortages?
This table shows the approaches the company reports taking to ensure the uninterrupted supply of its
products.
Approaches to mitigate stockouts and shortages
Strategies to maintain sufficient stock for critical components, including buffer and safety stocks●

Conducting regular audits of its stock●

Disclosure of the frequency of stock auditing
Holding regional stocks and/or making efforts to decentralise stocks of critical components
Strategies to promote third-party supplier diversity, such as establishing alternative sources of APIs,
excipients and packaging materials
Implementation of sourcing strategies, such as procuring from local suppliers in LMICs
Evidence of a policy or approach for scaling up the production of APIs to quickly adapt to meetsurges in demand, when applicable
Other initiatives to fulfil emergency orders and/or surges in demand

Cipla states that they hold regional
stocks in LMICs, however, it does
not disclose specific strategies toexpand or decentralise its stocks.

●
●
●
●

Cipla has implemented an alternative vendor development strategy,
which aims to de-risk its upstream
supply, reduce costs and promotelocal manufacturing.

●

Cipla reports engaging in local
sourcing in India, South Africa andUganda.

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Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

SUPPLY & QUALITY
SQ4 . MAN U FAC TU R I N G Q UALIT Y A SSU R E D PRO D U C TS
Cipla reports that its 47 manufacturing facilities are current Good

ment system and a software platform, ‘TrackWise’, at its sites in India andManufacturing Practices (cGMP) compliant, in alignment with internationaloverseas to digitise and automate its QMS data. This platform aims toregulatory authorities. It also reports that its sites have been inspected bystreamline operations and improve risk management, including manage-

Stringent Regulatory Authorities (SRAs) including MHRA (UK), EMA (EU),ment of Corrective Action and Preventive Action (CAPA) processes. This

FDA (US), TGA (Australia) and by National Regulatory Authorities (NRAs)

module of the QMS has already been implemented in several countries inoperating at maturity level 3 (ML3) such as EDA (Egypt), and CDSCO

scope, including South Africa and Uganda.

(India). However, there is no publicly available information on which of

Cipla evaluates its vendors, suppliers, and contract manufacturing

the 47 manufacturing sites have approval from at least one SRA and/organisations on quality parameters to ensure compliance with cGMP

or NRA operating at ML3/4.* The company does participate in the WHO

requirements. The company has a supplier code of conduct to follow andPrequalification programme and is subject to inspections by WHO.

performs annual supplier audits and event-based supplier engagement

Cipla has implemented various initiatives to standardise quality man-on compliance and QMS. To address gaps in cGMP practices, regulatory

agement across its manufacturing sites. For instance, the company hascompliance, and audit readiness, the company has a vendor engagement

rolled out the Quality Metric Program (QMP), a compliance monitoring

programme and a ‘Supplier Scorecard’, which is a performance monitor-

tool, in additional regions in Africa and emerging markets. QMP, is a govern-

ing tool that evaluates supplier transactions on quality, delivery and cost

ance programme used to track quality critical key performance indicators

parameters and approximately 1,100 suppliers have been assessed.

through the company’s Quality Management System (QMS). Furthermore,

Cipla received a warning letter from the FDA (US) on 25 February 2020,

Cipla has implemented several digitisation and automation projects toregarding significant GMP violations for finished pharmaceuticals at its Goa

reduce variability and ensure consistency in quality control processes. For

site in India.** Cipla reported the site was reinspected in August 2022 andexample, the company implemented a laboratory information manage-is working with the FDA to address the observations from the inspection.

SQ 5. SAFEG UAR D I N G Q UALIT Y & SAFE T Y O F MAR KE TE D PRO D U C TS
Cipla implements strategies to ensure the quality and safety of its mar-icy to mitigate the circulation of substandard and falsified medicines.

keted products. The company discloses the number of annual recalls

In an effort to mitigate falsified and substandard medicines, the com-it receives and conducts a Health Hazard Evaluation for each recalledpany has introduced an automated track and trace system with uniquebatch to assess the impact on public health. Additionally, it reports that it

product serialisation for the EU, and primary packaging serialisation for US-

responds to regulatory audit observations within defined timelines. The

bound products. Cipla reports automated tracking and tracing systems

company reported that if a falsified medicine is confirmed, it will promptly

outside the EU and US.The company reports that for its products marketed

notify authorisation holders, customers, regulatory bodies and relevantin India, it provides details of the primary manufacturer plant and discloses

authorities. However, the company does not disclose whether it has a pol-third party sourced product components on the packaging.

FIGURE 5 Depth and breadth of quality-assurance strategies
This table shows the types of strategies Cipla implements to maintain the production of quality-assured
products and to safeguard the quality and safety of products already in the market.
Quality-assurance strategies
Manufacturing quality-­

Strategies to standardise quality management systems and complianceassured products

monitoring tools across all manufacturing sites
Strategies to assesses third party suppliers on GMP compliance●●

Disclosure of the number of manufacturing sites with approval from astringent regulatory authority (SRA) or national regulatory authority(NRA) operating at maturity level 3 or 4 (ML3 or ML4)*
Safeguarding quality & safety

System for recalling products promptly and effectively and alerting theof marketed products

appropriate authorities in a timely and efficient manner●

A clear policy to mitigate the circulation of substandard and falsified
medicines, including to which authorities and/or organisations thecompany reports encounters of substandard or falsified medicines
Evidence of concrete strategies to mitigate the risk of substandard andfalsified medicines●

The company also reports thatits sites have been inspectedby multiple SRAs and by NRAs
operating at ML3*. However,outside of the company’s
API sites, there is no publicly
available information on whichof the company’s 47 manufacturing sites have approval fromat least one SRA and/or NRA
operating at ML3/4.*

Efforts to disclose the source of finished products, including specifying
the primary manufacturing plant and disclosure of product components●

and materials that are third-party sourced
Cipla reports that its automated track andtrace systems are implemented to othercountries outside the EU and US.

*As benchmarked against WHO Global
Benchmarking Tool (GBT).

**Cipla Limited, FEI 3004081307, at L138;
Ll39 - 146; L147/A; L147/1 - 147/3; S103 105; S107 - 112; M61 - 63, Verna, Goa.

24

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Cipla Ltd

RESEARCH & DEVELOPMENTR D1 . ADAPTIVE R& D
During the period of analysis, Cipla had one adaptive R&D project in its

and was approved by South African Health Product Regulatory Authority

pipeline, meaning the company was adapting a product to ensure it was(SAHPRA) in June 2022. This product is currently awaiting approval frombetter suited for LMIC settings. Cipla developed a granule-filled cap-

other regulatory bodies, such as the US FDA. It can be sprinkled on foodsule containing a 4-in-1 paediatric fixed-dose combination (FDC) of ARVs

without leaving an aftertaste, due to its granular texture and strawberry(abacavir, lamivudine, lopinavir, ritonavir) for the treatment of HIV. The FDC

flavour. Additionally, by developing a new FDC, a complicated dosage regi-

is heat-stable and does not contain alcohol or inappropriate solvents. The

men is simplified, which helps with treatment adherence. The development

HIV drug was developed in partnership with Drugs for Neglected Diseasesof this product has the potential to ease administration and improve out-

initiative (DNDi), Unitaid, Stellenbosch University, and Tygerberg Hospital

comes in children living with HIV.

R D2 . ACCESS PL AN N I N G
The company does not disclose having an overarching policy or structured

temporary authorisation received for the DRC during the period of analysis.

framework in place for systematically developing access plans during R&D

However, the company did not disclose further details on plans for registra-for its adapted products.

tion in countries in scope.

However, for the one adaptive R&D project example in scope, Cipla

To address affordability, the access plan includes transparent and pub-has a comprehensive access plan in place. The product, Quadrimune, waslicly available details on pricing plans for South Africa. Cipla has committed

developed in collaboration with product development partner DNDi, whoto offering Quadrimune at ex-factory prices of USD 15 for 120 capsules for

ensure that plans for equitable and affordable access are put in place dur-young children and infants. Ultimately, this commitment will price the druging the drug development process. The product was approved in SouthUSD 1 per day (USD 360 per year) for children weighing 10 to 13.9 kg. For

Africa and dispatched to the Democratic Republic of Congo (DRC), as per

younger children and infants, this price drops to USD 0.50 per day.

FIGURE 6 Example of a late-stage adaptive R&D project in Cipla’s pipeline
International

DiseaseDevelopment

Description of

Evidence ofNonproprietary Name (INN)

in scope

stage

Partner(s)the adaptationan access plan

4 in 1 combination of ARVs (abacavir/

HIV/AIDSApproved

Drugs forNew paediatric fixed

Equitable pricing

Neglected Diseases

dose combination

plan; Partnership withinitiative (DNDi),

with strawberryan accesss-oriented

Stellenbosch

flavour and granules,

organisation; Approved

University,

which ease adminis-

in South Africa andTygerberg Hospital,

tration and improve

temporarily authorised

Unitaid and others

adherencein the Democratic

lamivudine/lopinavir/ritonavir)

Republic of the Congo25