Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

Sun Pharmaceutical Industries Ltd
HQ: Mumbai, India • Ticker: SUNPHARMA • Stock exchange: NSE • Nr. of employees: 41,000+

CO M PANY SU M MARYSun Pharma enables access and product availability through its manufacturing
network, spanning 43 sites worldwide, and its presence across many low- and middle-income countries (LMICs). The company has successfully filed or registeredproducts in 63 countries in scope, with the ten products selected for this assessment having been prioritised by Sun Pharma for registration in lower-middle andupper-middle income countries. Sun Pharma expands access to its products byengaging in competitive tenders by governments and hospitals to ensure availability
in the public sector, while adhering to local pricing policies and competitor-based
pricing strategies in the private sector. However, only six of the ten assessed products are covered by an access strategy, and the company submitted no examplesof access strategies covering any low-income countries. The company has signed
licensing agreements that allow the company to market generic versions of treatments for HIV and COVID-19, but no specific information is provided regarding
the countries where Sun Pharma has registered these products. Sun Pharma uses
several strategies to reduce the risk of product shortages, including demand forecasting and buffer stock maintenance. Sun Pharma reports one adaptive late-stage
R&D project for a fixed dose combination of extended-release tablets treating type2 diabetes.

Main therapeutic areas
Anti-infectives; cardiology; dermatology; diabetology; gastroenterology;
gynaecology; nephrology; neurology;
oncology; ophthalmology; orthopaedic; psychiatry; respiratory; urology.
Business segments*
Active pharmaceutical ingredients(APIs); Emerging Markets; Indian
Branded Generics; US Business; Restof the World; Others.
Product categories
APIs; branded generics; consumer
health; innovative specialty medicines; generics.
Sales presence**
Sun Pharma reports sales in 49 countries in scope.

O PPO RTU N ITI ES FOR SU N PHARMAEngage further in adaptive R&D

and responsible pricing, Sun Pharma

manufacturing site to supply essen-and strengthen access planning for

can use access strategies to increase

tial HIV treatments to neighbouring

products in the pipeline.

the affordability and supply of essen-countries, Sun Pharma can expand the

Sun Pharma’s extended release fixed-

tial cancer medicines in its portfolio.

reach of its medicines to further coun-dose combination of dapagliflozin/

For doxorubicin, indicated for thetries in Africa, particularly low-income

glimepriride/metformin, indicated fortreatment of different types of cancer,

countries, by leveraging its manufac-

people with type 2 diabetes, demon-

including non-Hodgkin lymphoma,

turing capabilities in South Africa andstrates the company’s capability to

the company can use access strate-

Nigeria.

adapt products and simplify dosage

gies that include elements to address

regimens. Sun Pharma can further

affordability issues for patients paying

Expand registration of in-licensed

apply this expertise to adapt otherout of pocket. Sun Pharma can apply

products as a sublicensee.

products. For example, for the antiret-such strategies in Myanmar, the coun-

Sun Pharma is a sublicensee for aroviral products in its pipeline, it can

try with the highest out-of-pocket

dolutegravir licensing agreement facil-

adapt products to be more suitable forhealthcare spending in South-East Asia,

itated by the Medicines Patent Pool

population groups, such as children. It

where the company has registered thefor the paediatric formulation (10mg

can also develop its access plans for its

product.

scored, dispersible). Yet, the company

R&D projects to ensure they consider

has not registered this product in any

barriers to access, such as affordability

Leverage manufacturing presence tocountry in scope. The company canand supply.

address access-to-medicine gaps.

file for registration in countries within

Sun Pharma can leverage its large

the scope of the licence,*** prioritising

Expand access to essential cancer

manufacturing network and expand

countries with high disease burdens –products, such as doxorubicin

operations in countries where accessparticularly those where the company

In line with the company’s sustainability

gaps are prevalent. Drawing upon its

has previously successfully registered‘focus area’ of product accessibility

experience using its South African

another project.

*Sun Pharma also reports the following
segments: Global Specialty and Global
Consumer Healthcare business.

**Refers to countries in which sales are
conducted through suppliers, pooled procurement and/or the company sales
offices. As Sun Pharma did not verify its
company presence, this data was sourced
from the public domain and previous submissions for the 2021 AMR Benchmark.

***The licence for dolutegravir paediatricformulation covers 102 countries within
the scope of this Programme.

34Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries 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*

Revenue by region*

2022

2022

127,5932023

136,0310

100,000

113,737 67,432
135,353
200,000

2023

78,977300,000

134,439

400,000

500,000
bn INR● Indian Branded Generics ● US Business● Emerging Markets ● Rest of the World (RoW)● Active Pharmaceutical Ingredients (API) ● Others

141,6240

100,000

117,344 72,756
139,704
200,000

59,72585,633 65,827

300,000

400,000

500,000
bn INR● India ● United States of America● Emerging Markets ● Rest of the WorldPO 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,** Sun Pharma has at least

Of the in-scope products that Sun Pharma has in its portfolio, ten off-pat-

31 products within its portfolio.***ent medicines were selected for analysis for the themes EA2 (productregistration) and EA3 (expanding access and pricing strategies).
31+ products
These target a range of disease categories, namely cancer, bacterial infections, mental health disorders, asthma,
chronic obstructive pulmonary disease(COPD), and cardiovascular disease.

Product

Indication

Abacavir/lamivudine (ABC+3TC)

HIV

Atorvastatin

Ischaemic heart disease

Carbamazepine

Epilepsy
Bipolar affective disorder

Doxorubicin

CancerFluoxetine

Unipolar depressive disorders

Product is in Sun Pharma's portfolio
Product is not in Sun Pharma's portfolio***

Anxiety disorders
Gemcitabine

CancerGliclazide

Diabetes mellitus

Metoprolol

Hypertensive heart disease
Ischaemic heart disease*Financial year (FY) 2022 covers April
2021 – March 2022. FY 2023 covers April
2022 – March 2023. The company reports
the revenues from its Global Consumer
Healthcare and Global Speciality businesses as part of the listed businesssegments.

**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.

Sumatriptan

Migraine

Tranexamic acid

Maternal haemorrhage***Sun Pharma verified that the ten products selected for assessment are included
in its portfolio. However, the company did
not confirm which of the 102 products inscope are in its wider portfolio. Thus, theanalysis relies on data from Sun Pharma’s
India catalogue and India Product list
accessed on 14 June 2023.

35

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

EXPANDING ACCESSE A1 . ACCESS -TO - M E D I CI N E STR ATEGYSun Pharma reports a general commitment to expanding access, but doesity (CSR) division reports directly to the board of directors. However, it is

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

unclear whether the CSR committee or the board holds ultimate responsi-

company places emphasis on product accessibility and responsible pricing as

bility for access to medicine. Furthermore, the company does not disclose

crucial aspects of its sustainability focus, as highlighted in its Environment,

measurable and time-bound objectives for its access-to-medicine com-

Social, and Governance (ESG) strategy. Additionally, Sun Pharma has statedmitments, nor does it outline specific strategies for achieving sustainable

its commitment to provide uninterrupted access to quality-assured medi-

access and expanding patient reach. Establishing such objectives andcines. However, there is limited information available about the scope of thisstrategies is critical for guiding Sun Pharma’s access-to-medicine efforts

commitment, such as the countries and products covered.

and demonstrating the importance of access in the company’s long-term

Under Sun Pharma’s ESG strategy, the corporate social responsibil-

growth.

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

five are registered in at least one low-income country, where significant

product within its entire portfolio in 63 LMICs in scope. This demonstrates

gaps in access to essential medicines are prevalent.**

the company’s ability to register products with national regulatory authorities (NRAs) in LMICs in scope.

For a variety of its products, the company engages in mechanisms
designed to facilitate wider registration in LMICs. Several of the compa-

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

ny’s products have been registered through the World Health Organization

Programme, ten off-patent medicines were selected for assessment. Sun(WHO) Collaborative Registration Procedure (CRP) for WHO Prequalified

Pharma has filed at least one of these products in a total of 42 out of the

products in multiple countries in the AFRO region*** and the Philippines.

63 LMICs (67%) where it has pre-existing regulatory filings.* This shows the

These products include HIV medicines abacavir/lamivudine and dolute-company’s capacity to register across a wide geographic area. These ten

gravir/lamivudine/tenofovir disoproxil fumarate. Additionally, a few of the

products have all been registered in at least one country in scope, with one

company’s products (outside the product scope of this analysis) have been

product registered in a total of 23 countries. Out of the ten products, only

recommended for approval by ZaZiBoNa.†

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)

4

Atorvastatin

4

Carbamazepine

2

6

13
3

7
3

Gemcitabine

1

6

3

2

Gliclazide

6

3

Metoprolol

Atorvastatin, a medication used forthe management of cardiovascular disease, was the most widely
registered product, having beenregistered in 23 countries in scope.

62

Doxorubicin
Fluoxetine

2

12

7

3

Sumatriptan

1

Tranexamic acid

2

0

3

5

10

15

20

25

Sumatriptan, a migraine medication, is only registered in one
country in scope: India.

Number of registration filings● Registration filings in low-income countries● Registration filings in lower-middle income countries● Registration filings in upper-middle income countries

Doxorubicin, a chemotherapy drug indicated forthe treatment of multiple
cancers, has not been registered in any low-income
countries.

Neither tranexamic acid, a medicine
used for the treatment of maternal
haemorrhage, nor metoprolol, a
medicine used for hypertensive
disorders of pregnancy, is registeredin any low-income countries.

*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.

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

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

36Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

EXPANDING ACCESS
E A 3. E XPAN D I N G ACCESS AN D PR I CI N G STR ATEG I ES
In the country-specific examples provided by Sun Pharma, six out of the

Sun Pharma adopts a similar strategy for fluoxetine and gemcitabine,ten products selected for assessment are covered by an access strategy

participating in public sector tenders in countries in scope, while also

in the public and/or private market. Across the assessed products, Sun

supplying the private market – setting prices based on the competitor

Pharma reported access strategies in lower- and upper-middle income

landscape. For fluoxetine, the company participates in public sector ten-countries, with no examples of access strategies for low-income coun-ders in several countries in scope; this includes Kenya, which was selected

tries. Based on the examples of in-country access strategies submitted for

as a specific country example. However, it emphasises that participation

analysis, the company primarily participates in government and hospitalin tenders is not the primary strategy it employs to expand access. In thetenders, which can facilitate access to its products within the public sector.

Kenyan private market, Sun Pharma employs competitor-based pricing

However, the company only provides evidence of patient reach for two ofstrategies to supply the products. While the company provides evidence ofthe ten products, and it does not provide evidence of forecasting patient

the cumulative number of patients reached in five countries in scope wherereach for any of the ten products.

it supplies fluoxetine, including Kenya, it remains unclear whether the pric-

In the private sector, Sun Pharma adheres to local pricing policies andemploys competitor-based pricing strategies to determine the pricing of

ing strategies employed by the company ensure access to affordable prices
for all patients across the income pyramid.

its products. Examples of access strategies submitted for atorvastatin, gli-

For gemcitabine, Sun Pharma reports engaging in public sector tenders

clazide, and metoprolol show that the company sets prices for its productsin Thailand, as well as supplying the private market. However, the company

based on local pricing policies, including the respective external reference

does not provide any estimates regarding the number of patients reachedpricing system implemented in each country.

through these efforts. It remains unclear whether Sun Pharma consid-

For carbamazepine, fluoxetine and gemcitabine, Sun Pharma reports

ers affordability when setting prices for the private sector, especially for

implementing access strategies in both the public and private sectors ofindividuals that pay out of pocket. Although the company reports imple-

LMICs in scope.

menting a patient support programme for gemcitabine in Thailand, there

In Morocco, the company engages in government and hospital tenders to supply carbamazepine within the public sector. It also supplies theis a lack of available information regarding the programme’s details and its
effectiveness in ensuring access for patients within the country.

product in the Moroccan private sector, where it sets prices using compet-

For three assessed products, abacavir/lamivudine, doxorubicin, anditor-based pricing. The company reports evidence of cumulative patient

tranexamic acid, Sun Pharma did not report access strategies, indicating

reach in five countries, including Morocco, where it supplies the productthe company may not be taking steps to ensure the availability and afforda-

carbamazepine. Collectively, Sun Pharma estimates that approximately

bility of these products in countries in scope. Additionally, while evidence

523,000 patients were provided access to carbamazepine in five countries

was provided for improving the availability and affordability of sumatriptan,

in scope between April 2020 and April 2023.

it was not specific to any country within the programme’s scope.

FIGURE 2 How many products are covered by an access strategy?
For each of the ten products selected for assessment, Sun Pharma was requested to provide one
example of a country-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 of access 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.
Evidence of

Additional ­Public market

marketPrivateEvidence

forecasting

initiatives toaccess/­pricing

access/pricing

of patientpatient

improve affordability

strategies

strategies

reach

reach

and availability**

International
Nonproprietary Name
(INN)

Country

Abacavir/lamivudine

No country-specific(ABC+3TC)

access strategy

Atorvastatin

Bangladesh (LMIC)

Carbamazepine

Morocco (LMIC)

Doxorubicin

No country-specific

●
●

●

●*

●*

access strategy
Fluoxetine

Kenya (LMIC)●●

Gemcitabine

Thailand (UMIC)●●

Gliclazide

Sri Lanka (LMIC)●

Metoprolol

Nepal (LMIC)●

Sumatriptan

No country-specific●access strategy
Tranexamic acid

No country-specificaccess strategy

For these products, Sun Pharma provides evidence of implementing initiatives aimed at improving access to diagnostics
and education materials in countries in scope. While suchstrategies can play a critical role in improving patient outcomes and ensuring continuity of care, there is currently noevidence suggesting they can improve affordability.

*Sun Pharma provided aggregated patientreach for carbamazepine and fluoxetine,
and as such, the country-specific patientreach estimates are unknown.

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

37

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

EXPANDING ACCESSE A4 . E N GAG I N G I N LI CE N S I N G AC TIVITI ES
For Sun Pharma, five in-licensed products were selected for assess-of this product.

ment: dolutegravir (paediatric) and dolutegravir (adult), indicated for the

Sun Pharma is currently engaged in one exclusive licensing agreement

treatment of HIV; carbetocin, indicated for maternal haemorrhage; andwith Ferring Pharmaceuticals to distribute carbetocin, indicated for pre-molnupiravir and nirmatrelvir, indicated for COVID-19.

vention of post-partum haemorrhage. This formulation is stable at room

Sun Pharma was granted a non-exclusive voluntary licensing agree-

temperature and therefore offers advantages for use in LMICs over thement (NEVL) for dolutegravir (paediatric) and dolutegravir (adult) facilitatedcurrent first-line treatment oxytocin (which requires refrigeration). Sun

through the Medicines Patent Pool (MPP). For the paediatric dose and for-Pharma has only been granted co-marketing rights for heat-stable car-mulation, the company did not report where this product was registered andbetocin in India, exclusively within the private market. The product was

as a result, the impact of this NEVL in countries in scope is unknown. For

approved and launched in India in June 2021, and it was co-marketed withthe adult dose and formulation of dolutegravir, the company reports that it

the originator company Ferring Pharmaceuticals. The company did not

is a global supplier with 40 registrations in LMICs;* however the company

report further details on the licensing agreement, including whether theprovided neither details on the specific countries where the product is regis-

agreement has increased the number of patients receiving heat-stable car-tered, nor details of the impact of this licence on improving the affordability

betocin in India.

FIGURE 3 Registration filings of Sun Pharma’s in-licensed products**
This figure shows the number of LMICs in scope where Sun Pharma has filed for registration orregistered four in-licensed products out of the five selected for assessment, compared to the total
number of countries covered by the licensing agreement.***Dolutegravir (adult)

40

52

Dolutegravir (paediatric)

104

Molnupiravir

95

Nirmatrelvir

93

0

20

40

60

80

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

100

120

Countries

Sun Pharma was granted two NEVLs for COVID19 antivirals – molnupiravir and nirmatrelvir. The
nirmatrelvir agreement was facilitated through theMedicines Patent Pool (MPP). These agreements
were made after the COVID-19 vaccines were rolled
out, which reduced the demand for these products.
Consequently, the company has not filed theseproducts for registration in any LMICs within scope.
However, the company did report that molnupiravir
is currently under review with WHO for prequalification (PQ) and the company retains the right toregister and supply these products, should the needarise.

E A 5. I M PROVI N G PRO D U C T AVAI L AB I LIT Y
Sun Pharma’s manufacturing network comprises 43 manufacturing sites

Programme of the Ministry of Health of Morocco by making ARVs available

globally, including 29 finished dosage manufacturing sites and 14 API man-in this country. Sun Pharma supplies medicines such as antibiotics and anti-

ufacturing facilities. The company reports that its large manufacturinghypertensives in South Africa and Nigeria.

network, with facilities in multiple countries, provides increased flexibil-

Sun Pharma has stated that it undertakes technology transfers

ity that enables it to effectively service the markets in which it operates,

between its own manufacturing sites specifically pertaining to the trans-

thereby leading to improved product availability. The company reports thatfer of product processes and analytical methods from one site to anotherit operates several finished dosage manufacturing sites located in LMICs inwithin the same region in India. However, the details regarding these tech-scope, including in Bangladesh, Egypt, Nigeria and South Africa.

nology transfers and their impact on improving product availability within

Through the company’s manufacturing presence in South Africa, Sun

the region are currently unknown. Sun Pharma does not disclose being

Pharma reports supplying antiretrovirals (ARVs) to neighbouring coun-

involved in technology transfers with external stakeholders and/or partner-

tries in southern Africa. It also reports supporting the HIV/AIDS Treatment

ships to develop or enhance local manufacturing in countries in scope.

*Sun Pharma did not disclose which specific 40 LMICs these are. The correspondence of the countries with theProgramme’s geographic scope therefore
cannot be verified.

***The company did not provide registration data for the carbetocin licensing
agreement.

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

38

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

SUPPLY & QUALITY
SQ1 . D E MAN D PL AN N I N G AN D DATA S HAR I N G
Sun Pharma reports implementing demand forecasting in order to plan forpandemic providing updates on information such as sales, stock status andshort-, mid- and long-term requirements and to schedule production, using

raw material status of key medicines.

a forecasting system that operates up to 12 months in advance. It also

However, there is no publicly available information indicating whether

reports that its demand planning teams work closely with sales teams to

Sun Pharma engages in data sharing activities with external stakeholders

ensure adequate planning aligned with sales forecasts. In the financial year

from other countries, or beyond the context of COVID-19, to align supply

2021-2022, Sun Pharma reported that it had maintained regular commu-

and demand of its products.

nication with the Indian government since the beginning of the COVID-19

SQ2 . D E LIVE RY PE R FO R MAN CE
Sun Pharma reports having systems in place to monitor and review inter-

Furthermore, Sun Pharma does not report details about how successfully

nal delivery performance. However, it has not reported any information

it fulfils its supply commitments to national and international procurement

about what these systems consist of and/or how they are employed. The

agencies. Additionally, the company does not publicly report its processes

company states that it proactively communicates with stakeholders in caseto ensure the consistent and timely delivery of quality-assured products toof delivery delays. However, no further details were provided regarding

LMICs.

its communication strategies or other measures taken in such situations.

SQ3. STO CKO UTS AN D S H O RTAG ES M ITI GATI O N
Sun Pharma has implemented some strategies to promote a continuous
supply of products and mitigate the risk of shortages and stockouts.
The company reports maintaining a buffer stock of critical components

Furthermore, the company has established a Strategic Procurement
Committee to identify potential supply risks and implement mitigation
measures. The company also reports coordinating with various stake-such as raw materials, excipients, APIs and finished products. It has also

holders, including clearing and forwarding agents, who are responsible

stated that supply chain continuity, along with a focus on inventory optimi-

for ensuring that the company’s products are cleared through customs.

sation, is a top priority for the financial year 2023. However, no information

Ultimately, coordination with various stakeholders helps to ensure thewas provided regarding strategies to optimise inventories or conduct

overall availability of products.

audits of the company’s stock. Additionally, it is not clear in which LMICs in

Sun Pharma produces APIs, both to fulfil its product requirement andscope the company holds stocks or if it has taken any steps to decentralise

supply other manufacturers. This approach has the potential to reducestocks of critical components.

the company’s dependence on third-party suppliers and ensure a reliable

To reduce supply risks, Sun Pharma reports sourcing critical items fromsupply of APIs. With a portfolio comprising around 380 APIs manufac-

multiple suppliers and states that it evaluates alternative suppliers for criti-

tured across 14 sites (nine of them located in India) and supplied to overcal or non-substitutable raw materials. In 2021-2022, Sun Pharma reported

60 countries, Sun Pharma has significant API capabilities. However, thesourcing 61% of its direct procurement from local suppliers with the aim ofcompany did not provide specific details on its approach to scaling up API

strengthening its supply chain, improving operational flexibility and reduc-production in response to surges in demand in LMICs, thereby preventing

ing costs.

stockouts and shortages.

FIGURE 4 What steps is Sun Pharma 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 meet

Sun Pharma has manufacturing
sites in LMICs in scope, suggesting the company likely maintains
regional stocks. However, it does
not disclose specific strategies toexpand or decentralise its stocks.

surges in demand, when applicable
Other initiatives to fulfil emergency orders and/or surges in demand

Sun Pharma reports its percentage
of procurement sourced from local
suppliers. However, it does not provide a definition of local suppliers
nor the location of its local sourcing
approach.

●

Sun Pharma reports using multiple
upstream suppliers for critical items.
However, it does not report a specific strategy to qualify alternative
suppliers.

39Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries 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
Sun Pharma reports that its own and third-party manufacturing sites

new vendors for compliance with its Supplier Code of Conduct and regu-

maintain a quality management system consistent with international

latory requirements. The company states that its vendor performance isgood manufacturing practice (GMP). This includes tracking of corrective

tracked regularly, for which it uses a scorecard mechanism.

and preventive actions (CAPA), mitigating adverse drug events, field alert
reporting, and a recall process.

During the period of analysis, the company received official requests
for corrective action from SRAs related to non-conformities with cGMP. In

The company does not publicly disclose the number of manufactur-

December 2022, the FDA (US) issued a warning letter concerning signifi-

ing sites that have received approval from at least one stringent regulatory

cant GMP violations for finished pharmaceuticals at the company’s Halol**

authority (SRA) or NRAs operating at maturity levels 3 or 4.* However, itsite in India and placed the Halol site on Import Alert 66-40, with 14 prod-states that an undisclosed number of its manufacturing facilities are cer-

ucts exempted from import alert, subject to certain conditions. In April

tified by international regulatory bodies, including the FDA (US); EMA

2023, a consent decree correspondence/non-compliance letter was issued(Europe); MHRA (UK); TGA (Australia); SAHPRA (South Africa); BfArM

by the FDA (US), and the company must implement corrective actions at(Germany); ANVISA (Brazil); MFDS (South Korea) and PMDA (Japan). The

its Mohali*** site before releasing further final product batches into thecompany is engaged in the WHO prequalification programme, whereby rel-

United States. In 2022, Health Canada also issued non-compliant ratingsevant manufacturing sites are assessed in line with WHO GMP.

to Sun Pharma’s Halol** , Mohali***, and Paonta Sahib† sites. The company

The company reports that it conducts audits of all its manufacturing

reports that it is taking the required corrective steps.

sites, contract facilities and vendors, and assesses third-party suppliers andSQ 5. SAFEG UAR D I N G Q UALIT Y & SAFE T Y O F MAR KE TE D PRO D U C TS
Sun Pharma reports that it has a policy to address complaints concerningogy, which works to ensure the authenticity of its products. However, it ispotentially substandard products, including a system for recalling products

unknown whether this system is applied in LMICs.

from the market and alerting appropriate authorities within the required

Sun Pharma’s product packaging contains important information suchtimelines by providing a recall return card and a destruction certificate.

as the safe use of products, the sourcing of ingredients, and guidance on

However, the company did not provide further details of the policy.

appropriate storage conditions. The company reports that for every prod-

The company takes steps to tackle the risk of substandard and falsified
medicines. For instance the company uses ‘Track and Trace’ technol-

uct, the necessary storage conditions are outlined, and the sourcing plant
address is provided.

FIGURE 5 Depth and breadth of quality-assurance strategies
This table shows the types of strategies Sun Pharma implements to maintain the production ofquality-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●

The company reports efforts
to harmonise compliance
processes as part of its quality
practices, but it does notprovide concrete evidence on
whether it implements specificstrategies to limit variability
in manufacturing processes
between sites.

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

**Halol Baroda Highway Halol, Gujarat
India, 389350.

***Unit 1 Plot A-41, Sez Industrial Area,
Phase Viii A, Mohali, Punjab, 160071 India.

●

While the company reports
implementing a ‘Track andTrace’ technology, it isunknown whether this system
is applied in LMICs.

†Paonta Sahib District Sirmour-Village
Ganguwala, Himachal Pradesh India
173025.

40

Generic & Biosimilar Medicines Programme 2023 - Company Profiles ▶ Sun Pharmaceutical Industries Ltd

RESEARCH & DEVELOPMENTR D1 . ADAPTIVE R& D
Sun Pharma has one adaptive R&D project in its pipeline to develop a prod-

glimepiride and metformin for the treatment of type 2 diabetes melli-

uct that is better suited for LMIC settings. During the period of analysis,tus. Extended-release FDC tablets simplify dosage regimens and reducethe company provided an example of a late-stage (phase II and beyond)dosage frequency, thus improving adherence and patient outcomes.

adaptive R&D project. This project, currently in Phase III of clinical develop-

This is advantageous for both patients and health systems, especially inment, is a fixed dose combination (FDC) of extended release dapagliflozin,

resource-limited settings.

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

product for registration in one country in scope, specifically India. Whilst

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

registration is a necessary first step to ensure availability in a country, there

for its adapted products.

is no evidence that the company’s access plan for this product considers

For the one example of adaptive R&D submitted, the company pro-other components conducive to access, such as affordability and supply.

vided evidence of an access plan. This access plan consists only of filing the

FIGURE 6 Example of an adaptive R&D project in Sun Pharma’s pipeline
International

DiseaseDevelopment

Description of

Evidence ofNonproprietary Name (INN)

in scope

stage

Partner(s)the adaptationan access plan

Dapagliflozin/glimepiride/metformin

Diabetes mellitus

Phase III

N/A

Extended release fixed-

Registrationdose combinationplans in India

extended release FDC

41