AMR Benchmark Opportunities: progress update

Generic medicine manufacturers

Aurobindo Pharma Ltd
This table is part of a November 2023 report that looks at what actions each company in scope of the Antimicrobial
Resistance (AMR) Benchmark has taken with regards to each of the Opportunities set out in its 2021 AMR Benchmark
Report Card. The full 2021 Report Card is also included in this PDF.

2021 O PPO RTU N IT Y

2023 U PDATE

What was the Opportunity shared in the AMR Benchmark?

What progress has been made on this Opportunity?

Increase public disclosure on environmental risk

Aurobindo publicly reports that it performed mass balance

management.

calculations for antibiotics and ensured compliance withAurobindo publishes information on some of the com-discharge limits, in line with the AMR Industry Allianceponents of its general environmental risk-management

guidelines. Additionally, the company publicly reports thatstrategy. It can publish more information on how it manages

some manufacturing sites have implemented Zero Liquid

environmental risk related to antibiotic discharge into theDischarge (ZLD) systems. While Aurobindo manufactures

environment to curb AMR. While Aurobindo reports that

more than 99% of its API in-house, it publicly reports that

all its own sites are compliant with set limits, it can provide

suppliers have been asked to adopt the AMR Industry

clear evidence by publicly disclosing its progress in imple-Alliance guidelines, including discharge targets.

menting the strategy and by publishing the audit results ofown and suppliers’ sites, including antibacterial discharge
levels if applicable.
Expand access and ensure adequate supply of

Aurobindo reports it has extended the reach of its antibiotic

antibacterial and antifungal medicines in more accessportfolio from 34 to 41 countries in Africa and Asia. Thecountries.

number of products offered in the antibiotic portfolio has

Aurobindo has a Day-1 generic policy by which it introduces

increased from 20 to 25, encompassing products such asa generic product as soon as the patent on a brand expires

ciprofloxacin, azithromycin, ampicillin/sulbactam, piperacil-for the EU and USA. It can expand access to its genericlin/tazobactam and ertapenem. The company has registeredantibiotics and antifungals listed on the 2021 WHO EML toertapenem in 15 countries, and filed for registration in sevenmore products and countries, allowing for generic options

additional countries across Africa, Latin America and Asia.

to be made available in access countries as soon as the orig-In addition, Aurobindo reports its intention to manufacture

inator’s patent expires.

and market antifungals such as liposomal amphotericin B
and posaconazole in the near future.

Expand adaptations to brochures and packaging to

Aurobindo has reported filing for regulatory approval ofconsider more patient needs.

bilingual packaging for its antibiotics in African countries.

In order to support the appropriate use of its antibacterial

The company does not report details of any further packag-and/or antifungal medicines by patients, Aurobindo adapts

ing adaptations for its antibiotics.

brochures to take account of local languages. It can further
adapt its brochures and packaging to consider literacy
levels, paediatric use, environmental conditions and patientadherence to treatment.

29

Antimicrobial Resistance Benchmark 2021

AUR

Overall Performance
2020

2021

31% 71% ▲Access to Medicine Foundation

Aurobindo Pharma Ltd
Generic medicine manufacturer
Stock exchange: NSE • Ticker: AUROPHARMA • HQ: Hyderabad, India • Employees: 23,000

AUR
PERFORMANCE
Aurobindo is the leader among the generic medicines manufacturers inPerformance in the Benchmark

0%

scope and performs well in its evaluated Research Areas.
Responsible Manufacturing: Performs well. Reports environmental riskmanagement strategy for own sites and suppliers; co-leads in reporting
compliance with limits at own sites.
Appropriate Access: Middle-performing. Files its off-patent/generic
medicines for registration in access countries. Reports some strategies
to expand access and ensure continuous supply of its relevant product.

comprehensive conflict of interest mitigation for its educational

32/ 4550%

100%

Performance by Research Area
R&D

Points0%

0/ 067%

Manufacturing

10/ 1560%

Access

9/ 1587%

Stewardship0%

Stewardship: Performs strongly. It does not promote antibacterial
and/or antifungal medicines to healthcare professionals. It reports

Points71%

Overall score50%

13/ 15100%

How Aurobindo was evaluatedprogramme. It adapts brochures for patients.
A R&D

12.1 2.2 2.3 2.4

3

●

●

●

●

123

B Manufacturing ●

●

●

●

●

1.1

1.2 1.3 2.1 2.2 2.3

3C Access

●

●

●

4

567C Stewardship

●

●

●

●

●

●

●

●

● ● ● Scored●

Not scored

OPPORTUNITIES FOR AUROBINDOCHANGES SINCE 2020

Increase public disclosure on environmental risk management. Aurobindo publishes information• Since 2020, Aurobindo has extended the envi-on some of the components of its general environmental risk-management strategy. It can publish

ronmental risk management strategy require-more information on how it manages environmental risk related to antibiotic discharge in to envi-

ments of its own sites to its suppliers.

ronment to curb AMR. While Aurobindo reports that all its own sites are compliant with set limits,• Since 2020, Aurobindo reports that all its own

it can provide clear evidence by publicly disclosing its progress in implementing the strategy andsites that manufacture antibacterials are com-

by publishing the audit results of own and suppliers’ sites, including antibacterial discharge levels ifapplicable.

pliant with discharge limits.
• Aurobindo reports that it fully decouples

Expand access and ensure adequate supply of antibacterial and antifungal medicines in more

incentives for sales agents from sales volumes

access countries. Aurobindo has a Day-1 generic policy by which it introduces a generic product asin emerging markets to help prevent the inap-

soon as the patent on a brand expires for the EU and USA. It can expand access to its generic anti-

propriate use of its antibacterial medicine. Itbiotics and antifungals listed on the 2021 WHO EML to more products and countries, allowing forsells antibacterial and antifungal medicines

generic options to be made available in access countries as soon as the originator’s patent expires.

only through tenders in Europe and the US.

Expand adaptations to brochures and packaging to consider more patient needs. In order to support the appropriate use of its antibacterial and/or antifungal medicines by patients, Aurobindo
adapts brochures to take account of local languages. It can further adapt its brochures and packaging to consider literacy levels, paediatric use, environmental conditions and patient adherence totreatment.

40Antimicrobial Resistance Benchmark 2021

Access to Medicine Foundation

SALES AND OPERATIONS

AUR
Total income by business segment

Therapeutic areas: Anti-allergies, Antibiotics, Anti-diabetics, Anti-retroviral,

2020*

Cardio-vascular (CVS), Central nervous system (CNS), gastroenterology.

2021*

Business segments: Pharmaceuticals (including APIs and formulations)0

Product categories: Generic medicines, Biosimilars

230,985.1
247,746.2
100,000

200,000

300,000
mn INR*Financial year: April 2020 - March 2021

Pharmaceuticals

M&A since 2020: In February 2020, Aurobindo finalised acquisition of certain Profectus BioSciences Inc assets, including preventative and therapeutic R&D assets to develop vaccine for infectious diseases, for USD 11.29 mnand created a new subsidiary called Auro Vaccines LLC.

AUR
Total income by region
2020*

116,782.6

2021*

121,174.9

050,000

India

United States

100,000

72,767.6
81,221.6

150,000

Europe200,000

250,000
300,000
mn INR
Rest of world*Financial year: April 2020 - March 2021

PORTFOLIO for pathogens in scopeMid-sized portfolio: At least 39 products: 32 antibacterial medicines; 2antibacterial vaccines; 5 antifungal medicines
Off-patent/generic medicines: 6 of 39 were selected for analysis* (amoxicillin [A], amoxicillin/clavulanic acid [A], cefuroxime [W], ciprofloxacin [W],fluconazole [F], terbinafine [F])

AUR
Products on the market
2032 5204060● Antibacterial vaccine● Antibacterial medicine● Antifungal medicine

AWaRe medicines**: 11 Access group; 18 Watch group; 2 Reserve groupAnti-TB medicines**: 1PERFORMANCE BY RESEARCH AREA

ARESEARCH & DEVELOPMENT

As a generic medicine manufacturer, Aurobindo
is not evaluated in this Research Area.

BRESPONSIBLE MANUFACTURING Evaluated: antibacterials manufacturing (APIs and drug products)

B.1

Environmental risk-management for own

regulatory standards. It reports auditing the pri-sites and suppliers; tracks compliancevate plants on a yearly basis which includes

with limits at own sites

checking the suitability of technologies used forlator requested official corrective action

Aurobindo reports a strategy to minimise theprocessing waste and protocols for preventing

Aurobindo reports that its own sites and suppli-

environmental impact of wastewaters and solidcontamination.

ers have a system to maintain high-quality anti-

waste from antibacterial manufacturing at its

B.3

System in place to maintain production
quality for own and suppliers’ sites; regu-

bacterial production consistent with internaPublicly discloses some information ontional GMP standards. This includes periodic

reports setting discharge limits for all antibacte-environmental risk managementrisk-based audits and tracking of corrective andrials manufactured at its sites, based on PNECs

Aurobindo publishes some components of its

preventive actions. There is limited informa-

to limit AMR, as recommended by the AMR

environmental risk-management strategy. Thistion on whether Aurobindo requires its suppli-

Industry Alliance. It also reports quantifying dis-

includes disclosure of the ongoing implemen-

ers to audit their own suppliers. In September

charge levels at all sites using a mass balancetation of necessary processes to deactivate

2019, an FDA drug quality inspection identified

approach, supported by chemical analysis for

API residues in wastewater. Since 2019, it is a

non-conformities with cGMP at one of the com-beta-lactams and cephalosporins. All its 15 sites,

member of the AMR Industry Alliance, which

pany’s sites that manufactures antibacterialsof which 4 are ZLD, are reported to be compliant

publishes a list of recommended antibacte-(Polepally, Mahaboob Nagar, India), resulting inwith discharge limits.

rial discharge targets. Aurobindo publishes that

official requests for corrective action. Aurobindo

Aurobindo requires third-party suppliers

mass balance estimations of antibiotics are con-reports that the issue of non-conformities withof antibacterials to follow the same standards,ducted. The corresponding results or the dis-cGMP have since been resolved with no impact

including audits every five years. It reports pro-charge levels themselves are not published.

on business continuity, but the regulatory status

curing around 1% of its antibacterial API volume

Aurobindo also does not publish: (1) the results

remains as is because of delays to FDA inspec-from 2 supplier sites, which are both ZLD sites.

of environmental audits, whether conducted attions due to the COVID-19 pandemic.

No antibacterial drug products are procured

its own sites, the sites of suppliers or externalfrom suppliers.

private and public waste-treatment plants; (2) asites, including audits at least every five years. It

Aurobindo requires external private andB.2

list of these suppliers and plants.

public waste-treatment plants to follow local* See Appendix VII for information about
eligibility criteria for products.
** Listed on the 2019 WHO EML.

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Antimicrobial Resistance Benchmark 2021

CAccess to Medicine Foundation

APPROPRIATE ACCESS & STEWARDSHIP – ACCESS

Evaluated: access activities relating to antibacterial & antifungal medicines & vaccines in 102 access countries***
Aurobindo is not eligible for indicators: C.1.1,tributors. Between April 2020 and March 2021,icines. To mitigate against substandard and fal-C.1.3, C.2.1 and C.2.3. For more information, see

Aurobindo estimates to have reached 600,000

sified products, it uses security features suchAppendix VII.

patients in Vietnam with its amoxicillin/clavu-as tamper-proof stickers, hot-glue sealing tech-lanic acid generic version.

niques, self-destructing packing materials andC.1.2 Filed to register off-patent/generic medicines in 19 access countries on average

serialisation.
C.3

Some strategies to ensure continuous
supplyAurobindo performs above average, filing all its
six relevant off-patent/generic medicines for

Aurobindo has an average performance, withregistration in 19 access countries on average.

strategies reported in all four areas assessed.

Its most widely filed relevant product is amoxi-

It ensures accurate demand planning and data

cillin/clavulanic acid filed in 35 access countries.

sharing by having a monthly rolling forecast.

Two of its relevant products are filed in less than

Aurobindo has a direct-selling model where

10 access countries. Five of its relevant products

demand is directly generated by its customers or

are filed for registration in at least one LIC.

driven by tenders. Aurobindo mitigates against
shortage risks by keeping a buffer stock for its

C.2.2 Some strategies to expand access to

key starting material, APIs and finished prod-off-patent/generic medicines

ucts. It reports manufacturing more than 99%

Aurobindo has an average performance. It aimsof its API in-house. Aurobindo’s manufacturing

to expand access to its off-patent/generic med-facilities are located in India. It supplies APIs toicines in access countries through afforda-

low- and middle-income countries and aims toble prices, tenders and direct sales to its dis-

improve their capacity to produce finished med-CAPPROPRIATE ACCESS & STEWARDSHIP – STEWARDSHIP

Evaluated: stewardship activities relating to antibacterial & antifungal medicines globally
C.4

Comprehensive COI mitigation strategies

mote such medicines to healthcare profession-in place for its educational programmeals, the company is not eligible to be assessed on

Aurobindo performs strongly in conflict of inter-marketing materials.

est (COI) mitigation for the one AMR-related
educational programme for HCPs assessed

C.6

Makes one type of brochure and/or
packaging adaptation to facilitate appro-by the Benchmark. The programme has all

priate use by patients

three COI mitigation strategies looked for by
the Benchmark: (1) content is developed inde-

Aurobindo adapts brochures to facilitate thependently from its marketing department; (2) aappropriate use of amoxicillin/clavulanic acid bypledge not to provide financial or material incen-patients. It is middle-performing in this meas-

tives to participants; and (3) a policy of not using

ure, taking account of language. Aurobindo hasbranded materials.

translated package inserts for amoxicillin/clavulanic acid in Vietnamese.

C.5

Does not promote its antibacterial and/or antifungal medicines

C.7

AMR Surveillance

Aurobindo performs strongly in sales practices.

As a generic medicine manufacturer, Aurobindo

It does not deploy any sales agents to promote

is not assessed in this indicator nor does it report

its antibacterial and/or antifungal medicines toany involvement in AMR surveillance activities.

healthcare professionals. Since Aurobindo does
not develop or use marketing materials for antibacterial and/or antifungal medicines to pro-*** 102 low- and middle-income countries where better access to medicine ismost needed.

42