The US FDA approvals of Abbreviated New Drug Applications (ANDA) remained lowest in the year 2021, mainly due to adverse worldwide impact of Covid-19. The US FDA approved only 635 ANDA during 2021 as compared to 761 in the previous year. In the year 2017, US FDA approved 844 ANDAs and slowly started diminishing thereafter. The R&D based Indian pharma majors secured 210 ANDA approvals from US FDA which worked out to 33 per cent of total approvals. Last year Indian companies received 276 ANDA approvals, 36.3 per cent of total approvals. The total tentative approvals were also declined to 116 as against 125 in 2020.

The R&D investments always play an important role in getting US FDA approvals. Alkem Laboratories, a Rs. 8,850 crore plus pharma major, has grabbed highest number of 21 approvals during 2021 among Indian companies. This was followed by Aurobindo Pharma and Cadila Healthcare & Zydus Group also received 19 approvals respectively. Dr Reddy’s Laboratories and Gland Pharma also marked with 15 and14 ANDA approvals each. Sun Pharma and Taro Pharma notched up total 17 approvals.  This was followed by Hetero Labs and Alembic Pharma 10 each. Other major pharma majors like Glenmark Pharma, Lupin, Stride Pharma, Unichem Laboratories, etc also won better approvals.

Alkem Laboratories R&D expenses during the first half ended September 2021 reached at Rs. 250 crore, or 4.7 per cent of total revenue from operations compared to Rs. 258 crore in corresponding period of last year. So far, the company has filed a total of 157 ANDAs and 2 new drug applications (NDA) with the US FDA. Of these, it has received approvals for 116 ANDAs (including 14 tentative approvals) and 2 NDAs. In first half of 2021-22 It filed 8 ANDAs with the US FDA and received 12 approvals (including 2 tentative approvals). It invested Rs. 532 crore or 6.0 per cent of its revenues in R&D during year ended March 2021 as compared to Rs. 472.6 crore or 5.7 per cent of its revenues in FY 2019-20.

Similarly, Aurobindo Pharma filed 681 ANDAs on a cumulative basis upto the end of September 2021 with US FDA and it received approval for 456 ANDAs during September quarter including 3 injectables. Aurobindo’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, EU, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas.

Cadila Healthcare and Zydus Group cumulatively received 19 ANDAs approval from US FDA during 2021.During the quarter ended September 2021, the company received approval for the world’s first Plasmid DNA vaccine for Covid-19, ZyCoV-D. Further, the company also received approval from the DCGI to conduct phase III trials for the two doses regimen of the vaccine.

Zydus Cadila has received an order to supply one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, to the Government of India at Rs. 265 per dose and the needle-free applicator being offered at Rs. 93 per dose, excluding GST. The pricing has been decided in consultation with the Government of India.

Zydus Cadila’s US subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the US FDA to market pimavanserin capsules in the strength of 34 mg (USRLD: Nuplazid capsules). Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The drug will be manufactured at the group’s formulation manufacturing facility at SEZ Ahmedabad. The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Dr Reddy’s Laboratories invested Rs. 900 crore in R&D activities during the first half ended September 2021. DRL received 15 ANDA approvals during 2021. The company launched Covid-19 products like Sputnik V vaccine, remdesivir, Avigan (Favipiravir) and 2-deoxy-D-glucose (2-DG). It has commercialized all these products in India and some of these products in overseas markets. Currently, the company is conducting clinical trials for Sputnik Light, molnupiravir and are also developing several other Covid drugs for treatment ranging from mild to severe conditions.

Gland Pharma’s total R&D expense was Rs. 102 crore during the first half ended September 2021. This worked out to 4.5 per cent of revenue. It opened new R&D centre, and expanded its R&D team having capabilities in development of complex APIs. The company filed 5 ANDAs, 3 DMFs during the quarter ended September 2021 and received 5 ANDA approvals. As on September 30, 2021, the company along with its Partners have filed total 291 ANDAs, out of which 244 were approved and 47 are pending approval.

Sun Pharma, a Rs. 33,200 crore plus leading pharma company in India, has invested Rs. 1,129 crore on R&D activities and this worked out 5.9 per cent of sales. Sun Pharma’s R&D efforts span across both specialty and generic businesses and it continue to invest in building the pipeline for various markets including the US, Emerging Markets, RoW Markets and for India. The company has a comprehensive product offering in the US market consisting of approved ANDAs for 508 products while filings for 88 ANDAs await US FDA approval, including 20 tentative approvals. During 2021, Sun Pharma and Taro received 17 ANDA approvals from US FDA.

Hetero Labs’, unlisted pharma major, has set up R&D division which played a crucial role in developing an expansive product basket to meet diverse market requirements across the globe. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, which has been approved by top pharma regulatory bodies of the world. Its portfolio includes 300+ products encompassing major therapeutic categories such as HIV/AIDS, oncology, cardiovascular, neurology, hepatitis, nephrology etc. Hetero has a strong global presence in over 126 countries and focusses on making affordable medicines accessible to patients worldwide. The company has grabbed 10 ANDA approval during 2021 from US FDA.

Hetero has been the first company to launch the licensed version of generic remdesivir under the brand name ‘Covifor’ in India for treating severely infected patients and followed it up with favipiravir (Favivir). As of today, the company is among the largest manufacturers of remdesivir globally.

Thus, Indian pharma companies have established strong presence in the global market with investments in R&D activities. Lupin, Glenmark Pharma, Alembic Pharma, Strides Pharma, etc have also spread their wings in highly regulated markets. Lupin’s cumulative ANDA filings with the US FDA stand at 444 as of September 30, 2021. Glenmark Pharma has filed 11 ANDA applications with the US FDA including 3 filings from Monroe in first half of 2022, and is on track to file 18-20 ANDAs in FY22 including 4-5 filings from Monroe Glenmark’s marketing portfolio through September 30, 2021 consists of 175 generic products authorized for distribution in the US market.