R&D based Indian pharma players secure 125 final ANDA approvals from US FDA during first half of 2018

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Indian Pharmaceutical companies and their subsidiaries have received 125 final ANDA approvals from US FDA during the first half ended June 2018 out of total 323 Abbreviated New Drug Applications (ANDA) approvals. This worked out to around 39 per cent of total approvals basically due to higher investments in R&D activities. Similarly, these companies received 22 tentative approvals out of total 71 tentative approvals by the US FDA. The approval rate is slightly lower compared to first half of 2017 in which US FDA approved total 387 ANDAs and 85 tentative products, and out of this Indian companies secured 137 ANDA approvals and 32 tentative approvals.

Aurobindo Pharma remained star performer and grabbed the highest level of final approval of 22 ANDA approvals followed by Zydus Pharma (16 ANDAs), Strides Shashun (12) and Cipla (11). Similarly, Lupin got 8 ANDA approvals and Sun Pharma Global and Taro Pharma also received 8 approvals. This was followed by Dr Reddy’s Laboratories and Glenmark Pharma 7 ANDA approval each during the first half ended June 2018. Further, Aurobindo received highest number of tentative approvals during the first half.

For the full year ended December 2017, Indian companies received final approval for 304 ANDAs out of 846 ANDA approvals and 61 tentative approvals among 171 total tentative approvals from US FDA. The investments in R&D has started yielding positive results for Indian players. The company’s focus on providing complex and speciality products, customer-centricity, regulatory compliance, quality improvement and operational efficiency will play important role in coming years. Indian companies are not only focusing on highly regulated markets, but are also moving in emerging markets in a big way.

Aurobindo’s R&D expenditure went up to Rs.667 crore during the year ended March 2018, which worked out to 4 per cent of its revenues of Rs.16,500 crore. Its sales in US increased to Rs.7,442 crore from Rs.6,827 crore in the previous year, accounting 45 per cent of consolidated revenue. It filed 47 ANDAs with US FDA including 16 injectables in 2017-18 and received 49 ANDAs including 7 injectables. The company launched 38 products including 6 injectable. On a cumulative basis, Aurobindo filed 478 ANDAs with US FDA and received approval for 361 ANDA including 34 tentative approvals.

Lupin, the third largest pharma giant in India, has incurred R&D expenditure of Rs 1,851 crore during 2017-18, lower than previous year of Rs.2,310 crore. R&D expenditure worked out to 11.9 per cent of sales as against 13.5 per cent in the previous year. It filed 36 ANDAs and received 24 approvals from the US FDA and its cumulative ANDA filings with US FDA stand at 398 as at the end of March 2018. It received total 235 approvals. It has now 36 First-to File (FTF) filings including exclusive FTF opportunities. Lupin now has 158 products in the US generic market. The company’s net sales declined by 9.1 per cent to Rs.15,560 crore during 2017-18 due to US FDA actions and one-time impairment on the Gavis acquisition. The company is now focusing on resolution of the warning letter on Goa and Indore Unit 2. Its sales in US declined by 28.7 per cent to Rs.5,894 from Rs.8,263 crore in the previous year.

Cipla has invested Rs.1,084 crore in R&D activities which worked out to 7.1 per cent during 2017-18. Its sales in US declined by 1.6 per cent to Rs.2,587 crore from Rs 2,629 crore in the previous year. The company filed total 249 ANDAs upto the end of March 2018 of which it received approval for 145 ANDAs and 26 tentative approvals. Currently 78 ANDAs in pipeline for approvals with US FDA. The company is planning to file 20 more products shortly with investments in R&D.

Dr Reddy’s Laboratories, which is passing through challenging phase due to US FDA warning letters, has spend Rs.1,827 crore for R&D during 2017-18 as against Rs.1,955 crore in the previous year, a de-growth of 7 per cent. It is focusing on building complex generics, biosimilars and differentiated products pipeline. This worked out to 12.9 per cent of revenues as compared to 13.9 per cent in the last year. Its US sales declined by 6 per cent to Rs.5,982 crore from Rs.6,360 crore and US sales worked out to 42 per cent of its sales as compared to 45 in the last year. As at the end of March 2018, DRL has cumulatively 107 ANDA filings pending for approvals with US FDA.

Zydus Cadila has strength its regulatory pipeline and it filed 26 ANDAs during 2017-18 with US FDA. Its cumulative filings touched to 330 and it received 77 ANDA approvals taking the total to 186 product approvals upto the end of March 2018. The company entered into a definitive agreement with Medicure International Inc. a subsidiary of Medicure Inc to commercialize its 505 (b) (2) New Drug Application (NDA) product, pitavastatin magnesium in the US. The launch, which i9s used to manage cholesterol levels, marks the first branded product launch for Zydus in the US.

Glenmark Pharmaceuticals is investing significant amount on R&D activities through its five R&D centers globally. During 2017-18 it received total 21 ANDA approvals, comprising 18 final and 3 tentative approvals. Its marketing portfolio consists of 131 generic products authorized for distribution in the US market. It has currently 62 applications pending in various stages of approval process with the US FDA of which 28 are Paragraph IV application. It has a pipeline of 7 new molecular entities (NMEs), which includes 2 new chemical entities (NCEs) and 4 new biological entities (NBEs) and a biosimilar candidate, in various stages of clinical development focused in the therapeutic areas of oncology, respiratory and dermatology. It has also 3 specialty products in clinical development targeting key indications in the respiratory segment.

Strides Shasun incurred R&D expenditure of Rs.118 crore during the financial year 2017-18 and filed 12 ANDAs and planning to file 15-20 ANDA every year. During April and May 2018 it filed 5 ANDAs. It received 14 ANDA approvals during the year ended March 2018 and 3 additional approved during April and May 2018. The company’s US sales reached at Rs.774 crore in 2017-18. It is managing its business with the help of 7 manufacturing facilities spread across three continents including 5 US FDA approved facilities.

Thus, Indian companies have established strong presence in highly regulated market with investments in R&D. Despite stiff generic competition these companies are able to file more and more ANDAs and getting higher numbers of approvals from regulatory bodies.

US FDA Approvals Jan-June  2018

Company Jan-June 2018
AJANTA PHARMA LTD 1
ALEMBIC PHARMS LTD 3
ALKEM LABS LTD 2
AUROBINDO PHARMA LTD 22
CIPLA LTD 11
DR REDDYS LABS SA 7
GLAND PHARMA LTD 4
GLENMARK PHARMS LTD 7
GRANULES PHARMS 3
HETERO LABS LTD III 5
JUBILANT GENERICS 2
LAURUS LABS PVT 1
LUPIN LTD 8
MACLEODS PHARMS LTD 4
MICRO LABS LTD INDIA 3
STRIDES PHARMA 12
SUN PHARMA GLOBAL 3
TARO 5
TORRENT PHARMS LTD 3
UNICHEM LABS LTD 1
VIVIMED GLOBAL 2
ZYDUS PHARMS USA INC 16
Indian Companies 125
Total approvals 323

Tentative approvals Jan-June 2018

AJANTA PHARMA LTD 2
ALKEM LABS LTD 1
AUROBINDO PHARMA USA 6
Cipla 2
GLAND PHARMA LTD 1
LUPIN LTD 3
MICRO LABS LTD 2
SUN PHARMA GLOBAL 2
TARO PHARMA USA INC 2
ZYDUS PHARMS USA INC 1
Indian companies 22
Total tentative approvals 71

 

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