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RECORD ANDAs FROM US FDA

Ramesh Shankar
Wednesday, February 7, 2018, 08:00 Hrs  [IST]

Indian R&D-based pharmaceutical companies and their subsidiaries have received an all time high final abbreviated new drug application approvals from US FDA during the year 2017 to launch generic drugs in the US drug market. The clearances came despite regulatory pressures from the US FDA, and unprecedented number of warning letters issued to the Indian pharma companies' facilities by the US FDA. According to a Pharmabiz study, Indian pharmaceutical companies and their subsidiaries received a record number of 304 final ANDA approvals from US FDA during the year 2017 as compared to 201 ANDA approvals in the previous year. The US FDA approved a total of 846 ANDAs during 2017 which remained highest during the last one decade. Indian companies with enhanced R&D investments during the last couple of years managed to secure almost 36 per cent of total approvals by US FDA. Moreover, the US FDA approved 171 tentative approvals and out of this Indian companies grabbed 61 tentative approvals in 2017. During the last one decade from 2008-2017, the US FDA approved a total of 5,020 ANDAs and 1184 tentative approvals. Out of this, Indian companies bagged 1,695 ANDA approvals and 455 tentative approvals. The average rate of securing approvals by Indian pharma companies worked out to almost 34 per cent for the last one decade. As per the study, Cadila Healthcare and its US based subsidiary remained on top in securing highest number of approvals in 2017 with 71 ANDAs, followed by Aurobindo Pharma (51), Sun Pharma & Taro Pharma (21) Glenmark (18), Gland Pharma (16), Alkem Laboratories (15), Macleods Pharma (15), Lupin (13), and Cipla and Dr Reddy's Laboratories 10 each. Further, Strides Shashun and Alembic Pharma received 9 ANDA approvals each from US FDA during the year 2017. Besides these companies, Jubilant Lifesciences, Ajanta Pharma, Micro Labs, Unichem Laboratories, Torrent Pharma, Natco Pharma, Orchid Pharma, Panacea Biotec, Granules India, Hetero Labs, Intas Pharma, Marksans Pharma and Vintage Pharma also received ANDA approvals from US FDA in 2017.

The Indian companies' feat on ANDA approvals is commendable given the fact that the Indian pharma majors, including Sun Pharma and Dr Reddy's, faced tremendous quality issues during the last couple of years raised by US FDA and got warning letters as well as ban on exports. The highly lucrative, around $70-billion, US market is a key growth driver for Indian pharma companies and actions or ban on Indian products would adversely impact working and share price movements of these companies. And it is a fact that several Indian pharma giants suffered heavily during the last one year due to the US FDA actions. But, these companies did not waste time in taking steps to overcome these obstacles and invested higher funds in research activities. Higher investment in R&D helped them to secure higher number of product approvals. The pharma companies should invest more on R&D to keep this trend going.

 

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pradeep awasthi Feb 11, 2018 6:39 PM
The last two years has witnessed massive set back to the Indian pharma landscape in terns of net profit and growth,due to major export of generics which has been kept on hold of big pharm gisnts,Sun pharma,Dr reddy and lupin labs,due to the insufficient qualities of generics which are exported to U.S.There is no doubt to the fact that R and D builts the foundation of manufacturing quality of generics.

The most recent change in scenario of Indian pharma companies like Sun,reddy and cadilla in terms of high percentage of generic approval,contribute to its extraordinary and smart R and D facilities in manufacturing superior quality of generic drugs.The Indian export of generic is contributing to 40% of its total yearly turnover.Therefore it is imperative that Indian pharma companies should think of higher investment in R and D to keep up their pace in export of generics.
 
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