The share of Indian pharmaceutical companies account for 39% of the total number of FDA approvals
India holds an important place in the global pharmaceutical sector. Indian R & D-oriented pharmaceutical companies and their subsidiaries received a large number of approved applications for the Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA).
According to the Pharmabiz study, in the first half of the year (including June 2018), Indian pharmaceutical companies and their subsidiaries received 125 final ANDA approvals out of a total of 323 approvals. Thus, Indian companies accounted for about 39% of the total number of allegations. Similarly, these companies received 22 preliminary approvals (tentative approvals) out of a total of 71 provided by the FDA for this period.
In the first half of 2018, the level of approval was slightly lower compared to the same period in 2017, when the FDA approved a total of 387 applications and issued 85 preliminary approvals. Of these, 137 ANDA statements and 32 preliminary approvals were received by Indian companies.
According to the Pharmabiz study, Aurobindo Pharma is the leader among Indian companies, having received 22 ANDA endorsements. It is followed by Zydus Pharma – 16 approvals, Strides Shasun – 12, Cipla – 11. Lupin, Sun Pharma Global and Taro Pharma also received 8 statements each. This is followed by Dr. Reddy’s Laboratories and Glenmark Pharmaceuticals, each of which received 7 approvals in the first half of 2018. In addition, Aurobindo Pharma also became the leader in the number of preliminary approvals during the first half of this year.
During the 2017-2018 fiscal year, R & D expenses of Aurobindo increased to 91 million dollars. US and accounted for 4% of the company’s revenues (2.248 billion dollars), while sales in the United States increased to 1014 million dollars. in 2018, Lupin, India’s third largest pharmaceutical giant, incurred R & D costs of $ 252 million. during 2017–2018, which corresponds to 11.9% of sales. Dr. Reddy’s Laboratories spent $ 249 million on R & D. in 2017–2018 compared to 266 million dollars. for the previous year, which is 7% less.
Despite fierce competition, Indian pharmaceutical companies continue to grow rapidly. But, according to a Pharmabiz study, there is also a tendency to reduce the cost of R & D by some large companies, which may adversely affect the high rating indicators of Indian companies relative to ANDA. According to analysts, these companies should reverse the trend and invest more in R & D.