36% of USFDA’s marketing authorizations in 2020 went to Indian drug makers

In what can be considered an indication of the primacy of the Indian pharmaceutical industry, 36% of the total marketing authorizations granted by the United States Food and Drug Administration (USFDA) in 2020 were from manufacturers of Indian medicines.

“This represents 36% of a total of 1,438 marketing authorizations granted by the USFDA in the year 2020 and we can take it as a positive sign that could boost business growth and exports to the US. the future, ”R Uday Bhaskar, director general, The Pharmaceutical Export Promotion Council (Pharmexcil), a branch of the Ministry of Commerce, said Activity area.

ANDA approvals

Marketing authorizations are approvals given to Abbreviated New Drug Applications (ANDAs) that allow companies to bring a product to the US market. Thus, higher marketing authorizations imply better access to the US market and can boost the business performance of individual players as well as the country’s overall exports.

“Not all marketing authorizations may immediately translate into revenue and export growth. It depends on when the product is launched. But it is a crucial step in bringing Indian products to the US market, ” he said.

The number of sites registered with the USFDA for both formulations and bulk drugs in India stands at 741 at present. It also helped drugmakers get ANDA approvals smoothly.

Pharmaceutical exports

The increase in the number of marketing authorizations also contributed to the growth in pharmaceutical exports last year. In FY21, pharmaceutical exports increased 18% to $ 24.4 billion ($ 24,469 million), the highest in the past seven years. In FY20, pharmaceutical exports amounted to $ 20.7 billion.

Industry experts expect better performance for the current year in ANDA approvals. “As the approval of an ANDA after filing takes about a year, those approved last year may not have included many products related to Covid. But this year things could get better as research on products related to Covid-19 and other therapeutic areas has progressed well, ”said the vice president of a listed pharmaceutical company in Hyderabad.

There has been a “good pipeline” from ANDA with leading Indian players who could qualify for First To File (FTF) status in marketing authorizations with exclusive rights for the first six months, which would increase income, he added.

According to industry estimates, oncology and immunology are expected to grow at a high rate of 9-12% over the next five years, while vaccines are expected to grow by 15%.

Currently, India is ranked 10th among the top ten formulations exporting countries and is the 11th largest market. It is expected to be ranked ninth largest market by 2025.

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