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Our Bureau, Mumbai January 02 , 2021
The Indian pharmaceutical companies will benefit from an improving demand from the US market, as they have garnered 45 per cent of all new ANDA (abbreviated new drug application) approvals over the past nine months, stated India Ratings and Research.

The agency expects the regulatory environment to remain stringent, and the well-equipped companies will be able to take the advantage of a better pricing outlook emanating from supply shortages and recalls.

Indian companies have received a higher share of new ANDA approvals since April 2020, led by significant manufacturing facility clearances, GDUFA II (Generic Drug User Fee Amendments), and a strong filing momentum, aided by historical investments in research & development, the agency said.

"The majority of the drug recalls (91%) from the US markets are from the non or least serious category (Class II and III recalls). However, only Class I drug recalls are serious in nature. Out of the total inspections, Indian pharma companies have received average 11% OAI (official action indicated) status. Indian companies have received three of the seven warning letters issued since August 2020," the rating agency said.

India Ratings has seen an increasing drug demand since the start of pandemic, led by supply chain issues, channel filling and demand for COVID-19 led preventive products.

The agency added, “In the past too, there was drug shortages in the US because of the exit of the large generic players from unviable products. Overall, drugs shortages in the US are leading to moderate-to-stable pricing pressures.”

The agency also believes US Food and Drug Administration (FDA) inspection and related scrutiny is a part and parcel of the industry.

“Despite having the second-largest number US FDA approved plants (active pharmaceuticals ingredients and formulations), India has faced average of just 9% of the total US FDA inspections globally over the past 12 years,” the agency said.

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