Indian Generics Companies in the US Snapshot

The US generics market stood at USD 69 billion in 2018 and is expected to grow to USD 86 billion by 2022.

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Abbreviated New Drug Applications (ANDAs), whereby a company seeks authorisation from the US FDA for a generic copy of a previously approved drug, are on the rise. At the forefront of this trend are major Indian pharma players such as Cipla, Zydus Cadila, Dr. Reddy’s, and Sun Pharma, which are making up an increasingly large share of overall applications.

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As India has the highest number of US FDA-approved finished dosage facilities of any nation on earth – over 200 – the FDA has ramped up the number of inspections being carried out at Indian facilities.

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