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Ajanta Pharma's Paithan facility gets US FDA 483 observation

Our Bureau, MumbaiThursday, February 9, 2017, 14:35 Hrs  [IST]

Ajanta Pharma, a Rs.1,700 crore plus pharma major from Mumbai, has received one procedural related US FDA 483 observation regarding its Paithan facility. Earlier on January 24, the company management denied the news that it received import alert. The company is in process of responding to the same within the stipulated time prescribed by US FDA.

Despite US FDA observations, Ajanta scrip moved forward by over 2.7 per cent or Rs.46.85 to Rs.1,805.95 in the afternoon session on BSE.

The US market will be a key growth driver in the coming year. The company is strengthening its capabilities in R&D and manufacturing. It has 8 final products approved and 2 tentative approvals from the US FDA. The company is planning to file 8-12 ANDAs every year.

 
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