FDA spurns hay fever drug from In­di­a's Glen­mark

In its at­tempt to be trans­par­ent about man­u­fac­tur­ing ma­chin­ery, In­di­an drug­mak­er Glen­mark ap­pears to have shot it­self in the foot with the FDA. On Sat­ur­day, the Ma­ha­rash­tra-based com­pa­ny dis­closed that its hay fever drug, Ryal­tris, had been re­ject­ed by the US health reg­u­la­tor.

In its com­plete re­sponse let­ter, the FDA cit­ed de­fi­cien­cies in the Drug Mas­ter File (DMF) re­lat­ed to one of the ac­tive phar­ma­ceu­ti­cal in­gre­di­ents and a man­u­fac­tur­ing plant, Glen­mark not­ed in a state­ment, adding that it is con­fi­dent the is­sue can be re­solved in the next 6 to 9 months.

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