US FDA Issues 5 Observations To Granules India's US Subsidiary

The U.S. Food & Drug Administration has issued five observations to Granules Pharmaceuticals, Inc., a wholly-owned U.S.-based subsidiary of Granules India after an inspection, the latter said in a notification to the stock exchanges on Saturday.

The Good Manufacturing Practice inspections occurred between Dec. 11 and Dec. 15.

The filing also said that the company plans to address these observations within the designated timeframe and does not foresee any impact on its operations. The nature of the observations was not disclosed.

Granules India has seven manufacturing facilities out of which six are located in India and one in Virginia in the US.

Earlier this week, Granules India announced that the US FDA has approved its Abbreviated New Drug Application for Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg and 40 mg.

Granules now has a total of 64 ANDA approvals from the US FDA, including 62 final approvals and two tentative approvals.

Shares of Granules India ended higher by close to a percent on Friday at Rs 390.40 apiece on the National Stock Exchange.