Glenmark Pharmaceuticals Ltd. received a warning letter from the U.S. Food and Drug Administration for its Baddi facility in Himachal Pradesh.
The company is committed to working along with the regulator to implement all the necessary corrective actions required to address the concerns raised in the letter, the Glenn Saldanha-led company said in an exchange filing, adding that it does not see any financial impact on account of the development.
We believe that the existing manufacturing and the sale of products from this facility will not be impacted. There are no major pending approvals from this facility in the next 12 months.Glenmark Pharmaceuticals' Exchange Filing
The company, however, added that the Baddi facility is expected to contribute $30 million in total sales this financial year, or approximately 7 percent of total U.S. sales.
The FDA warning letter could lead to lower volume and revenue contribution from exports to the U.S. in the ongoing financial year, as the focus will be on remediation work, Prabhudas Lilladher analyst Surjit Pal to BloombergQuint. “Besides additional caution before sending batches to the U.S. will also slow down production.”
Glenmark Pharmaceuticals mainly produces oral solids, liquids, lotions, and ointments for skin and respiratory ailments at the Baddi unit.
The warning letter followed an FDA inspection of the facility between April 15 and April 20, after which the regulator issued a Form 483 with eight observations.
The company said that it is in the process of preparing a detailed response to the FDA within 15 working days.
The company has eight manufacturing plants - five formulations units and three Active Pharmaceutical Ingredient facilities - approved by the FDA, and none of these units except Baddi has any outstanding issues, the Mumbai-based company said.
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