NEW DELHI :
The US Food and Drug Administration has issued a warning letter to Glenmark Pharmaceutical Ltd’s manufacturing plant in Baddi, Himachal Pradesh, the company said in a filing with the exchanges.
The warning letter follows adverse observations made by the regulator during an inspection in April, and, usually, new product approvals are not granted for the plant even as existing imports from the unit are allowed.
However, the company said that it does not expect a significant financial hit from the warning letter, as there are no major pending product approvals from the facility in the next 12 months.
“We believe that the existing manufacturing and the sale of products from this facility will not be impacted. The Baddi facility is expected to contribute USD 30 mn in total sales for this financial year, which is approximately 7% of the total US sales," Glenmark said in the filing.
In the June quarter, formulation sales to the US garnered Rs7.3 billion in revenue, nearly a third of its total consolidated topline Rs23.2 billion.
The Baddi facility manufactures solid and liquid oral drugs, topical medicines like lotions and creams and respiratory segment products, as per information on the company’s website.
The US FDA had issued adverse observations after an inspection in April, and classified them as ‘official action indicated’ (OAI), the company had disclosed after its June quarter earnings earnings.
The regulator classifies its observations as OAI when it believes that objectionable conditions or practices need urgent remedial measures.
Apart from the plant at Baddi, none of its eight USFDA-approved manufacturing facilities Glenmark currently has eight manufacturing facilities--five formulations facilities and three API facilities--have any outstanding issues with the regulator as of now, the company said.