Drug maker Lupin’s Tarapur active pharmaceutical ingredient (API) plant has got four observations from the US Food and Drug Administration (USFDA). The company has been issued Form 483 for the facility, which was inspected between March 22 and April 4.
The Form 483 is issued by USFDA to a company after an inspection if the investigation concludes with any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The Form 483, which has been accessed by CNBC-TV18, has also noted that the cleaning process has not been adequately established and validated while another observation is that the investigations have been inadequate.
The inspection at the facility in Maharashtra concluded that the existing procedures and processes for manufacturing APIs were inadequate. The Tarapur plant has an official action indicated (OAI) status pending from the USFDA, which was issued to it in January 2020. OAI means that regulatory/ administrative actions will be recommended by the US drug regulator. Another observation was related to not establishing process sampling and controls.
Meanwhile, Drug firm Lupin on Monday said it has got approval from the US Food and Drug Administration to market Tenofovir Alafenamide tablets, used to treat chronic hepatitis B virus infection, in the American market.
The Mumbai-based company has received tentative approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application for Tenofovir Alafenamide tablets (25 mg), Lupin said in a statement. The company’s product is the generic equivalent of Gilead Sciences’ Vemlidy tablets, it added.
Lupin has 15 manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognised as a ‘Great Place to Work’ in the biotechnology and pharmaceuticals sector, it said.
Earlier this month, Lupin also said its new Jersey facility had received 13 observations from the US drug regulator. The facility accounts for less than five per cent Lupin’s global turnover. The observations do not, however, imply any restriction on supplies.
The company had said in a statement to stock exchanges: “US FDA inspection of the company’s Somerset, New Jersey (US) facility. The USFDA has concluded an inspection at the company’s wholly-owned subsidiary Novel Laboratories, Inc., based in Somerset, NJ. The inspection commenced on March 7, 2022, and concluded on March 30, 2022. The inspection closed with thirteen observations.”
However, it added that the company is confident to address these observations and will work closely with the Agency to address their concerns. “We uphold quality and compliance with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all our facilities.”
The company claimed this would not have any impact on the supplies or existing revenues from operations of this facility.
Lupin’s shares on Monday closed at Rs 771.45 apiece, a decline of 0.12 per cent as compared with the previous close.
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