Gujarat-based Zydus Cadila has said that it was responding to a product-specific observation made by the United States Food and Drug Administration.
Though the development comes against the backdrop of a spate of US regulatory directives involving India-based companies, Zydus clarified that the US FDA observation was not related to its manufacturing operations.
“This was a product specific review and the inspection was limited to the review of documents for filed ANDA (abbreviated new drug application) before its approval and the observations are being responded to. There are no GMP (Good Manufacturing Practices) related issues and as such no business impact,” a note from Zydus said.
Companies file an ANDA when they look to sell a product in the US.
The product and plant from where it would be exported to the US are then inspected.
“The company has not received any GMP observations from the US FDA for its current operations at its Moraiya plant.
“The GMP audit for the Moraiya manufacturing plant happened in August 2013 which has been cleared,” Zydus added.
When the FDA inspects a plant, it makes regulatory observations on aspects it needs corrected on the 483 form. A company is off the hook if it’s response on corrective actions are acceptable to the FDA.
If the regulator is not convinced, the issue could escalate to getting a warning letter from the USFDA or a ban on imports in the US on products from the said plant.
Last week, IPCA had voluntarily stopped exporting pharmaceutical ingredients made at its Madhya Pradesh-based plant, following a 483 regulatory observation on its Ratlam plant.
And this came even as multiple Ranbaxy and Wockhardt plants face intense USFDA scrutiny.