Drug maker Ipca Laboratories on Friday said it has received an import alert for its active pharmaceutical ingredients (API) manufacturing facility at Ratlam, Madhya Pradesh, from the US Food and Drug Administration (FDA).
Drug maker Ipca Laboratories on Friday said it has received an import alert for its active pharmaceutical ingredients (API) manufacturing facility at Ratlam, Madhya Pradesh, from the US Food and Drug Administration (FDA).
The company in its filing on BSE on Friday said, "US FDA has issued an import alert to the said manufacturing facility on January 22, 2015."
The facility was inspected last year by the US FDA, which had raised some critical observations in Form 483, following which the company voluntarily decided to temporarily suspended API shipments to the US from the unit July 2014.
Some of the observations were related to laboratory practices along with data integrity in a few cases.
Under Form 483, US FDA communicates certain manufacturing or procedural issues in respect to functioning of a plant and seeks corrective measures. They are inspectional observations, and may or may not lead to an import alert.
According to a research report on Ipca Labs by Morgan Stanley, the Ratlam facility represented roughly Rs 300 crore in sales (formulations + API) to the US market in 2013-14, which is 9% of Ipca sales.
"We believe the import alert will set back the prospects of a recovery in US business (using captive API) by 1-2 years. Abbreviated new drug approvals (ANDAs) filed using API from Ratlam will not get approved until the facility falls back in compliance. We expect remediation cost at Ratlam to rise. Potentially, there could be a collateral damage to its API business from non-US markets as well, in our view," the report said.
However, four APIs – hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim and ondansetron – manufactured at Ratlam unit are excluded from the import alert, the company said.
"Ratlam is the only US FDA approved API plant which is commercialised hence entire US revenues (formulations and APIs) will get impacted due to this voluntary stoppage. Ipca does not have an alternate supplier for its formulations and getting another supplier for its existing formulations will take nearly 1.5-2 years due to regulatory processes involved. Ipca currently has 40 ANDA filings and 18 approvals and markets 8 products in the US," said a pharma analyst.
Ipca has also received a Form 483 at its Indore SEZ, which implies further risks of adverse regulatory action by the FDA.
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