1. U-turn by Ipca Labs, says USFDA ban not due to poor manufacturing

U-turn by Ipca Labs, says USFDA ban not due to poor manufacturing

In a volte-face, Ipca Labs said that the USFDA's warning letter involving three of its manufacturing facilities in India was a "withdrawal of exemption" on certain drugs, as the availability shortage situation in the American market has changed.

By: | Published: June 20, 2017 7:06 PM
The company said it got in touch with the US Food and Drug Administration (USFDA) to know the reasons behind the recent issuance of a warning letter to the company’s three plants at Pithampur, Silvassa and Ratlam. (Image: Website)

In a volte-face, Ipca Laboratories today said that the US Food and Drug Administration’s (USFDA) warning letter involving three of its manufacturing facilities in India was a “withdrawal of exemption” on certain drugs, as the availability shortage situation in the American market has changed. Today, shares of the company closed 0.70% higher at Rs 476.00 on the NSE.

The company said it got in touch with the US Food and Drug Administration (USFDA) to know the reasons behind the recent issuance of a warning letter to the company’s three plants at Pithampur, Silvassa and Ratlam.

“USFDA clarified that the reason for issuing these letters is for withdrawal of exemption on certain drugs which was due to the change in drug shortage situation in the US market,” Ipca Laboratories said in a regulatory filing.

The USFDA has not carried out any new inspection or re- inspection of the company’s above manufacturing units, Ipca Labs said. Last year, the USFDA had issued a warning letter to the company over violations of manufacturing norms at the three facilities.Earlier last week, shares of Ipca Laboratories nose-dived around 15.35 per cent to an intraday low of Rs 436.10 on NSE after the company said the US Food and Drugs Administration (USFDA) has refused admission to all drugs made at two of its facilities and all except one drug from another facility of the company. As per a statement by the company at that time, the USFDA had taken the step citing non-adherence of current good manufacturing norms.

Earlier last week, shares of Ipca Laboratories nose-dived around 15.35 per cent to an intraday low of Rs 436.10 on NSE after the company said the US Food and Drugs Administration (USFDA) has refused admission to all drugs made at two of its facilities and all except one drug from another facility of the company. As per a statement by the company at that time, the USFDA had taken the step citing non-adherence of current good manufacturing norms.

The ban on all drugs made at Pithampur (Madhya Pradesh) and Silvassa (Dadra and Nagar Haveli) will continue “until the company can demonstrate that the drugs manufactured from these manufacturing sites and intended for the US market are in compliance with the current good manufacturing practice regulation (CGMP),” IPCA Laboratories had said in a statement.

All drugs except API Chloroquine Phosphate made at Ratlam (Madhya Pradesh) unit have also been denied entry in the US, it further said. However, it said the US health regulator will reconsider the exception for Chloroquine Phosphate made at the Ratlam facility if shortage and/or medical necessity implications change.

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