Cadila gains 4% as US FDA revokes warning on unit

The warning was issued in June 2011, saying the facilities in the plant were not conforming to the US FDA guidelines and that there were fears the company's drugs from the unit may get adulterated.

FP Staff July 17, 2012 12:54:22 IST
Cadila gains 4% as US FDA revokes warning on unit

Shares of Cadila Healthcare were up more than 4 percent after the company informed the stock exchange that the US Food and Drug Administration (FDA) has revoked a warning letter issued to its plant in Moraiya, Gujarat.

The stock was at Rs 830.

The warning was issued in June 2011, saying the facilities in the plant were not conforming to the US FDA guidelines and that there were fears the company's drugs from the unit may get adulterated.

Cadila gains 4 as US FDA revokes warning on unit

AFP

"We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates. Additionally, there is no assurance that such errors have not occurred previously (during the manufacture of exhibit batches for application products pending with FDA)."

The letter also said the plant was not adequately sterilised and the staff who carry out critical operations were not monitored properly.

It has also warned that the company may be barred from selling drugs manufactured from the plant if it did not take corrective measures.

Updated Date:

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