Monday, April 20, 2009

US FDA finds glitches in Cipla's Goa, Bangalore plants

The US-Food and Drug Administration (FDA) has found nine deviations at pharmaceutical company Cipla's Banglore plant. Cipla, in response, said the deviations were of a routine minor nature. "The US-FDA's findings suggest need for improvements in good manufacturing practices.” CNBC-TV18's Archi Damania reports.
“The FDA has merely pointed out deviations, which happen even with the case of global majors,” Cipla said. The FDA has, however, said, “If Cipla fails to address the issues, it could invite a warning letter, followed by harsher action.”
US sales of Cipla are not very large—they are about 10% of the total sales.
However, what is important here is that significant amount of revenues of Cipla comes from Africa and that has high presence in the Human Immunodeficiency Virus (HIV) ie anti-AIDS segment, which contributes about 17%. To get approval from the President's Emergency Plan for AIDS Relief (PEPFAR), which is the President’s funds for antiretroviral disease, Cipla needs to have US-FDA approvals on and it needs to be in good books of US-FDA.
Reports also say that Cipla opposed the Cipla MedPro takeover by Adcock. The company may stop supplies to Cipla Medpro in South Africa.
Adcock had earlier announced that it wants to acquire Cipla MedPro in South Africa.
Adcok, however, had said they would continue supply from Cipla. Cipla has no Holding in Cipla Medpro but has 20-year supply agreement. The drug-supply agreement allows Cipla to terminate the supply programme if there is a change in the management.
If Cipla opposes this or if it doesn’t get through and if it cancels the supply agreement then the revenues from South Africa from its supplies to Cipla Medpro could also be impacted.

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