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Cadila Healthcare largest API manufacturing site clears USFDA inspection


Cadila Healthcare largest API manufacturing site clears USFDA inspection

The US Food and Drug Administration (USFDA) inspected the company’s active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from October 7 to October 11, 2019, Cadila Healthcare said in a statement.

New Delhi: Drug firm Cadila Healthcare on Friday said the US health regulator issued no observations after the inspection of its Dabhasa facility in Gujarat.

The US Food and Drug Administration (USFDA) inspected the company’s active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from October 7 to October 11, 2019, Cadila Healthcare said in a statement.

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Also Read: Cadila Healthcare gets OAI letter from USFDA for Moraiya facility

Dabhasa facility is the company’s largest API manufacturing site, it added.

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“This was a current good manufacturing practice (cGMP) audit and a pre-approval inspection (PAI). At the end of the inspection, no observation (483) is issued,” Cadila Healthcare said.

Headquartered at Ahmedabad, Cadila’s Dabhasa plant API/Bulk Drug Plant in a village about 20 kilometres South from Vadodara houses one of the largest process research (API) centres in that country. This plant belonged to Banyan Chemicals which was acquired by Zydus in 2003.

Also Read: Cadila Healthcare to sell right of cholesterol-lowering drug Zypitamag for Rs 49 crore


Source: with inputs
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