Cadila clarifies US regulatory warning on Gujarat units

Ahmedabad, Dec 31 (IANS) Pharma major Cadila Healthcare on Thursday clarified that products from its Moraiya and Ahmedabad plants in Gujarat were safe in the market and effective.

“We take quality and compliance issues seriously and standby our commitment to comply with CGMP quality standards across our plants,” the city-based Cadila said in a regulatory filing to the Bombay Stock Exchange (BSE).

The company’s clarification came in response to a warning letter issued recently by the US Food and Drug Administration (FDA) on its formulation facility at Moraiya and API facility (Zyfine).

“We hereby clarify that there are no products in the US market which use API (active pharmaceutical ingredients) or Zyfine facility,” the statement said.

Committing to supply quality products to customers worldwide, the drug maker said it would respond to the watchdog’s warning and observations within the statutory time granted.

“As we are committed to resolve all issues, we will continue to take steps to ensure the US regulator is satisfied with our remediation of the two units under watch,” the filing added.

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