Drug firm Zydus Cadila today said its manufacturing facility at Moraiya in Ahmedabad has received an Establishment Inspection Report (EIR) from the US health regulator.
The manufacturing plant had completed the US Food and Drug Administration (USFDA) audit from February 6-15, 2017 with zero Form 483 observations, Zydus Cadila said in a statement.
As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company's management of objectionable conditions.
Post the audit, the plant has received several product approvals, including the final approval to market mesalamine delayed-release tablets in the American market, it added.
The EIR is issued by the FDA only if it finds the facility to be deemed acceptable.
The USFDA releases a copy of the EIR to the entity that is the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
Shares of Cadila Healthcare were trading 0.54 per cent down at Rs 520.95 on the BSE.
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