The world body, in its inspection from 26-30 October, found data integrity issues at the plant that manufactures Lyssavac-N, an anti-rabies vaccine
Hyderabad: Drug maker Cadila Healthcare Ltd on Tuesday said it has received a Notice of Concern (NoC) or warning from the World Health Organisation (WHO) for violations of good manufacturing practices at its vaccine plant in Moraiya in Sanand district of Gujarat.
The world body, in its inspection from 26-30 October, found data integrity issues at the plant that manufactures Lyssavac-N, an anti-rabies vaccine.
The vaccine plant is located in the vicinity of the formulation facility that received a US Food and Drug Administration (FDA) warning letter on 31 December over non-compliance with manufacturing standards.
Cadila said it has responded to WHO and has been implementing remedial measures. “There is no significant impact on the business and there were no exports of this product to the US," the company clarified.
Cadila stopped production, initiated an internal investigation and made a voluntary recall of all the batches of Lyssavac-N made after April 2015, from when the investigation revealed that the issues started.
The company has also informed WHO that the manufacturing activities for vaccines and biologicals at this site will only resume after acceptable corrective and preventive actions (CAPAs) have been submitted, assessed and confirmed through an on-site inspection.
Cadila has got WHO approval to sell Lyssavac-N to United Nations agencies. The vaccine is marketed in India under the brand name Vaxirab.
WHO issues such warnings when it finds violations of good manufacturing practices at a site that produces products prequalified by it.
An NoC may withhold pre-qualification of all new products manufactured at the site until observations have been satisfactorily addressed. Failure to do so within a reasonable time frame may lead to suspension of procurements of all prequalified products made at the site.
Shares of Cadila dropped 5.29% to close at ₹ 323.20 on the BSE, while the benchmark Sensex gained 0.18% to end 25330.49 points.
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