Ipca stops API export to US as FDA finds fault at Ratlam unit

Drug firm Ipca Laboratories has voluntarily stopped active pharmaceutical ingredients (API) shipments to the US from its unit at Ratlam following observations of manufacturing norms violations by USFDA investigators.

During the recent US food and Drug Administration (USFDA) inspection at the company's API manufacturing unit at Ratlam in Madhya Pradesh, the company has received certain inspection observations in Form 483 from USFDA, Ipca Laboratories said in a filing to BSE.

"Consequent to this the company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed," it added.

An FDA Form 483 is issued to a firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

As per the USFDA, observations under Form 483 are made when its investigators feel that the "conditions or practises observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health".

Ipca laboratories said the development would have impact on the company's formulations export business to the US market since it's formulations manufacturing units situated at Piparia and SEZ Indore use the APls manufactured from the Ratlam facility for manufacturing formulations for the American market.

The company is fully committed to resolving this issue at the earliest, it added.

Shares of Ipca Laboratories were today trading at Rs 746.50 per scrip in the afternoon trade on BSE, down steep 10.81 per cent from its previous close.