Ipca Laboratories has received warning letter from US Food and Drug Administration (FDA) for its manufacturing units in Ratlam (Madhva Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa) manufacturing units.
The company has already voluntarily suspended shipments of its APIs and formulations for the US market till US FDA inspection observations are resolved. Therefore, since July 2014 the company has not shipped any APls or formulations to US market except the products which are exempted from import alert.
The company has responded to the US FDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner.
Since the inspection, the company has regularly communicated with US FDA with periodic updates on remedial measures undertaken. The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture.
Ipca Laboratories is engaged in manufacturing of active pharmaceutical ingredients and formulations. It operates in 110 countries and its export accounts for 50% of the company’s income. Worldwide the company is one of the largest suppliers of APIs and intermediates. The company holds leadership position in Anti-malarial and Rheumatoid Arthritis area.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1850.40 |
| Dr. Reddys Lab | 1310.50 |
| Cipla | 1365.25 |
| Zydus Lifesciences | 939.10 |
| Lupin | 2442.35 |
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