Ipca Laboratories has voluntarily decided to temporarily suspend API shipments from its manufacturing facility to the US markets untill USFDA issue is addressed. The said facility is situated at Ratlam in state of Madhya Pradesh. Ipca has taken this step as during the recent USFDA inspection at the said facility, the company has received certain inspection observations in Form 483 from the USFDA.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have impact on the company’s formulations export business to the US market since the company’s formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APIs manufactured from the company’s Ratlam manufacturing facility for manufacturing formulations for the US market.
Further, 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.
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