Ipca Laboratories, a Mumbai-based supplier of active pharmaceutical ingredients and drug products, has voluntarily stopped shipments to the US market from the company’s API facility at Ratlam (Madhya Pradesh) in India following an inspection of the facility and the issuance of a Form 483 from the US Food and Drug Administration. Ipca said it will suspend API shipments from the facility until the issues are addressed.

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 APls manufactured from the company’s Ratlam manufacturing facility for manufacturing formulations for the US market.

Overall, Ipca manufactures 350 formulations and 80 APIs, according to company information.

Source: Ipca Laboratories