Ipca Voluntarily Halts Shipments from its API Manufacturing Facility for the US Markets
Ipca Laboratories has intiated a voluntary stoppage of shipments from the company's active pharmaceutical Ingredients (APls) manufacturing facility situated at Ratlam (Madhya Pradesh) for the US markets.
During the recent US FDA inspection at the company's APls manufacturing facility situated at Ratlam (Madhya Pradesh) the company has received certain inspection observations in Form 483 from tFDA.
Consequent to this, Ipca Laboratories has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed.
This voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also affect 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.
The company says it is fully committed in resolving the issue as soon as possible; it is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture.
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