IPCA Laboratories halts operations at formulations manufacturing unit in MP

08 Nov 2012 Evaluate

IPCA Laboratories has decided that it will not manufacture any dosage formulations at its oral solid dosage formulations manufacturing facility situated at Pharmazone, SEZ Indore, Pithampur in Madhya Pradesh and the dosage will not be commercialized for the US market. The company had received the USFDA approval in July this year for the above manufacturing unit.

The company has taken this step as during the course of the internal quality assurance review it had noticed a few non-conformances at the said manufacturing unit. The company has voluntarily referred these to the US Food and Drug Administration (USFDA) and the same is under discussion with them for an appropriate resolution. So till the time issue is resolved to the satisfaction of the USFDA the company will not commence operations.

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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