IPCA Laboratories receives USFDA acceptance for formulations manufacturing unit in MP

04 Sep 2013 Evaluate

IPCA Laboratories has received the US Food and Drug Administration (USFDA) acceptance for its oral solid dosage formulations manufacturing facility situated at Pharmazone, SEZ Indore, Pithampur in state of Madhya Pradesh. This will enable the company to commercialize oral solid dosage formulations in the US market from this formulations manufacturing facility.

Last year in November, the company had decided that it will not manufacture any dosage formulations at its oral solid dosage formulations manufacturing facility and the dosage will not be commercialized for the US market. The company had 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 had voluntarily referred these to the USFDA and the same was under discussion with them for an appropriate resolution.

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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