IPCA Laboratories has reportedly got US Food and Drug Administration (USFDA) import alert for Ratlam plant in Madhya Pradesh due to violations of standard production practices.
FDA had issued Form 483 to Ratlam API in mid 2014. In form 483s, FDA pointed out data integrity issues at Ratlam plant. Ratlam is the only USFDA approved API plant and thus US revenues will get impacted following the alert.
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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Friday 23 January 2015
IPCA Laboratories gets USFDA import alert for Ratlam plant: Report
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