Ipca Labs receives 3 USFDA observations for Tarapur facility
Mumbai: Ipca Labs has announced that the U.S. Food and Drug Administration (USFDA) has concluded inspection with three observations at the Company’s Active Pharmaceutical Ingredients (APIs) manufacturing facility situated at Tarapur (Palghar Maharashtra).
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Established in 1949, lpca is a pharmaceutical company. lpca is vertically integrated and produces finished dosage forms and active pharmaceutical ingredients. For more than 70 years, lpca has been a crucial healthcare partner in over 120 countries across the globe. lpca markets its branded formulations in India and rest of the world markets and generic formulations in United States, Europe, United Kingdom, Canada, Australia & New Zealand. APls manufactured by lpca are marketed across the globe.
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