Indoco Passes USFDA Inspection with Zero Observations

Indoco is a pharmaceutical company with a large global presence that is completely integrated and focused on research. With a human capital of over 6000 personnel, including over 400 highly qualified scientists and field workers who represent the organization's backbone, the company generates USD 180 million in revenue annually.The United States Food and Drug Administration (USFDA) has successfully inspected Indoco Remedies Limited's manufacturing plant for Active Pharmaceutical Ingredients (API) in Patalganga, Navi Mumbai. The company's dedication to the highest levels of quality, regulatory compliance, and operational excellence is demonstrated by the inspection's zero form 483 observations at the end.

“This successful USFDA inspection is a testament to the strong quality culture and compliance in every process and every product. We remain committed to strengthening our systems to deliver safe and efficacious medicines across the globe,” said Ms. Aditi Panandikar, Managing Director, Indoco Remedies Limited.

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Indoco Remedies Ltd., is a fully integrated, Science-led pharma company engaged in manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). We have seven decades of presence in the Indian Pharma market and a firm presence in international markets across 55 countries. Indoco is a US$ 180 million company with around 6000 people including over 400 skilled scientists.

We operate 11 manufacturing plants, 7 of which are finished dosage forms and 4 are APIs, along with a modern R&D centre at Rabale, Navi Mumbai and a Clinical Research Organisation at Hyderabad. Our state-of-the-art manufacturing plants are of the highest regulatory standards, complying with WHO-cGMP and approved by many regulatory authorities including, USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TMDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, etc.