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Indoco Remedies Limited announced today the successful completion of a routine inspection by the United States Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredients (API) manufacturing facility located in Patalganga, Navi Mumbai. Notably, the inspection concluded with zero Form 483 observations, a rare and significant achievement in the pharmaceutical manufacturing sector.
This outcome reflects Indoco’s robust quality systems, regulatory compliance, and operational excellence. A Form 483 is issued by the USFDA when investigators observe any conditions that may violate the Food Drug and Cosmetic (FD&C) Act. A “zero observation” inspection result indicates full compliance with applicable regulations.
“This successful USFDA inspection is a testament to the strong quality culture and compliance in every process and every product,” said Ms. Aditi Panandikar, Managing Director of Indoco Remedies Limited. “We remain committed to strengthening our systems to deliver safe and efficacious medicines across the globe.”
Strong Foundation in Quality and Innovation
Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a strong domestic and international footprint. With 11 manufacturing facilities — including 4 dedicated to APIs and 7 for finished dosage forms (FDFs) — the company’s production infrastructure is backed by a state-of-the-art R&D centre and a Contract Research Organization (CRO) facility. These sites have received approvals from leading global regulatory bodies, including the USFDA and the UK-MHRA.
The company boasts a turnover of USD 180 million and employs more than 6,000 professionals, including over 400 scientists and field staff.
Expanding Global Presence
Indoco manufactures a wide range of pharmaceutical products for both the Indian and international markets. Its domestic operations are powered by 10 marketing divisions and a robust product portfolio across therapeutic areas such as gastrointestinal, respiratory, anti-infectives, ophthalmology, cardiology, diabetology, pain management, and gynaecology.
The company’s key brands — including Cyclopam, Febrex Plus, Sensodent-K, Glychek, MCBM 69, and Rexidin — are well recognized in the Indian market, contributing to over 106 million prescriptions annually from more than 240,000 doctors.
Indoco also has established partnerships with leading global generic pharmaceutical companies, further expanding its footprint in regulated markets across the world.
About Indoco Remedies Limited:
Indoco Remedies Limited is a Mumbai-based pharmaceutical company known for its commitment to innovation, quality, and healthcare excellence. With a diverse product portfolio and a focus on research and compliance, Indoco is positioned as a trusted partner in the global pharmaceutical landscape.
