Indoco Remedies Gets USFDA EIR for Patalganga API Facility

Indoco Remedies Limited has received a key regulatory clearance from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredients operations, strengthening its position in the global pharmaceutical supply chain.

The company confirmed that it has been issued the Establishment Inspection Report (EIR) for its API manufacturing facility located at Patalganga, Maharashtra.

The EIR follows a successful inspection conducted by the USFDA at the Patalganga site from September 15, 2025, to September 19, 2025. The inspection covered manufacturing processes, quality systems, and compliance standards required for supplying APIs to the U.S. market. Receipt of the EIR indicates that the regulator has completed its review and found the facility to be in line with applicable regulatory expectations.

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For Indoco Remedies Limited, the EIR marks an important regulatory milestone. The Patalganga API facility plays a critical role in the company’s backward integration strategy and supports both domestic formulations and regulated market exports. Regulatory clearance from the USFDA helps ensure continuity of supplies to customers in the United States and other regulated markets that rely on U.S. standards as a benchmark.

Commenting on the development, Aditi Panandikar, Managing Director, Indoco said, "We are pleased to have received the EIR from the USFDA for our API manufacturing facility located at Patalganga. This further reinforces our commitment to upholding the highest standards of quality and compliance, delivering trusted healthcare solutions to patients worldwide."

The EIR strengthens Indoco’s regulatory track record and supports its long-term growth plans in regulated markets. With this clearance, Indoco Remedies Limited continues to build credibility as a reliable manufacturer focused on quality, compliance, and sustainable operations.