Indoco Remedies Shares Rally 4% on Securing EIR from USFDA 

Shares of Indoco Remedies Ltd rallied 4% on 12 December after the company announced receiving an Establishment Inspection Report (EIR) from the US Food and Drug Administration. 

The company has received the EIR for its Patalganga-based Active Pharmaceutical Ingredients (API) production plant, following a successful inspection from September 15, 2025 to September 19, 2025.

Aditi Panandikar, managing director of 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.”

An EIR is a detailed official report provided by the US FDA following an inspection of a drug manufacturing plant. It describes the inspection scope, findings, evidence gathered, company responses, and FDA conclusions in significantly greater detail than the Form 483 observations issued on-site. 

Pharma companies and investors pay particular attention to EIRs because they indicate remediation needs, compliance risks, and timetables, all of which have a direct impact on product approvals, site status (NAI/VAI/OAI), and stock sentiment.

Indoco Remedies is a fully integrated, research-oriented pharmaceutical firm that manufactures and markets formulations (finished dosage forms) and APIs. It has a seven-decade history in the Indian pharmaceutical sector and a strong presence in 55 countries worldwide.

The company operates 11 production facilities, seven for finished doses and four for APIs, and is supported by a research and development (R&D) center in Rabale, Navi Mumbai, and a clinical research organization in Hyderabad. Its manufacturing facilities meet the highest regulatory requirements, including WHO-cGMP recommendations, and have been approved by numerous regulatory bodies such as the USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TMDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, and so on.

At 12:44 pm, the shares of Indoco Remedies were trading 0.58% higher at Rs 240.85 on NSE.

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