Indoco Remedies Baddi facility bags EU GMP certification from Health Authority of Germany

The EU GMP certification issued by the German Health Authority (Berlin) confirms that the site complies with the Good Manufacturing Practice requirements as referred in the EC Directive.

Published On 2023-06-09 10:09 GMT   |   Update On 2023-06-09 10:09 GMT
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Mumbai: Pharma firm, Indoco Remedies, has announced that the company has received EU GMP certification from the Competent Health Authority of Germany for its manufacturing site situated at HB 211 Village Katha, IN- 173 205 Baddi, Tehsil- Nalagarh, District - Solan.

The Agency conducted an inspection at Indoco’s manufacturing facility for oral dosage form (Baddi -III), from May 22 - 25, 2023.

The EU GMP certification issued by the German Health Authority (Berlin) confirms that the site complies with the Good Manufacturing Practice requirements as referred in the EC Directive. The EU certification will support supplies of drug products registered in Europe, from this manufacturing site.

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Commenting on the development, Ms. Aditi Panandikar, Managing Director – Indoco Remedies Ltd., said that "The EU GMP certification for our site in Baddi adds to our consistent efforts to supply quality and affordable medicines in Europe. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the globe."

Read also: Indoco Remedies acquires 85 percent equity stake of FPP Holding for over Rs 33 crore from Contract Pharmacal Corp.

Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. The Company’s turnover is US$ 200 million.The Company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 109 million prescriptions annually from over 3,00,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM 69, Methycal, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.

Read also: Indoco Remedies AnaCipher CRO gets clearance on Remote Record Assessment from USFDA

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