Indoco Remedies Baddi facility gets GMP certification from EU Health Authority

Published On 2023-07-26 06:07 GMT   |   Update On 2023-07-26 06:07 GMT
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Mumbai: Indoco Remedies has received EU GMP certification from the Competent Health Authority of Malta for its manufacturing site in Baddi (Unit -I) located at Village Katha, Tehsil- Nalagarh, District– Solan, Himachal Pradesh.

The Agency had conducted an inspection at Indoco’s manufacturing facility for solid oral dosage form from April 20 - 24, 2023.

The EU GMP certification issued by the Health Authority from Malta confirms that the site complies with the f Good Manufacturing Practice requirements as referred in the EC Directive. The EU GMP certification will support supplies of drug products to Europe and other territories 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 (Unit I), further builds upon our capability as an organization to supply quality and affordable medicines in Europe and other geographies. We are committed to remain cGMP compliant and ensure supplying quality products to our customers and patients across globe."

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. 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.
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