UK drug regulator MHRA reinstates full GMP status to Indoco Goa Plant I

UK-MHRA conducted a ‘Focused Audit’ in October 2018 and GMP audit in May 2019. These audits were completed with no Critical Observations and Indoco has now received a full GMP status for its Goa Plant I. The revenues from Goa Plant I was about Rs. 135 crores in the year FY 2017-18.

New Delhi: Drug firm Indoco, Remedies recently announced, the Inspection Action Group (IAG) of the United Kingdom has confirmed that the GMP status for its Goa Plant I have been fully re-instated by UK regulator, The Medicines and Healthcare Products Regulatory Agency of the United Kingdom (UK-MHRA).

This is an outcome of the full GMP inspection conducted by the MHRA from May 21 till 23, 2019.

MHRA had inspected the Goa Plant I in March 2018, which resulted in an issuance of a restricted GMP certificate for medicinally critical products and a statement of non- compliance was published in the EUDRA GMDP data-base.

Subsequently, UK-MHRA conducted a ‘Focused Audit’ in October 2018 and GMP audit in May 2019. These audits were completed with no Critical Observations and Indoco has now received a full GMP status for its Goa Plant I. The revenues from Goa Plant I was about Rs. 135 crores in the year FY 2017-18.

Commenting on the same, Aditi Panandikar, Managing Director – Indoco Remedies Limited said, “Indoco continues to be quality driven and adapts & assimilates cGMP with strict adherence to the environment, patient safety and efficacy in our processes and products. With this positive development, our operations in Europe will now take off on a fast-track.”

Goa Plant I manufactures Solid Dosages, Liquid Orals and External Preparations.

Indoco Remedies, headquartered in Mumbai, has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art RnD Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.

The company has 9 domestic marketing divisions with a brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastro-intestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti-Obesity, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent-KF, Karvol Plus, Glychek, Kidodent, Carmicide, Bactogard, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis) – the USA and ASPEN-South Africa.

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