UK REGULATORS reinstate full GMP status for INDOCO REMEDIES’ Goa plant

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company Indoco Remedies Ltd said of full GMP (Good Manufacturing Practice) status being reinstated at Indoco Remedies Ltd’s Goa plant.

In a press-communication as addressed by the company to the Indian Bourses titled – “UK-MHRA reinstates full GMP status for Indoco’s Goa Plant I” further read that, Indoco Remedies announced that the Inspection Action Group (IAG) of the United Kingdom has confirmed that the GMP status for its Goa Plant I has 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- 23,2019.

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

Subsequently UK-MHRAconducted 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 were about Rs.135 crores in the year FY2017-18.

“Indoco continues to be quality driven and adapts & assimilates cGMP with strict adherence to nvironment, 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.”, said Ms. Aditi Panandikar, Managing Director – Indoco Remedies limited.

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