The Medicines and Healthcare Products Regulatory Agency of the United Kingdom (UK-MHRA) has reinstated full GMP status for Indoco Remedies’ Goa Plant I. 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-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.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
