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 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 were about Rs. 135 crores in the year FY 2017-18.
“Indoco continues to be quality driven and adapts & assimilates cGMP with strict adherence to 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.”, said Ms. Aditi Panandikar, Managing Director – Indoco Remedies Limited.