UK-MHRA reinstates full GMP status for Indoco’s Goa Plant I
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
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.
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