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 21 -23 May 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.
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