Indoco Remedies’ Goa Plant I has received a statement of non-compliance and restricted GMP certificate to permit continued manufacture and testing of products considered to be medically critical or to ensure continuity of supply, as determined by the national competent authority.
The MHRA statement also says that, there is no evidence of product having been impacted and therefore the inspectorate does not recommend that the products are recalled.
The company is in communication with the European Health authorities and hopeful of getting early resolution. In the interim, medically critical products will be allowed to be supplied from the affected facility, the list of which is being finalised by MHRA and other National Competent authorities in coordination with the company’s customers.
This will have a temporary impact on the company’s business to Europe, which the company will minimize by transferring products from the affected facility (Goa I) to their other manufacturing facilities (Goa III and Baddi I) holding valid EU GMP certification.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
