Indoco Remedies had announced earlier about MHRA inspection at Goa Plant I from March 14, 2018 to March 16, 2018, wherein, 3 critical and 4 major observations were identified. The company has now 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 are 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 our customers.
This will have a temporary impact on our business to Europe, which we will minimize by transferring products from the affected facility (Goa I) to our other manufacturing facilities (Goa III and Baddi I)holding valid EU GMP certification.
Shares of the company gained Rs 1.75, or 0.85%, to trade at Rs 207.50. The total volume of shares traded was 467 at the BSE (9.48 a.m., Thursday).