Biperiden Hydrochloride

Indian drugmaker Maithili Life Sciences has received a non-compliant report from the Brussels-based Federal Agency for Medicines and Health Products for 24 issues related to Maithili’s active pharmaceutical ingredient manufacturing. An inspection of the manufacturer’s factory in Andhra Pradesh, India, ending in November 2024 revealed the problems, according to a report published by the European Medicines Agency and the Belgian regulator. Due to the discrepancies, the FAMHP recommended that Maithili be removed as a manufacturer of active substances and intermediates. The agency also recommended blocking Maithili from supplying products made at the Andhra Pradesh facility, as long as there are alternate suppliers and it wouldn’t cause drug shortages. In particular, the report states the company should be suspended from making its biperiden hydrochloride product, which is a muscarinic receptor antagonist used to treat the muscle spasms and stiffness caused by Parkinson’s disease. The regulator also recommended an assessment of Maithili’s products to decide if the drugmaker should recall batches of its APIs. In addition, all imported products from the Andhra Pradesh factory should be retested, the report states. The 24 deficiencies outlined in the report include issues regarding the cleanliness and maintenance of manufacturing equipment, which could lead to contamination and cross-contamination of APIs. In addition to manufacturing commercial APIs and other raw materials, Maithili Life Sciences also offers research and development capabilities for intermediates and other chemicals, according to its website. It ships its products globally and domestically.