The US Food and Drug Administration (USFDA) inspected Indoco’s Sterile facility (Plant II) and Solid Dosages facility (Plant III) situated at L-32/33/34 Verna Industrial Estate, Goa from 14th November till 21st November, 2018. The inspection concluded with Indoco receiving 2 minor observations, none of which are repeat in nature. This facility had received a Warning Letter from the USFDA in March 2017.
The Company is in the process of responding to the observations within the stipulated time of 15 days. The EIR will be issued by the USFDA subsequently.
About Indoco Remedies Limited:
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. Indoco, a USD 161 million Company, employs over 5500 people including more than 300 skilled scientists.
The Company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 70 million prescriptions annually from around 3,10,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastro-intestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti-Obesity, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent-KF, Karvol Plus, Glychek, Tuspel Plus, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis) – USA and ASPEN-South Africa.