This story is from May 27, 2016
Indoco Remedies Limited
has received the go-ahead from the US food and drug administration (USFDA
) to manufacture and supply sterile and solid dosages for the US market. “With approval by USFDA of manufacturing facilities in Goa, the company’s commitment to quality systems stands validated. This will pave way for speedy abbreviated new drug application (ANDA) approvals and product launches in US”, managing director of Indoco RemediesAditi Kare Panandikar
, said. Indoco Remedies said it had received the establishment inspection report (EIR) from USFDA for its sterile and solid dosages facility situated at Verna industrial estate, Goa. “This approval confirms the closure of inspection conducted in July 2015,” the company added. The plant approved by USFDA can manufacture 30 million vials or bottles of ophthalmic solutions, suspensions and 400 million tablets. The previous USFDA inspections of this facility were held in October 2005, February 2011 and August 2013. Indoco Remedies had already received the approval (EIR) for its other solid dosage plant in the month of March 2016. Apart from the USFDA approval, Indoco’s manufacturing facilities in the state are also approved by EU-GMP, TGA-Australia, besides others. The company has eight manufacturing facilities, supported by a state-of-the-art research and development centre. The facilities have been approved by US FDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets.
Start a Conversation
Post comment