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Indoco Remedies receives US FDA approval

Indoco

Indoco Remedies Ltd, a fully integrated, research- oriented pharma company, has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (FDA) for its sterile and solid dosages facility (Goa Plant II) situated at L-32/33/34 Verna Industrial Estate, Goa. This approval confirms the closure of inspection conducted in July 2015.

The previous US FDA inspections of this facility were held in IndocoOctober 2005, February 2011 and August 2013. The company has already received the approval (EIR) for its other solid dosage facility (Goa Plant I) in the month of March 2016.

“With approval by US FDA of manufacturing facilities in Goa, the company’s commitment to quality systems stands validated. This will pave the way for speedy ANDA approvals and product launches in US,” said Aditi Kare Panandikar, managing director of Indoco Remedies Ltd.

Goa Plant II has a capacity to manufacture 30 million vials/bottles of ophthalmic solutions/ suspensions and 400 million tablets.

Apart from approval from US FDA, Indoco’s manufacturing facilities in Goa are also approved by EU- GMP, TGA-Australia, besides others.

 

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