Express Pharma

Indoco Remedies receives USFDA nod for solid dosages plant I in Goa

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The plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of creams and ointments and 60 million capsules of hard gelatin

Indoco Remedies has received the Establishment Inspection Report (approval) from US Food and Drug Administration (US FDA) for its solid dosages manufacturing facility at Goa (Plant I), thereby confirming the closure of inspection in October, 2015.

The previous US FDA inspection for this facility was held in August 2012 and this facility continues its status of being acceptable by the US FDA, since then.

“The approval by US FDA for the solid dosages facility re-confirms Indoco’s quality commitment to patient care,” said Aditi Kare-Panandikar, Managing Director, Indoco Remedies.

This plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of creams and ointments and 60 million capsules of hard gelatin. The plant has capability to manufacture aqueous, non-aqueous and photosensitive products. It has HVAC system that maintains relative humidity to 40 per cent +/- five per cent.

Apart from approval from US FDA, this plant is also approved by UK-MHRA, MCC-South Africa, TGA-Australia and ANVISA-Brazil.

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