Indoco Remedies Ltd. has received the Establishment Inspection Report (approval) from US Food and Drug Administration (USFDA) for its solid dosages manufacturing facility at Goa (Plant I), thereby confirming the closure of inspection in October, 2015.
The previous USFDA inspection for this facility was held in August 2012 and this facility continues its status of being acceptable by the USFDA, since then.
“The approval by US FDA for the solid dosages facility reconfirms Indoco’s quality commitment to patient care”, said Aditi Kare -Panandikar, Managing Director of Indoco Remedies Ltd.
This plant has a capacity to manufacture 2.2 billion tablets, 32 million bottle s of liquid orals, 16 million tubes of creams and ointments and 60 million capsules of hard gelatin. This plant has capability to manufacture aqueous, non - aqueous and photosensitive products. It has HVAC system that maintains Relative Humidity to 40% +/ - 5 %.
Apart from approval from US FDA, this plant is also approved by UK - MHRA, MCC - South Africa, TGA - Australia and ANVISA - Brazil.