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Home > News > Indoco's Goa Plant II & III clears USFDA inspection

Indoco's Goa Plant II & III clears USFDA inspection

Chemical Weekly 2018-12-10

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The 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 November 14-21, 2018. The inspection concluded with Indoco receiving two minor observations, none of which are repeat. 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.

“This positive development will now pave the way for approval of our pending ANDAs with consequent boost to revenues from the US market. Indoco is committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture,” said Ms. Aditi Kare Panandikar, Managing Director of Indoco Remedies Ltd.

Disclaimer: ECHEMI reserves the right of final explanation and revision for all the information.

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