This positive development will now pave the way for approval of our pending ANDAs with consequent boost to revenues from the US market
The US Food and Drug Administration (US FDA) inspected Indoco’s Sterile facility (Plant II) and Solid Dosages facility (Plant III) situated at L-32/33/34 Verna Industrial Estate, Goa dated November 14 -21 2018. The inspection concluded with Indoco receiving 2 minor observations, none of which are a repeat in nature. This facility had received a Warning Letter from the US FDA 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 US FDA 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 Aditi Kare Panandikar, Managing Director, Indoco Remedies.
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