“The US Food and Drug Administration (USFDA) inspected the company’s sterile facility (plant II) and solid dosages facility (Plant III) situated at Goa from 14th November till 21st November 2018. The inspection concluded with the company receiving 2 minor observations, none of which are repeat in nature,” Indoco Remedies said in a press release.
This facility had received a warning letter from the USFDA in March 2017.
“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 of Indoco Remedies.
The company on Wednesday after market hours announced that the rating agency ICRA has reaffirmed rating at [ICRA]A+ for the long-term borrowing programme of the company with ‘stable’ outlook.
The trading volumes on the counter more than doubled with a combined 363,940 equity shares changed hands on the BSE and NSE. There were pending buy orders for 92,417 shares on both the exchanges at 02:08 PM.