USFDA inspected Goa facility, no observations issued: Indoco Remedies
The US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of Indoco Remedies for finished dosages.
New Delhi: Drug firm Indoco Remedies Friday said the US health regulator has cleared its Goa-based manufacturing facility after concluding an inspection. The US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of the company for finished dosages, Indoco Remedies said in a regulatory filing.
The health regulator had inspected the plant in November last year, it added.
Medical Dialogues had earlier reported that the firm Indoco had received two minor observations from the US health regulator for its Goa-based two plants. The US Food and Drug Administration (USFDA) had inspected Indoco's Sterile facility (Plant II) and Solid Dosages facility (Plant III) situated at L-32/33/34 Verna Industrial Estate, Goa from 14th November till 21st November 2018. The inspection concluded with Indoco receiving 2 minor observations, none of which are a repeat in nature.
The facility had received a Warning Letter from the USFDA in March 2017.
Currently, in a regulatory filing the company said, "The change in the inspection classification status from 'Official Action Initiated' (OAI) to 'Voluntary Action Initiated' for Indoco Remedies by USFDA signifies that the site has come out of the warning letter issued to the site in March 2017."
Several pending abbreviated new drug applications (ANDAs) from this facility will now be approved, it added.
Indoco Remedies is headquartered in Mumbai. In 1945, a Goan entrepreneur Mr Govind Ramnath Kare, who was in the business of wholesale and retail trade of pharmaceuticals, started a firm which he named Indo Continental Trading Company. The principal business of this firm was to import pharmaceutical formulations from Europe and distribute them in Western India.
However in 1947, after India became independent, the new Government in its bid to encourage indigenous manufacturing of medicines banned the import of several formulations. Mr G.R. Kare instead of being discouraged decided to venture into manufacturing of pharmaceuticals.
Accordingly, on 23rd August 1947, a week after India's independence, a new Company was founded with the intent to manufacture and sell pharmaceutical formulations.
Thus, Indo Continental Trading Company became Indoco Remedies Limited.