Indoco Remedies gets two minor observations from USFDA for Goa plants
Mumbai: Drug firm Indoco Remedies on Thursday said it has received two minor observations from the US health regulator for its Goa-based two plants. The US Food and Drug Administration (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 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.
The Company said it 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, it added.
"This positive development will now pave the way for approval of our pending ANDAs with a 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 Ltd.
"The inspection concluded with the company receiving two minor observations, none of which are a repeat in nature," Indoco Remedies said in a regulatory filing.
Headquartered in Mumbai, Indoco Remedies is a fully integrated, research-oriented pharma Company and has nine manufacturing facilities. It has a presence across 55 countries. Indoco, a USD 161 million Company, employs over 5500 people including more than 300 skilled scientists.
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.
Also Read: Indoco Remedies Goa unit receives approval from UK health regulator
The facility had received a Warning Letter from the USFDA in March 2017.
The Company said it 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, it added.
"This positive development will now pave the way for approval of our pending ANDAs with a 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 Ltd.
"The inspection concluded with the company receiving two minor observations, none of which are a repeat in nature," Indoco Remedies said in a regulatory filing.
Headquartered in Mumbai, Indoco Remedies is a fully integrated, research-oriented pharma Company and has nine manufacturing facilities. It has a presence across 55 countries. Indoco, a USD 161 million Company, employs over 5500 people including more than 300 skilled scientists.
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.
Also Read: Indoco Remedies Goa unit receives approval from UK health regulator
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