SeQuent unit gets establishment inspection report from USFDA
NEW DELHI: Drug firm SeQuent Scientific today said it has received a report from the US health regulator, indicating closure of inspection of its plant.The company's active pharmaceutical ingredient (API) drug manufacturing facility in Karnataka, which was inspected by the US Food and Drug Administration (USFDA) in June 2015 as part of good manufacturing practice compliance audit..."......
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NEW DELHI: Drug firm SeQuent Scientific today said it has received a report from the US health regulator, indicating closure of inspection of its plant.
The company's active pharmaceutical ingredient (API) drug manufacturing facility in Karnataka, which was inspected by the US Food and Drug Administration (USFDA) in June 2015 as part of good manufacturing practice compliance audit...
"... has received establishment inspection report, thereby confirming closure of inspection in June 2015, SeQuent Scientific said in a BSE filing.
The previous USFDA inspection for the facility was in 2012 and it continues its status of being acceptable by the agency, it added.
The Mangalore facility is engaged in the development and manufacture of APIs and API intermediaries.
In addition to the FDA, the site is approved by TGA (Australia) and WHO (Geneva).
The facility specialises in niche and difficult to manufacture APIs and has five of its APIs prequalified by WHO prequalification of medicines programme, the company said.
SeQuent Scientific shares were trading 1 per cent up at Rs 887 apiece during afternoon session on BSE.
The company's active pharmaceutical ingredient (API) drug manufacturing facility in Karnataka, which was inspected by the US Food and Drug Administration (USFDA) in June 2015 as part of good manufacturing practice compliance audit...
"... has received establishment inspection report, thereby confirming closure of inspection in June 2015, SeQuent Scientific said in a BSE filing.
The previous USFDA inspection for the facility was in 2012 and it continues its status of being acceptable by the agency, it added.
The Mangalore facility is engaged in the development and manufacture of APIs and API intermediaries.
In addition to the FDA, the site is approved by TGA (Australia) and WHO (Geneva).
The facility specialises in niche and difficult to manufacture APIs and has five of its APIs prequalified by WHO prequalification of medicines programme, the company said.
SeQuent Scientific shares were trading 1 per cent up at Rs 887 apiece during afternoon session on BSE.
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