Jubilant Life Sciences gets FDA nod for anti inflammatory drug
Jubilant Life Sciences is reported to have received an approval from the US health regulator for its drug application of Indomethacin capsule, to be used to treat pain.The anti inflammatory capsule will be manufactured, and distributed in the strength of 75 mg, and is said to be a non steroidal anti inflammatory capsule to be made available in the US market.In a BSE filing, Jubilant Life...
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Jubilant Life Sciences is reported to have received an approval from the US health regulator for its drug application of Indomethacin capsule, to be used to treat pain.
The anti inflammatory capsule will be manufactured, and distributed in the strength of 75 mg, and is said to be a non steroidal anti inflammatory capsule to be made available in the US market.
In a BSE filing, Jubilant Life Sciences said it "received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Indomethacin ER Capsule 75mg, which is a non-steriodal anti-inflammatory drug used for treatment of pain".
Jubilant Life Sciences said as on June 30, 2015, it had a total of 815 filings for formulations of which 389 have been approved in various regions globally.
"This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe," it added.
The anti inflammatory capsule will be manufactured, and distributed in the strength of 75 mg, and is said to be a non steroidal anti inflammatory capsule to be made available in the US market.
In a BSE filing, Jubilant Life Sciences said it "received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (USFDA) for Indomethacin ER Capsule 75mg, which is a non-steriodal anti-inflammatory drug used for treatment of pain".
Jubilant Life Sciences said as on June 30, 2015, it had a total of 815 filings for formulations of which 389 have been approved in various regions globally.
"This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe," it added.
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