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7944 News Found

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.


Unichem Laboratories receives ANDA approval for Apremilast Tablets
News | February 20, 2021

Unichem Laboratories receives ANDA approval for Apremilast Tablets

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .


Zydus Cadila receives final approval from USFDA for Droxidopa capsules
News | February 20, 2021

Zydus Cadila receives final approval from USFDA for Droxidopa capsules

It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.


Lupin receives approval for Droxidopa capsules
News | February 20, 2021

Lupin receives approval for Droxidopa capsules

Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness


Granules India announces approval of Potassium Chloride ER Capsules
News | February 18, 2021

Granules India announces approval of Potassium Chloride ER Capsules

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).


Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member


Approval accorded under PLI Scheme for domestic manufacturing of medical devices
News | February 12, 2021

Approval accorded under PLI Scheme for domestic manufacturing of medical devices

The medical device Sector in India suffers from a considerable cost of manufacturing disability.


Glenmark receives ANDA approval for Clindamycin Phosphate Gel
News | February 12, 2021

Glenmark receives ANDA approval for Clindamycin Phosphate Gel

According to IQVIA sales data for the 12 month period ending December 2020, the Cleocin T Gel, 1% market achieved annual sales of approximately $73.8 million.


Lupin receives approval for tavaborole topical solution
News | February 10, 2021

Lupin receives approval for tavaborole topical solution

Tavaborole Topical Solution, 5%, is an oxaborole antifungal.


Aurobindo Pharma gets approval for 3 products under PLI Scheme: ICICI Securities
News | January 26, 2021

Aurobindo Pharma gets approval for 3 products under PLI Scheme: ICICI Securities

Post approval under the PLI scheme, Aurobindo will become a very large player in anti-biotic space.