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4698 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 .


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).


Lupin launches posaconazole delayed-release tablets
News | February 18, 2021

Lupin launches posaconazole delayed-release tablets

posaconazole delayed-release tablets 100 mg are the generic equivalent of Noxafil.


Jubilant Pharmova recovers: ICICI Securities
News | February 13, 2021

Jubilant Pharmova recovers: ICICI Securities

Jubilant announced the completion of demerger of pharma and LSI business into two separate companies


2021 will be a game-changer for pharma industry, says experts
News | February 13, 2021

2021 will be a game-changer for pharma industry, says experts

The pandemic has provided tailwinds in terms of access to rural healthcare and India’s emergence as a vaccine powerhouse


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.


Zydus completes enrolment for two Phase Ill trials of Desidustat
News | February 08, 2021

Zydus completes enrolment for two Phase Ill trials of Desidustat

The DREAM-ND Phase III trial has now enrolled 588 CKD patients not-on-dialysis.