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1469 News Found

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility


Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


PHARMAP 2023 to focus on pharmaceutical challenges and strategies
News | March 22, 2023

PHARMAP 2023 to focus on pharmaceutical challenges and strategies

The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland


Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets
Drug Approval | March 21, 2023

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata
News | March 20, 2023

Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata

The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022


Jubilant receives additional CAD 23.8 million loan facility for CMO Montreal facility
News | March 17, 2023

Jubilant receives additional CAD 23.8 million loan facility for CMO Montreal facility

This loan is in addition to earlier announced CAD 25 million loan committed by the Province of Quebec


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.


USFDA completes inspection of Lupin’s Vizag facility
Drug Approval | March 11, 2023

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations