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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


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)


Zydus granted Orphan Drug Designation by USFDA for ZYIL1
Drug Approval | March 22, 2023

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates


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)


Serum Institute of India likely front-runner to win supply of HPV vaccines for UIP, says GlobalData
News | March 21, 2023

Serum Institute of India likely front-runner to win supply of HPV vaccines for UIP, says GlobalData

The Indian government will float a global tender in April 2023 to procure HPV vaccines.


Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing
Clinical Trials | March 21, 2023

Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing

All children (100%) in the presymptomatic intravenous cohort of LT-002 maintained or achieved all assessed motor milestones, including independent walking