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1549 News Found

Roquette to acquire Qualicaps from Mitsubishi Chemical Group
News | August 03, 2023

Roquette to acquire Qualicaps from Mitsubishi Chemical Group

Qualicaps is the third largest producer of hard capsules for oral dosage solutions


Lupin receives approval from US FDA for Turqoz
Drug Approval | August 02, 2023

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)


Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Drug Approval | August 01, 2023

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy


Eugia Pharma receives USFDA approval for Plerixafor Injection
Drug Approval | July 26, 2023

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023


Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr
News | July 26, 2023

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr

Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24


NATCO files generic Erdafitinib Tablets in USA
Drug Approval | July 26, 2023

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Drug Approval | July 24, 2023

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines


Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
Drug Approval | July 24, 2023

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India