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CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units
Policy | December 28, 2022

CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940


Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies
News | December 28, 2022

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze


Aurobindo's subsidiary Tergene Biotech receives SEC recommendation for pneumococcal 15 valent vaccine
Drug Approval | December 28, 2022

Aurobindo's subsidiary Tergene Biotech receives SEC recommendation for pneumococcal 15 valent vaccine

The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.


Alembic receives USFDA final approval for Fulvestrant Injection
Drug Approval | December 27, 2022

Alembic receives USFDA final approval for Fulvestrant Injection

Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA


Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya
Policy | December 26, 2022

Center advises states to be on alert and keep all preparedness for COVID-19 management: Dr. Mandaviya

Centre and states need to work in tandem and in a collaborative spirit as was done during the previous surges for COVID-19 prevention and management


Briefs: J. B. Chemicals & Pharmaceuticals, Dr. Reddy’s Laboratories and Piramal Enterprises
News | December 26, 2022

Briefs: J. B. Chemicals & Pharmaceuticals, Dr. Reddy’s Laboratories and Piramal Enterprises

J. B. Chemicals & Pharmaceuticals has informed that the acquisition of the Razel franchise from Glenmark Pharmaceuticals Limited has been successfully completed.


Advent International to acquire a significant stake in Suven Pharmaceuticals
News | December 26, 2022

Advent International to acquire a significant stake in Suven Pharmaceuticals

Advent will also be making an open offer to acquire additional 26% of the outstanding equity shares of the company from the public shareholders.


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Strides Pharma Global receives AUD 94 mn for sale of Australia's operations
News | December 23, 2022

Strides Pharma Global receives AUD 94 mn for sale of Australia's operations

The balance of AUD 94 Million was a deferred consideration backed by a secured interest-bearing instrument