Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 56

Results For "regulatory"

1140 News Found

BASF Pharma Solutions excipient accepted into FDA Pilot Program
Drug Approval | December 06, 2022

BASF Pharma Solutions excipient accepted into FDA Pilot Program

Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients


Lonza’s API manufacturing facility expansion in Nansha starts commercial operation
News | December 06, 2022

Lonza’s API manufacturing facility expansion in Nansha starts commercial operation

Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production


Jemperli RUBY phase III trial met its primary endpoint
Diagnostic Center | December 05, 2022

Jemperli RUBY phase III trial met its primary endpoint

Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Briefs: Piramal Enterprises and Shilpa Medicare
News | December 02, 2022

Briefs: Piramal Enterprises and Shilpa Medicare

Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval


Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
News | December 01, 2022

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business
News | November 30, 2022

Biocon Biologics completes acquisition of Viatris' Global Biosimilars Business

To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan


Gland Pharma to buy French pharma company Cenexi
News | November 30, 2022

Gland Pharma to buy French pharma company Cenexi

Gland Pharma enters into a Put Option Agreement to acquire 100% of Cenexi Group


AstraZeneca’s Dapagliflozin receives CDSCO approval
Drug Approval | November 30, 2022

AstraZeneca’s Dapagliflozin receives CDSCO approval

Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD