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Results For "ANDA"

2095 News Found

WuXi STA launches parenteral formulation manufacturing line at Wuxi
News | December 01, 2022

WuXi STA launches parenteral formulation manufacturing line at Wuxi

This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units


JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
Drug Approval | December 01, 2022

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology


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.


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


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


LPU organizes conference on welfare of global community
News | November 27, 2022

LPU organizes conference on welfare of global community

Joint Drugs Controller (India) Dr PBN Prasad shared his views about working during harsh COVID-19 pandemic days


AstraZeneca receives import and market permission from CDSCO for Dapagliflozin
Drug Approval | November 26, 2022

AstraZeneca receives import and market permission from CDSCO for Dapagliflozin

The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


USFDA issues warning letter to Glenmark's Goa manufacturing facility
News | November 24, 2022

USFDA issues warning letter to Glenmark's Goa manufacturing facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed