IPP Bureau

Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun
Sun Pharma and Philogen enter into a exclusive commercialization and supply agreement for Fibromun

By IPP Bureau - October 02, 2024

Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun

Zydus receives EIR for the transdermal manufacturing facility
Zydus receives EIR for the transdermal manufacturing facility

By IPP Bureau - October 02, 2024

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

By IPP Bureau - October 02, 2024

The product is expected to be launched in Q3FY25

SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
SMS Pharma receives EDQM certification to supply Ibuprofen in Europe

By IPP Bureau - October 02, 2024

The inspection conducted by EDQM at its Visakhapatnam facility

Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Zydus receives tentative approval from USFDA for Enzalutamide Tablets

By IPP Bureau - October 02, 2024

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

By IPP Bureau - October 02, 2024

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022

Apitoria Pharma gets Form 483 with 10 observations from USFDA
Apitoria Pharma gets Form 483 with 10 observations from USFDA

By IPP Bureau - October 01, 2024

The observations are of procedural in nature and will be responded to within the stipulated time

Venus Remedies secures marketing authorisations for key oncology drugs from Morocco
Venus Remedies secures marketing authorisations for key oncology drugs from Morocco

By IPP Bureau - October 01, 2024

The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia

Morepen Laboratories appoints Amrit Ravi as Vice President
Morepen Laboratories appoints Amrit Ravi as Vice President

By IPP Bureau - October 01, 2024

He holds a Master’s in Management from the National University of Singapore

Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers
Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers

By IPP Bureau - October 01, 2024

The special financing terms offered by United Imaging and structured by Medikabazaar to Krsnaa Diagnostics underscore the strategic importance of this alliance

Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky
Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky

By IPP Bureau - October 01, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

By IPP Bureau - September 30, 2024

The inspection concluded with the issuance of a form 483 with five observations

USFDA inspection update on Jubilant HollisterStier’s Montreal facility
USFDA inspection update on Jubilant HollisterStier’s Montreal facility

By IPP Bureau - September 30, 2024

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

Dr. Reddy's invests US$ 620 million in Switzerland subsidiary
Dr. Reddy's invests US$ 620 million in Switzerland subsidiary

By IPP Bureau - September 30, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

By IPP Bureau - September 29, 2024

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations

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