IPP Bureau

USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi
USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi

By IPP Bureau - September 02, 2022

Zydus receives final approval from USFDA for two tablets
Zydus receives final approval from USFDA for two tablets

By IPP Bureau - September 01, 2022

The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04

US FDA issues 17 observations for Biocon Biologics sites
US FDA issues 17 observations for Biocon Biologics sites

By IPP Bureau - September 01, 2022

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools

Stelis Biopharma’s flagship facility receives EIR from USFDA
Stelis Biopharma’s flagship facility receives EIR from USFDA

By IPP Bureau - September 01, 2022

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise

Bayer showcases cancer study data at ESMO Congress 2022
Bayer showcases cancer study data at ESMO Congress 2022

By IPP Bureau - September 01, 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors

A 10-year commission with dedicated mission is required to tackle the upsurge of diabetes in India: says Expert
A 10-year commission with dedicated mission is required to tackle the upsurge of diabetes in India: says Expert

By IPP Bureau - September 01, 2022

India is at the forefront of research in cardiology worldwide but making indigenous products is what we are lacking & it needs to be improved

Bayer initiates Phase III study program to investigate oral FXIa inhibitor asundexian
Bayer initiates Phase III study program to investigate oral FXIa inhibitor asundexian

By IPP Bureau - September 01, 2022

The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke

Hydration of proteins could act as a potential marker for an early detection of neuro-degenerative diseases
Hydration of proteins could act as a potential marker for an early detection of neuro-degenerative diseases

By IPP Bureau - September 01, 2022

This dense phase often resembles liquid droplets exhibiting higher protein density and weaker molecular motion than the surrounding medium.

Medix Biochemica appoints former Roche executive to its Board of Directors
Medix Biochemica appoints former Roche executive to its Board of Directors

By IPP Bureau - September 01, 2022

Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies.

Biological E. announces CDSCO recommendation of its infant’s vaccine
Biological E. announces CDSCO recommendation of its infant’s vaccine

By IPP Bureau - September 01, 2022

Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)

Merck India inaugurates R&D Excellence Centre in Bangalore
Merck India inaugurates R&D Excellence Centre in Bangalore

By IPP Bureau - September 01, 2022

The Centre aims at promoting innovation among the scientific community to improve healthcare solutions around the globe

Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA
Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA

By IPP Bureau - September 01, 2022

COVID-19 Vaccine (DS-5670) in Unvaccinated Individuals in Japan

Cipla (EU) to acquire an additional 13.10% stake in Cipla (Jiangsu) Pharmaceutical
Cipla (EU) to acquire an additional 13.10% stake in Cipla (Jiangsu) Pharmaceutical

By IPP Bureau - August 31, 2022

Post-acquisition, Cipla EU's stake in the subsidiary will increase to 93.10%.

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets
Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

By IPP Bureau - August 31, 2022

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets
Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

By IPP Bureau - August 31, 2022

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