IPP Bureau

Granules India receives ANDA approval for Levetiracetam Tablets
Granules India receives ANDA approval for Levetiracetam Tablets

By IPP Bureau - June 15, 2023

Granules now has a total of 58 ANDA approvals from US FDA

Baghel inaugurates the World Blood Donor Day at RML Hospital
Baghel inaugurates the World Blood Donor Day at RML Hospital

By IPP Bureau - June 15, 2023

The slogan for this year's World Blood Donor Day campaign is 'Give blood, give plasma, share life, share often'

Euroapi plans initiatives to support production of APIs in France and Europe
Euroapi plans initiatives to support production of APIs in France and Europe

By IPP Bureau - June 15, 2023

Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

By IPP Bureau - June 14, 2023

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Granules India received ANDA approval for Metoprolol Succinate ER Tablets
Granules India received ANDA approval for Metoprolol Succinate ER Tablets

By IPP Bureau - June 14, 2023

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

Ampath expands its footprint in Andhra Pradesh
Ampath expands its footprint in Andhra Pradesh

By IPP Bureau - June 14, 2023

Launched Pathology Laboratory in Vijayawada offering a wide range of best-in-class diagnostic services with over 2500+ tests

Samsung Biologics and Pfizer collaborate for long-term manufacturing of biosimilars portfolio
Samsung Biologics and Pfizer collaborate for long-term manufacturing of biosimilars portfolio

By IPP Bureau - June 14, 2023

Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio

Merck gets favourable verdict in patent infringement lawsuit related to Bridion
Merck gets favourable verdict in patent infringement lawsuit related to Bridion

By IPP Bureau - June 14, 2023

Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.

Pfizer and GSK to battle for share of new RSV vaccine market, says GlobalData
Pfizer and GSK to battle for share of new RSV vaccine market, says GlobalData

By IPP Bureau - June 13, 2023

Pfizer is likely to show GSK significant competition

InnoCan submits new patent applications for advanced pain relief technology
InnoCan submits new patent applications for advanced pain relief technology

By IPP Bureau - June 13, 2023

The application is in line with Innocan's strategy to expand the scope of its combined magnesium and cannabis topical solution

Croma-Pharma enrolls first patient in hyaluronic acid dermal filler clinical trial in China
Croma-Pharma enrolls first patient in hyaluronic acid dermal filler clinical trial in China

By IPP Bureau - June 13, 2023

The randomised, multi-centre, evaluator blinded, parallel group, active controlled Phase 3 trial is being led by Lanhzou Biotechnique Development

Biostar announces first patient enrolled for Phase 1 study of Utidelone Capsule
Biostar announces first patient enrolled for Phase 1 study of Utidelone Capsule

By IPP Bureau - June 13, 2023

UTD2 is the world's first oral epothilone microtubule inhibitor

Astellas submits new drug application for Zolbetuximab in Japan
Astellas submits new drug application for Zolbetuximab in Japan

By IPP Bureau - June 13, 2023

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers

Solvay to build a multipurpose microbiology lab in Europe
Solvay to build a multipurpose microbiology lab in Europe

By IPP Bureau - June 13, 2023

The new lab will enable the Group to accelerate its efforts in this area, building new competencies and capabilities, as well as strengthening Solvay’s ability to develop breakthroughs in biodegradable-by-design solutions.

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

By IPP Bureau - June 12, 2023

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

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