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Results For "regulator"

2061 News Found

Biocon Biologics embarks on a three-stage strategic journey
News | January 08, 2025

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Digitisation | January 07, 2025

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company


Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations
People | January 06, 2025

Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations

He has 29+ years’ comprehensive experience in world-class Formulations and API (for US and EU requirements) mainly related to injectables


CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia
Drug Approval | January 05, 2025

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia

Wockhardt plans to launch Miqnaf in the Indian market in coming few months


Nano-formulation of darkness hormone could be therapeutic solution for Parkinson's disease
News | January 04, 2025

Nano-formulation of darkness hormone could be therapeutic solution for Parkinson's disease

Parkinson's disease (PD) is one of the most common neurological disorders caused by the death of dopamine-secreting neurons in the brain


Anthem Biosciences files DRHP for Rs. 3,395 crore IPO
News | January 01, 2025

Anthem Biosciences files DRHP for Rs. 3,395 crore IPO

Anthem’s business comprises of CRDMO services and the manufacture and sale of Specialty Ingredients


Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist
News | January 01, 2025

Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist

Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million