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Results For "Complete-Response-Letter"

13 News Found

USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant

Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.

Latest Stories

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

Aarti Pharmalabs inaugurates phase 1 of greenfield manufacturing facility

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

White Papers

Chasing Consistency: Centralizing operations data is the key to optimizing chemicals plants

Implementing a digital transformation in chemical operations to maximize profitability

The complexity of compliance

The Sprint to the Summit: Unlocking Lab Efficiency through Digital Transformation

The guiding role of fluidized and spouted bed technologies in particle building processes

Interviews
India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant
India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant
Capex commitment likely to be in the range of Rs. 200-300 Cr: Dr. R. Ananthanarayanan, CEO, Sajjan India
Capex commitment likely to be in the range of Rs. 200-300 Cr: Dr. R. Ananthanarayanan, CEO, Sajjan India
Dr. R. Ananthanarayanan CEO, Sajjan India
Our focus is on organic expansion and building our own plants...: Dr. Aman Desai, Promoter and Whole Time Director, Aether Industries
Our focus is on organic expansion and building our own plants...: Dr. Aman Desai, Promoter and Whole Time Director, Aether Industries
Dr. Aman Desai Promoter and Whole Time Director, Aether Industries

Packaging