Drug Approval

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations

Zydus announced that the USFDA has completed a Pre-Approval Inspection (PAI) and general cGMP inspection at its formulation manufacturing plant in SEZ II, Ahmedabad. The inspection, conducted from 11 to 13 August 2025 for three products, concluded with no observations.

The inspection concluded with NIL observations.

Zydus
USFDA

Upcoming E-conference

Other Related stories

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Boehringer’s lung cancer medicine gets FDA approval

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

Interviews

India rema

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 comm

Capex commitment likely to be in the range of Rs. 200-300 Cr: Dr. R. Ananthanarayanan, CEO, Sajjan India

Our focus

Our focus is on organic expansion and building our own plants...: Dr. Aman Desai, Promoter and Whole Time Director, Aether Industries

Appointments

LAXAI Life Sciences appoints Sripathy Venkatraman as CEO

LAXAI Life Sciences appoints Sripathy Venkatraman as CEO

Hexaware Technologies appoints Shantanu Baruah as President & Global Head – Healthcare, Life Sciences, and Insurance

Hexaware Technologies appoints Shantanu Baruah as President & Global Head – Healthcare, Life Sciences, and Insurance

Bio-Rad names Rajat Mehta as EVP - Global Commercial Operations

Bio-Rad names Rajat Mehta as EVP - Global Commercial Operations

Startup

Hyderabad based CSIR institutes playing pivotal role in drug discovery and genetic diagnostics: Dr. Jitendra Singh

Hyderabad based CSIR institutes playing pivotal role in drug discovery and genetic diagnostics: Dr. Jitendra Singh

Mila Beaute raises $2.16 million in pre-series A round led by Rukam Capital

Mila Beaute raises $2.16 million in pre-series A round led by Rukam Capital

Merck Life Science India signs MoU with DPIIT

Merck Life Science India signs MoU with DPIIT

Digitization

ekincare launches elva.AI to resolve 80% of employee healthcare queries

ekincare launches elva.AI to resolve 80% of employee healthcare queries

Eli Lilly inaugurates global capability centre in hyderabad to advance AI initiatives

Eli Lilly inaugurates global capability centre in hyderabad to advance AI initiatives

NIH develops AI agent to improve accuracy of gene set analysis

NIH develops AI agent to improve accuracy of gene set analysis

Latest Stories

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

Cohance Lifesciences reports 13% revenue growth in Q1 FY26

AbbVie to invest $195 million to expand API manufacturing in North Chicago

Brightmark and Lewis Salvage recycle over 1 million pounds of medical plastics

AAVantgarde Bio receives FDA fast track designation for AAVB-039 in stargardt disease

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

Opinion

Rise of Bio-based Chemicals: Hype or Game-Changer?: Dr. Sangeeta Srivastava, Executive Director, Godavari Biorefineries

Rise of Bio-based Chemicals: Hype or Game-Changer?: Dr. Sangeeta Srivastava, Executive Director, Godavari Biorefineries

Plant-based chemistry essential for home and personal care products: Vishal Sharma, Executive Director & Chief Executive Officer (Chemicals), Godrej Industries

Plant-based chemistry essential for home and personal care products: Vishal Sharma, Executive Director & Chief Executive Officer (Chemicals), Godrej Industries

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

UFlex secures Indian patent for waterborne heat seal coating for food, consumer goods packaging

UFlex secures Indian patent for waterborne heat seal coating for food, consumer goods packaging

Sanner commences manufacturing critical injection-molded components in USA

Sanner commences manufacturing critical injection-molded components in USA

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex introduces FSSAI compliant single-pellet solution for food packaging