Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
    Home » Drug Approval » Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
Drug Approval

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

  • By IPP Bureau | June 23, 2025

The United States Food and Drug Administration (USFDA) conducted an inspection at Unichem Laboratories Ltd's Roha API facility from 16th June 2025 to 20th June 2025.

The inspection closed with three observations which were more of procedural changes with none of these related to data integrity.

The company will provide the necessary response to USFDA within stipulated 15 days.

Upcoming E-conference

Other Related stories

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1
USFDA concludes inspection at Zydus' oncology injectable plant at Ahmedabad
USFDA concludes inspection of NATCO’s Pharma Division, Kothur
View More

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
View More

Appointments

Sun Pharma appoints Kirti Ganorkar as the Managing Director
Sun Pharma appoints Kirti Ganorkar as the Managing Director
Cipla appoints Prabhakaran Balakrishnan Nair as Global Chief Manufacturing Officer
Cipla appoints Prabhakaran Balakrishnan Nair as Global Chief Manufacturing Officer
Punita Lal Joins Lupin Board as Additional Director
Punita Lal Joins Lupin Board as Additional Director
View More

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
View More

Digitization

Healthcare Triangle launches Malaysian subsidiary QuantumNexis
Healthcare Triangle launches Malaysian subsidiary QuantumNexis
NVIDIA partners with Novo Nordisk and DCAI to advance drug discovery
NVIDIA partners with Novo Nordisk and DCAI to advance drug discovery
Wanbury to implement the SAP S/4 HANA private cloud platform
Wanbury to implement the SAP S/4 HANA private cloud platform
View More

Latest Stories

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Sai Life Sciences commences commercial operation of 2nd phase in Bidar

Cohance Lifesciences to sell CR Bio assets to Chromo Laboratories India for Rs. 16 Cr

Emcure to acquire remaining stake in Zuventus Healthcare

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

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
Injection filter needle market to reach $1.73 billion in 2025
Injection filter needle market to reach $1.73 billion in 2025
Can India’s pharmaceutical industry achieve self-reliance in APIs? by Chetan Shah, COO, Senores Pharmaceuticals
Can India’s pharmaceutical industry achieve self-reliance in APIs? by Chetan Shah, COO, Senores Pharmaceuticals

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
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
Evertis selects Honeywell Aclar technology to enhance pharmaceutical packaging
Evertis selects Honeywell Aclar technology to enhance pharmaceutical packaging