Drug Approval

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.

The US Food and Drug Administration (USFDA) has completed a Pre- Approval Inspection (PAI) at Laurus Labs Limited manufacturing facility at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh.

The inspection was conducted from 24-28th October 2022 and the company has been issued a Form 483 with one observation. The observation is procedural in nature and the company will address the observation within stipulated timelines.

Upcoming E-conference

Biosimilars & Biologics: The Next Growth Frontiers for Indian Pharma

July 17, 2026

Register Now

Other Related stories

Teva submits FDA application for experimental Tourette syndrome treatment ecopipam

FDA fast-tracks Roche cancer drug filing after landmark trial shows 50% recurrence reduction

Aurobindo Pharma USA secures FTC clearance for $250 million Lannett acquisition

Interviews

India is b

India is becoming centre of innovation and global execution: Sanjay Vyas, President and MD, Parexel India

Cancer tre

Cancer treatment must move beyond one-size-fits-all decisions: Dr. Manjiri Bakre, CEO and Founder, OncoStem Diagnostics

We plan to

We plan to invest nearly $100 million in new infrastructure, biologics and AI-driven drug discovery,: Akhil Ravi, CEO, Aurigene

Appointments

Pfizer CFO Dave Denton to exit

Pfizer CFO Dave Denton to exit

Saurabh Gambhir elevated to Chief Strategy Officer (Global) at Cipla

Saurabh Gambhir elevated to Chief Strategy Officer (Global) at Cipla

Dr. Dhananjay Kumar Tiwary gets additional charge as Managing Director of BIRAC

Dr. Dhananjay Kumar Tiwary gets additional charge as Managing Director of BIRAC

Startup

Lumos Health opens applications for second cohort of HealthTech and MedTech startups

Lumos Health opens applications for second cohort of HealthTech and MedTech startups

Hoola Health raises $5 million to expand child-centric paediatric care

Hoola Health raises $5 million to expand child-centric paediatric care

HealthFab raises Rs 20 crore in Series A funding from Atomic Capital

HealthFab raises Rs 20 crore in Series A funding from Atomic Capital

Digitization

CENT expands to Delhi-NCR with new clinical prevention centre in Gurugram

CENT expands to Delhi-NCR with new clinical prevention centre in Gurugram

proRITHM named among top 4 AI-based healthcare technologies

proRITHM named among top 4 AI-based healthcare technologies

Life sciences firms move from AI pilots to scaled adoption, finds KPMG Global Tech Report 2026

Life sciences firms move from AI pilots to scaled adoption, finds KPMG Global Tech Report 2026

Upcoming E-conference

July 17, 2026 Biosimilars & Biologics: The Next Growth Frontiers for Indian Pharma

Latest Stories

Shilpa Biologicals' PartnerPower promises real-time transparency in biologics development

KIMS Hospitals launches RENOVA Oncology Institute in Bengaluru

Teva submits FDA application for experimental Tourette syndrome treatment ecopipam

FDA advisory panel backs Moderna flu vaccine candidate for older adults

FDA clears 131 drugs as global pharma approval momentum rebounds in 2025

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

NCAHP Act has built backbone of India’s healthcare workforce: Nalin Saluja, Co-Founder & CTO, Virohan

NCAHP Act has built backbone of India’s healthcare workforce: Nalin Saluja, Co-Founder & CTO, Virohan

Insect biotech as India's next deeptech opportunity: Ankit Alok Bagaria, Co-founder and CEO, Loopworm

Insect biotech as India's next deeptech opportunity: Ankit Alok Bagaria, Co-founder and CEO, Loopworm

Interviews

India is becoming centre of innovation and global execution: Sanjay Vyas, President and MD, Parexel India

India is becoming centre of innovation and global execution: Sanjay Vyas, President and MD, Parexel India

Sanjay Vyas President and Managing Director, Parexel India And Global SBU Head- Safety services & Logistics, Parexel International

Cancer treatment must move beyond one-size-fits-all decisions: Dr. Manjiri Bakre, CEO and Founder, OncoStem Diagnostics

Cancer treatment must move beyond one-size-fits-all decisions: Dr. Manjiri Bakre, CEO and Founder, OncoStem Diagnostics

Dr. Manjiri Bakre CEO and Founder, OncoStem Diagnostics

We plan to invest nearly $100 million in new infrastructure, biologics and AI-driven drug discovery,: Akhil Ravi, CEO, Aurigene

We plan to invest nearly $100 million in new infrastructure, biologics and AI-driven drug discovery,: Akhil Ravi, CEO, Aurigene

Akhil Ravi Chief Executive Officer, Aurigene Pharmaceutical Services Limited

Packaging

Clariant boosts high-speed packaging efficiency with expanded continuous strip desiccant reels

Clariant boosts high-speed packaging efficiency with expanded continuous strip desiccant reels

Coveris invests €1.8m in Poland to boost speed, capacity & packaging innovation

Coveris invests €1.8m in Poland to boost speed, capacity & packaging innovation

Northamptonshire NHS Trust ditches disposable cups in bold sustainability move

Northamptonshire NHS Trust ditches disposable cups in bold sustainability move