JB Chemical gets US FDA approval for manufacturing facility at Gujarat

▴ JB Chemichal
The said inspection was carried out from 24th June to 28th June 2019. At the end of the inspection, "No Objectionable Observation" was found and no Form 483 was issued.This new facility known as (T20) has already been approved by the other regulatory authorities like EU, TGA-Australia, Saphra-South

According to the statement issued by JB Chemical, Company is in receipt of the Establishment Inspection Report (EIR) from the US FDA for the Company's newly set up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat. The US FDA issues an EIR to the Company when an inspection is satisfactorily "closed".

The said inspection was carried out from 24th June to 28th June 2019. At the end of the inspection, "No Objectionable Observation" was found and no Form 483 was issued.This new facility known as (T20) has already been approved by the other regulatory authorities like EU, TGA-Australia, Saphra-South Africa. This is another facility in addition to the one already approved by US FDA.The new facility will augment the Company's manufacturing capacity for regulated markets like USA, EU, Australia and South Africa.

Established in 1976, J.B.Chemicals & Pharmaceuticals Ltd. (JBCPL) is one of India’s fastest-growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally. Today, JBCPL exports to over 30 countries across the world and earns more than half its revenue from its international business.

JBCPL is widely committed to manufacturing a range of innovative speciality products that include various pharmaceutical dosage forms like tablets, injectable (vials, ampoules, form fill seal), creams & ointments, lozenges, herbal liquids and capsules.

JBCPL has its headquarters in India’s financial capital, Mumbai. With a domestic sales force of 1,000 people, 17 internationally approved state of the art manufacturing units, a Research and Development Centre, and subsidiaries abroad, the organisation is continually enhancing value for its shareholders.

In India and International markets, JBCPL is also known as Unique Pharmaceutical Laboratories and is a division of JBCPL.

Tags : #USFDA #Jbchem #Manufacturingfacility

Related Stories

Loading Please wait...

-Advertisements-



Trending Now

Why Local Medical Device Manufacturing Matters for Indian HealthcareSeptember 16, 2026
Next-Generation Surgical Robots Entering the Indian Market: What It Means for Patients and ProvidersSeptember 16, 2026
Hospital Data Breaches in India: What Every Patient Needs to Know Right NowSeptember 15, 2026
Cybersecurity of ICUs: Protecting Connected Critical-Care Systems in Indian HospitalsSeptember 15, 2026
A Practical Guide to Fibre: How Indian Adults Can Add More Without Digestive DiscomfortSeptember 12, 2026
Understanding Heart Palpitations: Common Triggers, Helpful Records, and Warning SignsSeptember 12, 2026
The Fourth Trimester: Why Healthcare Often Stops Too Early After DeliverySeptember 12, 2026
Postpartum Mental Health: The Healthcare Gap Nobody Talks About EnoughSeptember 12, 2026
Fortis Escorts Faridabad Launches Region’s First Dedicated ‘Fever Clinic’ for Early Diagnosis and Timely TreatmentSeptember 11, 2026
Aksigen IVF Expands Science-led Fertility Care with New Integrated Centre in PanvelSeptember 11, 2026
MGM Cancer Institute Marks World Rose Day with Milestone of 100 Bone Marrow Transplants and Launch of SwasthiSeptember 11, 2026
Government of Rajasthan & Girl Effect India launch ‘Teeka Talk’ to increase HPV Vaccination Awareness Across the StateSeptember 11, 2026
Healthy Snacks for Children: Smart Indian Alternatives to Highly Processed FoodsSeptember 11, 2026
Understanding Constipation: Fibre, Fluids, Movement, and When Symptoms Need AttentionSeptember 11, 2026
Medical Device Cybersecurity: When a Connected Device Becomes a Security RiskSeptember 11, 2026
Zero-Trust Security for Hospitals: Why Traditional Network Security Is No Longer EnoughSeptember 11, 2026
Understanding Vertigo: Why the Room Feels Like It Is Spinning and What to Do NextSeptember 10, 2026
Healthy Eating on a Budget: Nutritious Indian Meals for FamiliesSeptember 10, 2026
AI in Ultrasound: How Intelligent Imaging Could Transform Diagnostic Access in IndiaSeptember 10, 2026
How AI Is Changing Pathology Laboratories in IndiaSeptember 10, 2026