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

The Role of Genetic Profiles in Alzheimer’s Therapy: APOE4 and Treatment ResponsesMay 08, 2024
Assessing Covishield Safety: Indian Research Offers Reassurance Amidst Rare Side Effect DiscussionsMay 08, 2024
Quadria Capital Invests $102 Million in NephroPlus to Boost Dialysis Services Across AsiaMay 08, 2024
Reducing Stigma, One Story at a Time: Media's Role in Mental HealthMay 07, 2024
When Your Body Makes Beer: Exploring the Curious Case of Auto-Brewery SyndromeMay 07, 2024
Hair Today, Gone Tomorrow: Why Guys Go Bald Before Marriage May 07, 2024
Menopausal Transitions and Mental Health: UCL Study Highlights Increased Depression RiskMay 07, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Harnessing AI for Early Alzheimer's Disease Diagnosis: IIT Indore's BreakthroughMay 06, 2024
Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny: Understanding the ObservationsMay 06, 2024
Exploring the Role of Mediator Protein Complex in Cell Division: Implications for Disease ManagementMay 06, 2024
Akshay Tritiya Parna Mahotsav is to be held in the cityMay 04, 2024
Bharti Singh's Battle with Gallstones: Symptoms, Precautions, and Natural RemediesMay 04, 2024
Empowering Women's Health: New Mammogram GuidelinesMay 04, 2024
Rising Temperatures, Rising Risks: Addressing the Challenges of Heat StressMay 04, 2024
Gynoveda, India's First Ayurveda Fertility Company, Expands Reach with New Clinic in Pune, Set to Open 100 Clinics Across India by 2027May 03, 2024
Aptus Value Housing Finance India Limited, a leading Housing Finance Company has declared its financial results for the year ended March 31, 2024. FY 24 ResultsMay 03, 2024
TIPS FOR PREGNANCY CARE DURING SUMMERMay 03, 2024
The deadly intersection: TB and tobacco smoking co-epidemics in Indonesia Dr TARA SINGH BAM – CNSMay 03, 2024