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

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