R&D is the lifeblood of J. B. Chemicals & Pharmaceuticals Ltd..
Our R&D efforts have so far yielded 18 International Patents and
our scientists have discovered 20 New Molecules in NSAID therapeutic
segments.
Two state-of-the-art R&D laboratories at Mumbai & Ankleshwar
match superior standards. |
Focus:
Our current and future R&D activities will focus on development of
Generic Products for Regulated Markets.
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J. B. Chemicals & Pharmaceuticals Ltd. can deliver following package
as a total Drug Product development:
- Formulation Development
- Analytical Development
- Scale up batches
- Pilot / ANDA /ANDS / Submission batches
- Bio-study
- Dossier Compilation
- Validation batches
- Commercial Production
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Technical Capabilities of R&D
- Solid dosage formulations such as Tablets, Capsules, pellets.
- Injectables
- Dental preparations
- Ophthalmic preparation-solutions, Suspensions, Gels, Ointments
- Dermatologicals – Gels, Creams, Ointments.
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GMP facilities for solid dosage forms & Parenterals.
- Labscale (R&D)
- Pilot Facility
- Commercial Production
All equipment for above mentioned facilities are from the same SUPAC
category to facilitate the Scale up exercise & commercial production
at Panoli Site, Gujrat. |
Novel Drug Delivery Systems (NDDS) efforts concentrate on:
Controlled Release: Our research concentrates on sustained, delayed
and pulsatile release. The company introduced a Novel Insoluble Drug
Absorption Technology (NIDAT) for Nicardia CD and has also received
a patent for Ranitidine controlled release tablets in U.S.A. and Nifedipine
sustained release tablets in South Africa and Kazakhstan.
Novel Dosage Formulations: In the novel dosage form, the company concentrates
on following therapeutic segments covered by NDDS
- Cardiac Care
- Anti-infectives
- Anti-diabetics
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Abbreviated New Drug Application (ANDA)
The company's ANDAs filing received a fillip after a JV was signed
with Spectrum Pharmaceuticals Inc USA ( formerly known as NeoTherapeutics).
The company will be filing three to four ANDAs to address the growing
opportunity in the U.S.A in the anti-infectives and anti-fungal areas.
- Company has filed two ANDAs and about 4 more to be filed in
the next year.
- The Commercial Production site has been approved by USFDA.
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Herbal Products
The company focuses on specialty natural herbal formulation
the following products: Fitovit - Herbal Fitness Capsules, Zecuf-
similar to Doktor Mom, launched in India, and Doktor Mom Lozenges
- in Five New Flavours (pineapple, strawberry, raspberry, lemon and
orange) launched in Russia.
R&D plays a vital supportive role for other corporate functions
as well such as quality assurance, regulatory affairs and intellectual
property rights issues.
A team of dedicated doctors and research scientists are continuously
working towards breakthrough and development of new products and processes.
Validation team from all concerned departments successfully transfers
the drug product from R&D to Commercial Production.
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New Chemical Entities (NCE)
The company's initiative in the NCE segment bore fruit following the
discovery of the possible COX 2 inhibitor in the anti-inflammatory
segment. The company has invented 20 new molecules for patents and
has been granted the patent. Pre-clinical studies have begun for the
three prioritized molecules. |
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| R & D Milestones
| Quality |
Technology | Patents |
