• Phone: +91 9881760231
  • Email: bd@jisaipharma.com


About us

Leadership

Dr. B. Sreenivasa Rao, is the Key promoter of the organisation and holding the role of whole time Director and Chief Executive Officer.
Dr. Rao has a Ph.D. in Chemistry and having a rich experience of over 23 years in the pharmaceutical industry with expertise in drug discovery research, process research, development of Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs), custom chemical synthesis, contract research and manufacturing. He has the experience of working with multiple customers spread across various geographies both in India and abroad. He has worked with some leading and marque customers based in USA, Europe, Japan, Israel and supported their critical projects.

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Facilities

We are located at Indian Pharmaceutical hub of Hyderabad. The R&D is well equipped to run all types of chemical reactions like cryo reactions, hydrogenations, high temperature reactions etc. HPLC, GC and other associated instruments are available in AR&D.

Products

APIs

Sitagliptin Phosphate

Saxagliptin Hydrochloride

Teneligliptin Hydrobromide Hydrate

Alogliptin Benzoate

Linagliptin

Vildagliptin

Anagliptin

Rivaroxaban

Aripiprazole

Capecitabine

Cabozantinib

Lasmiditan hemisuccinate

Services

Chemical Development Services

We take-up NCE development for the customers with value addition on quality, pricing and robust technology development. We have expertise right from route scouting, Process Development, scale-up to commercial scale of NCEs of preclinical and clinical phase molecules.
Chemistry expertise:
Our Process R&D team has expertise in developing and scaling up of multi step processes for complex chemistries like, heterocyclics, carbohydrates, organometallics, nucleosides, Polysaccharide chemistry with high molecular weight like 5000 Daltons ( Enoxaparin, Pentosan ) etc.

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APIs & Intermediates

We take up extensive process research and development right from route selection, process research using QbD approaches and ICH Q11, gentoxic evaluations as per ICH M7, control strategy, Product development reports, process safety evaluations, scale-up/ pilot plant trials, analytical method validations. Technology transfer to the GMP locations, Process validations, DMF filings, regulatory responses and commercial manufacturing. We provide the services & Strategic partnership for development, Validations, DMF filing and commercial manufacturing of APIs and Intermediates of APIs. We are flexible in our business model to support various clients.

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Scientific Regulatory Services

We do onsite visits to provide the scientific and regulatory services to customers for developing new products for regulated markets, resolving the scaleup issues in GMP and proving the CAPAs appropriately. We also undertake the Drug Master Files (DMFs)/CEPs preparation and Submission to respective regulatory agencies like USFDA, EDQM and PMDA, KFDA etc. We also do the gap analysis of existing DMFs, corrective actions and submitting the final DMFs to agencies. We also provide the regulatory query responses scientifically to get DMFs/CEPs approval/acceptance from regulatory agencies.


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