Dr. Balkrishna Khanderao Kulkarni is a M. Sc. From Fergusson College, Pune & Ph. D from Pune University with an Industrial Experience (35 years) in Sanofi, Targos Pure Drugs, Innovassynth Technologies etc…

He has 11 filed Publications in International Scientific Journals based on the doctoral research work.3 Publications and 1 patent during the tenure in Hoechst 1 US Process Patent in Innovassynth. During doctoral research, he has also worked on a Maharashtra Govt. sponsored project namely, ‘Isolation of Anticancer compounds Vinblastin & Vincristine from Vinca Rosea’.

List of Accomplishments:

• Played a major role In Technology transfer, setting up the facility and manpower recruitment, commissioning and stabilizing the production of a Specialty Chemical on commercial scale for Innovassynth in collaboration with M/s Ciba Specialty Chemicals, Switzerland ( now taken over by BASF, Germany)
• Introduced the concept of Custom Synthesis & Contract Manufacture.
• Played a significant role in shaping up this company and bringing it up to the current stature.
• Developed Business and introduced potential customers from various counties, mainly from America, Canada, Europe and Japan to the company.
• Marketing efforts involved attending various trade shows, meeting customers, taking new projects (challenges), cracking the chemistry processes with the R&D team members, scale up and commercial production.
• The efforts have resulted in creating a large chemistry data base for the company and many international customers are in the fold of this company.
• He played an instrumental role to work and produce many Nucleoside products, which are being used by many research companies globally in developing new generation gene-based drug therapy as well as in Diagnostics.

Experience :- 25 Yrs. in Pharmaceutical, Manufacturing and Research

Expertise :- API, Intermediates, Peptide API, Peptide Formulation , Subject matter expert (SME) Global

PROJECTS :-

• Liraglutide Exenatide ACTH Degarelix Calcitonin etc --Peptides (25+)
• Tramadol HCl Chlorhexidine B Diacerein Aloe-emodin etc --Gen API (5)
• Thiadiazols Oxadiazol Triazolenedione Bisphosphonates --CRO (30+)
• Peptide formulations, subcutaneous and sustain release (Depot) –Leup. Octretide (3)

AUDITS AND COMPLIANCE :-

• USFDA-2016, Swedish MPA audit (2016), WHO-GMP (2015), Korean FDA (2014)
• Indian FDA (2015), CDSCO –India (2016), EDQM Approval
• Customer audits, International (8) US, EP (Ferring, Peptron, Eriochem, Tolmar, Chiasma etc.)
• Customer audits, Domestic (~10) (DRL, SUN, Glenmark, CIPLA etc.

Experience :- 37 Yrs. in Batch and Continuous Manufacturing Operations, Technology transfer, New Project Execution and Production startup.

Expertise :- Bulk Drug, Specialty Chemicals, Chiral Compounds and Iodine based derivatives.

PROJECTS :-

• Performed complex reactions involving Iodination, Bromination, Diazotization, and Reduction by different chemistry. (35+)
• Member of ESHA & Safety Committee and undertook several safety audits.
• Improving the plant efficiency and cutting down costs by about 20%
• Developed technology to reduce the effluents and reducing the carbon footprints.

Harsh Trehon is a veteran in International Business & Marketing of API’s & Intermediates.

He is a qualified M.B.A in International Business

He has a great hands-on experience of working with Pharma companies Globally.

• Started my carrier in 1989 as part of Ranbaxy Lab
• 1995 till 2010 was with Emcure Pharma Ltd.
• He then joined Marksan’s Pharma & was Elevated to Sr. Vice President.
• He later was a Part of Theon Pharma as President International Business.
• Teaching faculty in pharmacy and MBA college like NMIMS.
• International teaching faculty by Nepal, Thailand, Malaysia and Indonesia for guest lectures.
• Part of SPER [Society of Pharmaceuticals Education & Research]