Mr. Kumar Shanmugam holds a postgraduate degree in Pharmacy, specializing in Pharmaceutics, from Birla Institute of Technology, Ranchi, India.
Mr. Kumar Shanmugam started his career as formulation development scientist in Torrent Research Centre where he obtained experience in various formulations including solid orals, powder for oral solution/suspension, liquid orals, injectable and semisolids.
Mr. Kumar Shanmugam went on to work in various companies in India, which include Ranbaxy Research Labs, Mylan Labs, Dr. Reddy’s Lab, Orchid Healthcare and Par formulations. He is well versed with designing formulation strategies, which are stable, bioequivalent and non-infringing to patents.
Mr. Kumar Shanmugam has 20 years experience in Formulation Development and Technology transfer. He has rich experience in formulating complex molecules to overcome stability and BE challenges predominantly for registration with US and EU markets. He also has rich experience in scaling up formulations from lab scale to pilot, and pilot to commercial scale manufacturing.
Mr. Kumar Shanmugam was a key member in internal audits and FDA and MHRA audits. He is well versed with the current guidance and regulatory requirements for US and EU markets.
P.Kanteepan Ph.D. - Vice President
Mr. P.Kanteepan, Ph.D., has 17 years experience in formulation R&D. He has worked in companies such as Sun Pharma, FTF Pharma, Piramal, Aurobindo Pharma and Caplin Point in India.
Mr. P.Kanteepan was previously heading R&D for sterile product development for regulatory and semi regulatory markets.
Mr. P. Kanteepan has a wide range of expertise in developing inhalation products (DPI), sterile products, oral solutions, topical solutions and semisolid dosage forms through NDA, ANDA and NP and DCP in Europe.
He has to his credit 5 patents which he filed during the development of 505 b (2) products. He has developed about 100 products for US, EU, Australia, Canada and ROW markets. He also has been involved in the development of NCE – Injectable for anti-cancer and anti-biotic therapeutic categories.
Bhaskar G N– Manager (Analytical)
Mr. Bhaskar holds an M.Pharm degree and has 11 years of experience in USFDA and MHRA approved pharmaceutical companies (handled Analytical Method Development, Stability). He has sound experience in analytical method development meeting global regulatory requirements. He was previously associated with R&D at Par Formulations and Apotex Research Pvt Ltd.
He was previously associated with R&D at Par Formulations and Apotex Research Pvt Ltd.
He is skilled in method development for in-vitro bioequivalence studies, specifically phosphate binding studies.
He has sound experience in analytical method development meeting global regulatory requirements.
He is well versed in development of stability studies as per ICH guidelines.
He is experienced in handling regulatory queries pertaining to analytical method development and validation by USFDA, MHRA, and TGA.