Senior R&D Team
Brahmaiah Vallabhaneni, M Sc
Head, Analytical R&D
He has over 10 years of experience in Analytical Research and Development of various finished dosage forms and APIs. Prior to joining airis PHARMA, he had worked with companies such as Aurobindo, AET Laboratories, Ratio Pharm, Finoso Pharma and Appcure Labs. He has in-depth knowledge and experience in method development, method validation, method transfer, laboratory management, and stability studies. He is an expert in handling wide range of analytical instruments including HPLC, UPLC, DSC, GC with TCD and ECD, Laser Diffraction Particle Size Analyzers, UV, and FTIR. He has developed and validated analytical methods for assay, related substances, and dissolution for diverse dosage forms like capsules, pellets, tablets, injectables, and suspensions for filing of ANDAs, monograph, and in-house products. He has interacted with US, UK MHRA, Health Canada, and other leading agencies.
He holds a Bachelor’s Degree in Science from Nagarjuna University, Guntur, India and M.Sc. in Analytical Chemistry from SRTM University, Maharashtra, India. He is currently pursuing PhD. in Analytical Chemistry from Dravidian University, Tamil Nadu, India.
Dr. Ramesh Kannuri, M Pharm, PhD
Head, Formulation R&D
He has about a decade of strategic expertise in the drug product development of different dosage forms towards ANDAs and in the development of non-infringing processes (505(b)(2), FDCs) for the regulated global and emerging markets. Prior to joining airis PHARMA, he had worked at Hospira, and Hetero Labs in the formulation R&D. He has diverse experience that encompasses activities from formulation development to product approvals for the US, Canada, Europe, and other regulated markets. He had managed product development programs and scientific teams from initiation, development strategy, risk assessment, non-infringement analysis and regulatory filings towards the delivery of highest quality generic products. He has thorough knowledge of formulation design and development, technology transfer, CMC regulations, project & portfolio management, team building, and mentoring.
He holds PhD from Andhra University, India and has Master’s from Annamalai University, Tamil Nadu, India and Bachelors degree from JNT University, Hyderabad, India. He also has a Post Graduate diploma in Patent Law from NALSAR University, Hyderabad, India.
Chander Kazipeta, M Pharm
Head, Global Regulatory Affairs
He has over 10 years of regulatory experience in the development of generic products for USFDA, EU, TGA, MEDSAFE, MCC, and ROW markets with companies such as Mylan, Actavis, Strides Arco Labs, and Anglo-French Drugs. He has experience in ANDA and MAA through DCP, MRP, Re-peat MRP application process in paper or electronic (eCTD), Nees (Non-eCTD) formats including various modules. He has worked on nearly 260 submissions to various health agencies through eCTD and paper formats. He has experience in the design and implementation of regulatory documents pertaining to diverse dosage forms. He has expertise in the strategic filing of ANDAs and MAA through DCP, Re-MRPs to meet day 1 launch for first to file products in the US and EU markets. He also is well versed with post-approval changes for different markets.
He has B. Pharmacy from Kakatiya University, Warangal, India and M. Pharmacy in Industrial pharmacy from Annamalai University, Tamil Nadu, India.
Koushik Rajaram, M Pharm
Head, Quality R&D
He has over 15 years of experience including 6 years in the managerial capacity in quality assurance in companies such as KAPL, Aurobindo Pharma, Medreich, and Fourrts. He successfully has led various audits and inspections from WHO GMP, IDMA quality awards, customer and third party audits, and audits from African countries’ regulatory agencies. He also has interacted with USFDA, UKMHRA, and ANVISA. He is well versed in the qualification and validation of processes and equipment, and utilities related to diverse dosage forms such as tablets and powders, hard and soft gelatine capsules, oral liquids, and lotions. He is experienced in the training and implementation of cGMPs, in pre-audit preparations, management of audit processes and in post audit activities.
He has B. Pharmacy from Kuvempu University, Karnataka, India and M. Pharmacy in Pharmaceutics from Dr. MGR Medical University, Tamil Nadu, India.