Nuray Chemicals Pvt Ltd is a pharmaceutical company founded in 2013 by Muthusamy Shanmugam with over 30 years of industry experience. The company has 188 employees with expertise in research and development, analytical development, quality control, production, and regulatory affairs. Nuray has capabilities for developing APIs and intermediates across various therapeutic areas. It has state-of-the-art facilities and equipment for R&D, analytical testing, kilo lab, pilot plant, manufacturing, and quality assurance. Nuray has successfully completed three US FDA audits and has over 15 DMF filings with global regulatory agencies.
Nuray Chemicals Pvt Ltd is a pharmaceutical company founded in 2013 by Muthusamy Shanmugam with over 30 years of industry experience. The company has 188 employees with expertise in research and development, analytical development, quality control, production, and regulatory affairs. Nuray has capabilities for developing APIs and intermediates across various therapeutic areas. It has state-of-the-art facilities and equipment for R&D, analytical testing, kilo lab, pilot plant, manufacturing, and quality assurance. Nuray has successfully completed three US FDA audits and has over 15 DMF filings with global regulatory agencies.
Nuray Chemicals Pvt Ltd is a pharmaceutical company founded in 2013 by Muthusamy Shanmugam with over 30 years of industry experience. The company has 188 employees with expertise in research and development, analytical development, quality control, production, and regulatory affairs. Nuray has capabilities for developing APIs and intermediates across various therapeutic areas. It has state-of-the-art facilities and equipment for R&D, analytical testing, kilo lab, pilot plant, manufacturing, and quality assurance. Nuray has successfully completed three US FDA audits and has over 15 DMF filings with global regulatory agencies.
Nuray Chemicals Pvt Ltd is a pharmaceutical company founded in 2013 by Muthusamy Shanmugam with over 30 years of industry experience. The company has 188 employees with expertise in research and development, analytical development, quality control, production, and regulatory affairs. Nuray has capabilities for developing APIs and intermediates across various therapeutic areas. It has state-of-the-art facilities and equipment for R&D, analytical testing, kilo lab, pilot plant, manufacturing, and quality assurance. Nuray has successfully completed three US FDA audits and has over 15 DMF filings with global regulatory agencies.
• Developed and Commercialized in excess of 100 specialty dosage forms
Muthusamy Shanmugam ( SAMY) • Have professional experience in companies like Ivax, Kali Labs, Par Founder Promoter & CEO Pharmaceuticals, Novel Labs, in USA M. Pharm with 3 decades of Industry experience & first • Masters degree in Pharmacy and registered pharmacist in the State of NY generation serial entrepreneur
J.Jayaseelan • Pharmaceutical entrepreneur with a successful track record
B. Pharm., MBA • Affiliations include various honorary Positions held such as
Renowned pharma Chairman- Indian Drug and Manufacturer Association (IDMA)
entrepreneur Secretary – Indian Pharmaceutical Association (IPA) Govt. Nominee in Pharmacy Council of India Overview
2nd Commercial 3rd successive successive operations USFDA audit USFDA and approval audit and Feb 2015 June 2018 approval
Nov 2013 Jan 2016 Dec 2017
1st US FDA approval 15 USDMF, 2 EDMF and 1 TGA & New Zealand DMF Key People Dept. Experience Company Dr. G. Panchapakesan Operations & Research 28 yrs Orchid Chem. & GVK Bio Dr. N. R. Kandasamy Quality System 35 yrs Novitium -USA, PAR & Shasun Dr. M. Balasubramanian Production and SHE 25 yrs Orchid Chem, Aurobindo Dr. K. Ravi Project Management 15 yrs Modepro Dr. R. Venkatragavan Research & Development 16 yrs Syngene & GVK Bio Dr. N. Balaji Analytical Development 15 yrs Dr. Reddys & Apotex Mr. S. Milan Quality Assurance 13 yrs Sun Pharma & Malladi Mr. D. Thirumoorthy Quality Control 14 yrs Wockhardt, Orchid and Kudos Mr. D. Kotaiah Regulatory Affairs 10 yrs MSN, Nutra Specialities Mr. M. Prakash Engineering 28 yrs Aurobindo & JK Pharma Mr. S. Abdul Rahaman HR & Admin 18 yrs Aurobindo Mr. J. Gnanam Supply chain 19 yrs PAR, Orchid and Sanmar
Total Headcount 24 26 39 44 22 11 22 188 R&D ARD QC Production Engineering QA/RA Other functions Research & Development Equipped with 28 fume hoods
Capable of developing eco-friendly, non-infringing
robust processes for API’s.
Experienced in all therapeutic areas like
prostaglandins, Steroids, Nucleosides etc.
Handling of all diversified reactions especially Stereo
specific, Stereo selective and Chiral resolutions.
Dedicated team for impurity preparations, technology
transfer, cost reduction, intellectual property
evaluations and to address DMF deficiencies.
Skilled scientists to develop novel polymorphs
Analytical Development Capabilities • Robust Method development, validation and method transfer • Stability study of bulk drugs and intermediates • Kinetics and mechanism of degradation of bulk drugs and intermediates • Structure elucidation and characterisation of API’s and intermediates • Impurities isolation by Prep. LC • Multi-nuclear NMR-1(400 MHz) • HPLC – 21 Preparative HPLC - 1 • LCMS – 1 GCMS -1 • GC – 2 UV -1 • DSC -1 IC - 1 Quality Control Infrastructure • HPLC – 6 GC – 4 • UV - 1 FTIR – 1 • Stability Chambers – 5 • Photo Stability Chamber -1 • Malvern – 1 Quality Assurance
Successfully completed
• US-FDA audits - 3
(2015, 2016 & 2017)
• QP audits - 2
• More than 20 customer audits
• More than 5 third party audits
• WHO-GMP from CDSCO
Microbiology Lab standards
• LAF room – 1 • Bio safety Cabinet – 1 • Autoclave – 2 • Incubators – 4 • Microscope – 1 • Colony counter – 1 Production Production block viz.,
• Separate Raw material storage area for • Solids • Liquids • Packing materials • Hazardous chemicals • Separate finished API storage area for • Controlled room temperature (20-250C) • Cold room temperature(2-80C) Utilities Infrastructure
