About Us About Us

Simson Pharma is a major Indian exporter dealing with Certified Reference standards, Research chemicals, Metabolites, Isotope labelled compounds and Traceable working standards in The United States of America. Our speciality lies in developing custom synthesis of complex organic compounds and intermediates, reference compounds, custom peptides and amino acids. All supplies to US pharma firms include production of APIs, Impurities, Metabolites and Stable Isotope Compounds. Our pioneering methodology has resulted in becoming a reputed manufacturer of Complicated Impurity Standards. We are a highly reliable and complete solution provider in identifying, synthesizing and qualifying any Unknown Impurity. For all verification and validation, we follow FDA and its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

Our State-Of-The-Art Facility

We have a state-of-the-art facility for custom manufacturing catering to clients based in the US. The workforce is constantly engaged in production of APIs, Impurities, Metabolites and Stable Isotope Compounds. They have an in-depth knowledge of a complex variety of chemical reactions. This is why we are able to deliver what we commit for developing a long time relationship. The R&D center and Analytical lab facility reduces the delivery timeline to benefit the client.

We are Your Trusted Partner

Our team partners with companies related to the US bio-medical and pharma industries. They utilize various expertise to accelerate pharma work in diverse research areas. Both drug discovery and its development are important to us. By supporting our clients’ business, we are considered as responsible service providers. We offer consultation and actual manufacturing for pilot/kg for scaling the production. When it comes to sourcing pharmaceutical products, trust and certification are paramount. At Simson Pharma Limited, we are proud to be your reliable partner for certified pharmaceutical supplies in the USA. Our commitment to quality and compliance ensures that you receive only the best products for your needs. “ Certification Assurance-Quality is essential to our business “ SImson Pharma USA meets all the guidelines for exports to the USA. Before entry into the country, we ensure we have the necessary certification. Every compound produced in our plant is certified with COA. It also includes the complete structure elucidation and data interpretation. We use high-end analytical techniques like NMR, MASS, IR, TGA, CHNS and Chromatographic purity. Working for numerous years, we have a comprehensive inventory of more than 15,000 products. Our services target:

  • Synthesis of stable isotope labelled analogues 
  • Building blocks 
  • Intermediates 
  • Nucleic acid derivatives 
  • Metabolites and impurities
  • Standardised reference compounds

Simson Pharma USA provides high-quality and cost-effective organic synthesis services worldwide. 

From Custom Synthesis to Analytics: How We Address Your Unique Need

  1. Verification of synthetic route and timeline establishment.
  2. Product development. 
  3. Troubleshooting. 
  4. Product confirmation by analytical methods, MSDS, COA with SER data 
  5. Packaging.

As a priority, we meet safety factors, identity, strength and purity standards that meet the border laws for export.  

Analytic services with QC

  • Provision of certification with chemical analysis for Reference Standards.
  • Analysis for NMR, Mass spectrometry, Elemental and IR.
  • NMR
  • HPLC/LCMS/GC
  • TGA / LOD
  • Determination of water content
  • NMR or GC residual solvent content 
  • Isolation of impurities and any degradable products.
  • D0 content for stable isotope compound

Have questions or need assistance with doing business in the USA? Our team of experts is here to help. Reach out to us today for personalized support and detailed information.

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