Chemical synthesis is an essential part of drug development. However, the number of technical and managerial tasks involved in the process – many of which prove to be "one-off" operations - can serve to hamper the overall effectiveness of the research team. Outsourcing the activity is an efficient, cost-effective means of ensuring the smooth and timely passage of new drug compounds through the pipeline.
RXN CHEMICALS PVT LTD. offers a full range of services in custom organic synthesis. At RXN, we provide to our Customers/ Clients a range of in house synthesized products including Building blocks, Scaffolds, Intermediates, Reference/ Standard compounds, Specific API, Intermediates and Impurities in our state of the art facility located at Navi Mumbai, wherein we undertake small scale synthesis (in mg) to large scale synthesis (in kgs). Our synthetic team is trained to take any kind of challenges in synthetic organic chemistry involving various types of chemistry viz. heterocyclic, asymmetric, enzymatic and multi-step synthesis of organic compounds to deliver product as per the client’s needs. We also support medicinal chemistry projects for reputed pharmaceutical company.
At RXN CHEMICALS the scientist are trained and equipped to develop new methodologies to overcome challenges and deliver products/ compounds on required timelines without any compromise on quality. The synthesis team is trained to take care of any kind of challenges in synthetic organic chemistry involving various types of chemistry viz. heterocyclic, asymmetric, microwave, enzymatic and multi-step synthesis to deliver products/ compounds as per customer/ client needs. We supply materials ranging from milligram to kilogram scale.
The main advantages that we provide to our Customers / Clients are:
- High efficiency and excellent quality
- Competitive price
- Within required timelines
- Experience in synthesis of complex and multi-step processes
- Small scale synthesis up to 1 gm
- Medium scale synthesis from 1 g to 100 g
- Large scale synthesis from 100 g to 1 kilogram
- Final product/ intermediate well characterization using our state of the science analytical facility (NMR, HPLC and LC-MS)
- Transfer of process technology to pilot plants for advanced molecules
An impurity in a drug product, that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and thedrug product, is any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. The existence of these impurities even in trace amounts may influence the efficacy and safety of the drug product. Therefore, identification and characterisation of impurities called Impurity Profiling is now becoming significant critical product quality parameter and getting critical review from regulatory authorities.
International Conference on Harmonization (ICH) has published guidelines for validation methods for analysis of impurities in new drug products, new drug substances, residual solvents & microbiological impurities for registration of pharmaceuticals.Most active pharmaceutical ingredients (API) are produced by organic chemical synthesis. Various components, including residual solvents, trace amounts of inorganic, and organic components can be generated during such a process. Those components remaining in the final API are considered as impurities.
RXN CHEMICALS PVT. LTD. offers a wide range of high purity Impurity Standards for the pharmaceutical industries on milligram to gram scale at competitive price. We have a technical capability to synthesize, isolate and purify the Impurity Standards to their purest form. We also offer custom synthesis of impurity compounds as on requests.
A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be compared. Drug reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators. They are explicitly required in many Pharmacopeial assays and tests done by any Pharmaceutical Company and are provided solely for such use. The quality and accuracy of reference Standard are essential to the manufacture of quality medicines and foods.
RXN CHEMICALS PVT. LTD. supply a wide range of high quality drug reference standard supported with analytical data.
Active Pharmaceuticals Ingredients:
An active pharmaceutical ingredient (API) is the ingredient in a pharmaceutical drug that is biologically active. The purity requirement of an API is emphasized by various regulatory authorities such as the International Conference on Harmonization (ICH), the United States Food and Drug administration (FDA), and the Canadian Drug and Health Agency (CDHA) as it may affect the efficacy of the pharmaceutical drug.
RXN CHEMICALS PVT. LTD. offershigh quality of pharmaceutical Active ingredients at competitive price to quite a lot of companies all over the world. We supply the material from our FDA approved plant as well as variety of Indian good manufacturing facilities, approved by various regulatory bodies like; Japan, Korea, Europe,Australia & USA.Our APIs product portfolio consists of more than 100 molecules catering to needs in various therapies. These includes Anti-Infectives, Cardiovascular, Anti—Diabetic, Anti-Ulcerative, Antibiotics, Anti-hypertensive, Antipsychotic, Antitubercular, Anti-inflammatory, Anti-Cancer, Anaesthetic, Anti-Asthmatic, Antidiarrhoeal, Antidepressants, Antifungal, Antiparkinson, Erectile Dysfunction, Urological, Ophthalmic, etc.
Rxn chemicals has gain respect as one of India's leading exporters of APIs with almost 40% of the turn over coming from APIs having predefined Regulated and Non-Regulated markets. Our export mostly goes to countries such as USA, Canada, Europe and Australia.We work hard in supplying best quality of APIs, constantly working closely with our manufacturers to offer products which can meet up the International standards of Production, Technology and Quality Assurance.