Active Pharmaceutical Ingredient (API) is a substance in a finished pharmaceutical product, which has a pharmacological activity or is responsible for generating a direct effect in the diagnosis, treatment or prevention of a disease.
Emcure is recognized as the pioneer in chiral chemistry. It has effectively developed and marketed 11 chiral molecules which have demonstrated greater effectiveness, safety and require lesser dosage than their non-chiral counterparts. Examples: S(-) Amlodipine Besilate, S (-)Metoprolol Succinate, Dexrabeprazole Sodium, S(-) Etodolac, Dexketoprofen Trometamol.
What is chirality? In chemistry chirality a molecule will have 2 forms that are mirror images of each other but otherwise identical. These mirror images are non-superimposable on each other. In chemistry terms these are known as enantiomers. This is the simplest form of chirality.
The following video is a useful illustration on chirality.
Pharmacology responds differently to chiral molecules in a lot of cases and thus having a chiral version of a certain biological agent is considered beneficial in most cases.
What are some advantages of a chiral drug?
Why studying stereo-chemical features are important?
Emcure’s focus of research in this area involves both solid & solution phase peptide synthesis chemistry. The most critical segment of peptide research is the high-end separation of peptides in order to ensure their structure, purity and potency is maintained. Emcure has perfected the science of separation of peptides at manufacturing scale by implementing state- of- art technology along with the development of high-end skill set
What are peptides?
Peptides are intrinsic signaling molecules for various pharmacological processes. Off late they have become a corner stone for therapeutic intervention. Peptide drugs are complex in nature primarily due to challenges in characterizations and synthesis. As the chain length increases these challenges multiply many-fold.
Approved peptides span a wide therapeutic domain. From preterm labor (Autosiban) to erectile dysfunction (aviptadil) to the drug class of “tide” (dulaglutide, exenatide, etc); the therapeutic span is vast. Some of these drugs live aviptadil has been repurposed for covid19 too.
Synthetically peptides drugs can be assembled via a solution-phase strategy or a solid-support strategy.
An illustration of solid phase synthesizer can be viewed via the following link:
Owing to their complex structural parameters, these products require unique process maneuvering. Also, the characterization and bioequivalence studies require sophisticated spectroscopic and biochemical analysis. All these requirements have been built in- house to ensure safety and efficacy of complex generic APIs.
Emcure has always been a market leader in onco-products for both domestic as well as other regulated markets. Keeping that commitment to the patients in mind, it has been able to develop extremely complex APIs entailing multi-step transformation and concomitant generation of chiral centers
Emcure is a market leader in iron- based products. Iron products need complex characterization techniques and require niche skill set to achieve desired quality. Emcure’s analytical research department has been able to master these skills to deliver such complex generics for the customers. As a result, products such as Iron-sucrose, Ferric-carboxymaltose and Iron ascorbate have been made available to patients
Emcure has developed expertise in manufacturing ARV APIs while improving cost efficiencies to make them available at affordable prices. It has successfully commercialized products such as Atazanavir, Ritonavir, Dolutegravir and Tenofovir
Emcure has developed expertise to deliver complex generics via phytochemical transformations. Delivery of these products needs customized reactor design with intricate photochemical reactor design. These products can only be delivered with mellifluous integration of state- of- art engineering and complex chemistry which Emcure has mastered over the years. Example: Dydrogestrone
Photochemical reactions are a set of reactions that uses any form of light energy for a transformation. This can be infrared, visible and or ultraviolet light. Nature uses light source for various transformations. Few common examples are photosynthesis in plants, vitamin D synthesis in humans, conversion of oxygen to ozone in the stratosphere, etc.
Photochemistry can be efficiently used to synthesize various chemical matter, especially drug candidates like steroids, vitamin D derivatives, etc.
Emcure has a dedicated state-of-the-art facility for the production of Immunosuppressant API. The segregated area for manufacturing immunosuppressant products API has minimum personnel intervention with a high degree of isolation. It has developed molecules such as Fingolimod and Mycoplenolate