Mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants in combination with other immunosuppressants.
Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes. MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28. MPA decreases proliferative responses of T- and B-lymphocytes to both mitogenic and allo-antigenic stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes such as GM-CSF, IFN-Ɣ, IL-17, and TNF-α. Additionally, MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Overall, the effect of MPA is cytostatic and reversible.
Rakshit is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) through our manufacturing sites in Hyderabad and Vizag. Our API facilities have been inspected and approved by different international regulatory bodies including the US FDA, Japan PMDA, KFDA, TGA and meet the cGMP standards. We have sustainably evolved as one of the fast growing organization in the pharmaceutical industry in India. To cater to market requirements, we have dedicated our 6 manufacturing facilities to our core business area – APIs ably supported well-equipped Research & Development laboratory both for process improvement and new product development.
We have been successfully supplying APIs all over the globe for more than Two decades. We are capable of executing extensive API requirements for our customers. Rakshit has an experienced team of skilled employees, who are equipped for API manufacture with adequate care. We have a stand-alone R&D center located in Visakhapatnam with State-of-the-art analytical facilities and around 100 employees. We have wide variety of products in diverse therapeutic segments.
Some of the Active Pharmaceuticals Ingredients (APIs) mentioned in the Rakshit’s product list or brochure or in the product list uploaded in Rakshit’s website may be protected by a valid patent in India or in any other countries concerned. However, mentioning of the name of such product(s) in the product brochure or the product list shall not be construed as infringement in any manner whatsoever. Without prejudice to the foregoing, Rakshit’s supply of API being protected by a valid product patent, if any, is intended solely for uses reasonably relating to the research and development, and regulatory submission under any law for the time being inforce, in India, or in a country other than India that regulates the manufacture, use, sale or import of the said product, strictly under the conditions as set forth in Section 107A of the Indian patents Act, 1970, as amended in 2005, or an equivalent provision (Bolar exemption) thereof in a country other than India. The disclaimer is applicable till the expiration of the corresponding product patent(s), if any, in the respective countries concerned. None of the products will be supplied to the countries wherein this could be in conflict with existing laws. However, the final responsibility lies exclusively with the buyer/end customer
