| |AUGUST 20248RUSAN PHARMA'S API PLANT IN ANKLESHWAR BAGS USFDA GMP APPROVALMHRA APPROVES FIRST GENERIC RALTEGRAVIR MEDICINES FOR HIV TREATMENTRUSAN PHARMA a pharmaceutical company headquartered in India that focuses on addiction treatment and pain management, has just confirmed that its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India) has received Good Manufacturing Practice (GMP) approval from the United States Food and Drug Administration (USFDA). The authorization, granted on May 29, 2024, came after a thorough five-day inspection carried out on site from April 29 to May 3, 2024.This significant milestone sets the company up to enter the US API market. Having an operational US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, Rusan Pharma intends to enhance its collection with more APIs like Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam.Speaking on the achievement, Dr. Kunal Saxena, Managing Director of Rusan Pharma, highlights, "This GMP approval by the USFDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards."The approval of the Ankleshwar facility by the USFDA is a crucial step in Rusan Pharma's plan to establish itself as a major player in the worldwide pharmaceutical sector. At the moment, the company provides APIs to multiple American companies specializing in orphan drugs, addiction treatment, and obesity medications. The authorization will further improve Rusan's abilities, broaden its API product range, and expand its presence in the expanding US pharmaceutical industry. POThe first generic raltegravir medications for treating adult and pediatric HIV patients weighing at least 40kg have been authorized by the UK Medicines and Healthcare products Regulatory Agency (MHRA). HIV is responsible for AIDS, which is a syndrome that weakens the body's immune system. HIV creates a protein called HIV integrase that allows the virus to replicate in cells in the body.Both pharmaceutical firms Lupin Healthcare (UK) and Zentiva Pharma UK were granted a new marketing authorisation on July 19, 2024.Raltegravir inhibits the enzyme's activity, potentially lowering HIV levels and boosting CD4-cell count when combined with other medications. Lowering HIV levels in the bloodstream could enhance immune system performance, enabling the body to combat infections more effectively.Raltegravir, the active component, is a antiviral medication administered in the form of a 600 mg film-coated tablet. The prescribed amount of medicine is 1,200 mg to be taken orally once daily, in the form of two 600 mg tablets. Raltegravir should be administered alongside other medications for HIV treatment.Shirley Hopper, MHRA deputy director of Innovative Medicines, added: "Ensuring timely access to generic medicines is a key priority for us."Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with an already licensed reference medicine, called Isentress. POTOP STORIES | |AUGUST 20248
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