Jubilant Life Sciences to market generic antidepressant
December 21, 2015: The globally renowned Jubilant Life Sciences has continuously been in the forefront of research, and the development of novel medical products. This pharmaceutical organization’s forte is in the manufacture of APIs, solid dosage forms, radioactive isotopes, and radiochemical diagnostic aids. Jubilant Biosys is their recent foray into drug discovery and biotechnology, which has already borne fruit. Based in Bengaluru, Jubilant has a talented team of scientists in their research facility, which enables these breakthroughs.
Jubilant’s most recent achievement has been obtaining USFDA approval for Paxil tablets. Paroxetine, drug candidate is prescribed as an anti-depressant, and currently Apotex’s version is dispensed in strengths of 10 mg, 20 mg, 30 mg, and 40 mg tablets.
Antidepressants are drugs that are not only used in major depressive disorders, but also in conditions such as obsessive compulsive disorders, eating disorders, neural pain, ADHD and certain kinds of addictions. These are conditions which often lead to depression in the long run. Treatment options include tricyclic and/or tetracyclic antidepressants, or inhibitors of serotonin re-uptake.
Chronic depression is prevalent throughout the world, and is a cause of great concern, as any neglect in controlling this condition could lead to the individual developing suicidal tendencies.
Paroxetine is a classic example of an SSRI (Selective serotonin re-uptake inhibitor) and is manufactured by Apotex. Receiving the ANDA (Abbreviated New Drug Application) approval from the governing authorities is a big step for Jubilant.
To date, Jubilant has an impressive record of filing 820 formulations, of which 391 have been cleared by the regulatory authorities worldwide. This number is inclusive of the 71 ANDAs that have been filed in the US, with the bestowal of USFDA clearance for 39 of these applications.
Paroxetine, will soon be manufactured, marketed and distributed by Jubilant Life Sciences, with initial sales in India.
Dr. Jay Shinde