J.B. Chem receives DCGI approval for Rantac CD tablets
J.B. Chemicals & Pharmaceuticals Ltd has received approval from the Drugs Controllers General of India (DCGI) to market its Rantac CD (ranitidine) formulations in India, making it the first Indian company to receive this permission. Rantac CD is indicated for the treatment of Gastro Esophageal Reflux Disorder (GERD) and will be marketed in 150mg. and 300mg. dosage forms.
Rantac is JBCPL's second largest brand and its Sales for in FY 2002-03 amounted to approx. Rs. 23 cr., i.e. 9% of the Company's total turnover of Rs. 291.77 cr. The Company is also in the process of filing the necessary application under para 25 of Drugs Price Control Order 1995, claiming exemption from price control. The current market size of Ranitidine-based formulations in India is approx. Rs. 150 cr.
Manufactured at the Company's Panoli plant located in Gujarat, J.B. Chem currently holds patents for Ranitidine in the USA, South Africa and India.
The special technology developed by the Company's in-house R&D team is a unique achievement for a high volume product sold worldwide in an important therapeutic group, the anti-peptic ulcerant category.