Sun Pharmaceutical Industries entered into a licensing agreement with Ferring Pharmaceuticals to commercialise innovative obstetric drug Caritec in India.
One of the company’s wholly-owned subsidiaries has entered into a license agreement with Ferring Pharmaceuticals Pvt Ltd — a subsidiary of Switzerland-based Ferring Pharmaceuticals — to commercialise a room temperature stable formulation of the obstetric drug Caritec in India, Sun Pharma said in a regulatory filing.
The drug is indicated for the prevention of excessive bleeding in women after vaginal or caesarean childbirth.
As per the agreement, Sun Pharma is granted rights for co-marketing of the drug in India in the private market under the brand name Caritec.
Ferring has developed the drug and received approval from the Drugs Controller General of India (DCGI) for introducing the medicine in India, Sun Pharma said.
Caritec is the oxytocin analogue that is used to prevent haemorrhage following caesarean section.
Caritec is the brand of Carbetocin RTS.
Currently, WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. Oxytocin, however, must be stored and transported at 2–8 degrees Celsius, which is hard to do, in many low-income countries, depriving many women the access to this lifesaving drug. CARITEC® is a drug similar to oxytocin with longer duration of action. The new Room temperature stable formulation of carbetocin does not require refrigeration and retains its efficacy for 2 years stored at 30 degrees Celsius and 75% relative humidity.
A study published in the New England Journal of Medicine with 30,000 patients has shown room temperature stable carbetocin to be as safe and effective as oxytocin in preventing postpartum haemorrhage. The study included almost 7,000 women from India. This new room temperature stable formulation of carbetocin, to prevent excessive bleeding following childbirth, could save thousands of women’s lives.
PABAL® / DURATOCIN® / LONACTENE® / DURATOBAL® (carbetocin)
PABAL / DURATOCIN / LONACTENE / DURATOBAL (carbetocin) is Ferring’s brands for Carbetocin.