J B Chemicals & Pharmaceuticals Ltd (JBCPL), a Rs. 740 crore plus Mumbai based pharma major, has received US FDA approval for diclofenac sodium (non-steroidal anti-inflammatory drug) tablets for 25 mg and 50 mg. It already markets 75 mg delayed release tablets of diclofenac sodium in US markets. With this new approval, JBCPL now has full range of diclofenac sodium formulations to offer in US market. This new approval will help to increase the existing business of 75mg tablets.
It has established partners in US for this product it is expecting to commercialize this approval in Q4 of this year. The estimated market in US for diclofenac sodium formulations is US$ 400 million.
J B Chemical manufactures the API diclofenac sodium itself that will help achieve better margins. With this approval, it is poised to become significant generic player in the business of this product in US market.