China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) announced that it has received market clearance from the National Medical Products Administration (NMPA) for its generic version of Sanofi’s No-Spa (drotaverine). This marks the first generic version of No-Spa to be approved in China.

Approved Indications
The product is now permitted for use in treating smooth muscle spasms associated with biliary diseases, such as gallbladder or bile duct stones and cholecystitis or cholangitis. It is also approved for smooth muscle spasms caused by urinary system diseases, including kidney or ureteral stones and pyelitis or cystitis.

Market Entry
No-Spa was first approved for marketing in China in June 2000. Lianhuan Pharma’s generic version is the first of its kind in China and has successfully passed the generic quality consistency evaluation.-Fineline Info & Tech