Wanbury Ltd Receives ANVISA Approval for Sertraline Form II
Filing Summary
Wanbury Ltd announced the receipt of approval from ANVISA, Brazil, for Sertraline Form II. This approval is in addition to the existing approval for Sertraline hydrochloride Form I. Wanbury holds a 75% market share for Sertraline in Brazil. Additionally, the company received approval from a major customer for a special grade of Metformin DC, with an estimated business opportunity of INR 15 crore annually. Both API manufacturing sites, Patalganga and Tanuku, comply with cGMP regulations.
On 12th March 2026, Wanbury Ltd announced that it received approval from ANVISA, Brazil, for Sertraline Form II. This approval is in addition to the existing approval for Sertraline hydrochloride Form I. Wanbury currently holds a 75% market share for Sertraline in Brazil.
The company also received approval from one of its largest customers for a special grade of Metformin DC. The potential business opportunity from this approval is estimated at approximately INR 15 crore per annum. Wanbury’s API manufacturing sites at Patalganga and Tanuku continue to comply with cGMP Rules and Regulations.
Wanbury Ltd focuses on the pharmaceutical sector, specializing in the production and distribution of active pharmaceutical ingredients (APIs) and formulations. The company is committed to expanding its market presence and maintaining compliance with international regulatory standards.