Regulatory Disclosure
This press release is submitted pursuant to Regulation 30 of SEBI LODR (Listing Obligations and Disclosure Requirements).
Business Expansion and Regulatory Filings
Wanbury Limited has undertaken several strategic initiatives to expand its business opportunities and ensure regulatory compliance across international markets:
- New Drug Master File (DMF) Filing - South Africa: The company filed a new DMF in South Africa for Tramadol HCl API (Active Pharmaceutical Ingredient).
- Additional DMF Filings - Asia Pacific: The company filed DMFs in Philippines and Singapore for Metformin HCl API to meet customer expectations.
Supply Chain and Quality Assurance
Wanbury has implemented measures to strengthen its supply chain and maintain quality certifications:
- Supply Chain Continuity: Added additional Key Starting Materials (KSM) vendors to ensure supply chain continuity for its CEP (Certificate of Suitability) filed API, Paroxetine HCl.
- European Regulatory Approval: Received approval from the office of European Directorate for the Quality of Medicines and Healthcare (EDQM) for Paroxetine HCl.
- Australian Market Compliance: Therapeutic Goods Administration (TGA) accepted the compliance report for inspectional observations, enabling the company to continue supply of its APIs to the Australian market.
Management and Signatory
This disclosure was signed by Jitendra J. Gandhi, Company Secretary of Wanbury Limited, in accordance with regulatory requirements.