New DMF shared in South Africa for Tramadol HCl API; DMFs also shared in Philippines and Singapore

Wanbury shared a new Drug Master File (DMF) in South Africa for Tramadol HCl API, and DMFs in Philippines and Singapore for Metformin HCl API.

Thu 8 Oct 2026

New DMF Shared

New Drug Master File (DMF) in South Africa for Tramadol HCl API

DMF Updates

DMFs in Philippines and Singapore for Metformin HCl API

Approvals Received

EDQM approval for CEP shared API Paroxetine HCl; TGA accepted the compliance report for the Australia market

Wanbury Limited has informed the exchanges about a set of regulatory updates and approvals for its active pharmaceutical ingredient (API) business. The update covers several products and several markets.

South Africa — Tramadol HCl

• The company shared a new Drug Master File (DMF) in South Africa for Tramadol HCl API.
• A DMF is a document a manufacturer files with a country's drug regulator. It carries the confidential details of how an API is made, tested and controlled, and the regulator refers to it when a customer's finished medicine is being approved.
• Update a DMF is an early step in opening that market for the company's API, since customers there can then reference it.

Philippines and Singapore — Metformin HCl

• The company also shared DMFs in Philippines and Singapore for Metformin HCl API, to meet customer expectations.
• Metformin is a widely used diabetes medicine, so these updates relate to supplying customers in these two markets.

Paroxetine HCl — supply chain

• The company added additional Key Starting Materials (KSM) vendors to ensure supply chain continuity for its CEP shared API, Paroxetine HCl, and received approval from the office of the European Directorate for the Quality of Medicines and Healthcare (EDQM).
• A CEP is a certificate of suitability issued in Europe. Adding KSM vendors is about having more than one source of raw input, which supports continuous supply of the API.

Australia — inspection status

• Therapeutic Goods Administration (TGA) accepted the compliance report for the inspectional observations, which will enable the company to continue supply of its APIs for the Australia market.

What this kind of update means

• DMF updates are regulatory groundwork. They allow the company's APIs to be considered by customers and regulators in those markets.
• Adding KSM vendors and receiving the EDQM approval relate to keeping supply uninterrupted for an existing CEP shared product.
• How much business these steps translate into depends on customer orders and on the updates being taken up in each market.

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