Regulatory

Regulatory approach

No portfolio line is registered anywhere. This page describes the regulatory requirements each line must satisfy before supply.

Lao FDD registrationGMP batch recordsTrilingual labelling

Where the company stands today

Luang Pharma is establishing a pharmaceutical manufacturing facility in the Boten Economic Zone, Lao PDR. The company is not yet manufacturing, holds no manufacturing licence, and none of its portfolio lines are registered or available for supply.

Before any product is supplied

Each portfolio line requires Lao FDD registration, GMP batch records, a validated analytical method, a stability programme, QA release and approved trilingual labelling. Those requirements are stated on every product record in the portfolio, and none of them is satisfied yet.

Country-by-country registration

Registration is country-by-country and product-by-product. The plan begins with the Lao market, which requires the manufacturing licence and product testing. Export follows only after manufacturing licensing, quality system implementation and registration in each target market.

Requesting documentation

Regulatory and documentation enquiries are answered at info@luangpharma.com. Please state the country, the portfolio references you are interested in and the documents you need.

Contact

Write to info@luangpharma.com.