Opening Hours: Mon - Sat 8.00 - 18.00

Regulatory & Compliance Documents

EMEDICS PHARMACEUTICALS LIMITED maintains comprehensive documentation in accordance with internationally recognized pharmaceutical standards and regulatory requirements.

Certificate of Incorporation

Certificate No. 138065650 issued under the Companies Act, 2002 of the United Republic of Tanzania. Incorporated on 2 November 2018 as EMEDICS PHARMACEUTICALS LIMITED, a private limited company authorized to undertake pharmaceutical manufacturing and related business activities.

Memorandum & Articles of Association

The Company's constitutional documents governing its operations, shareholder rights, director responsibilities, and corporate governance framework in compliance with Tanzanian corporate law.

Tax Registration Certificate

Registered taxpayer with the Tanzania Revenue Authority (TRA) for corporate income tax, VAT, and other applicable statutory obligations.

Site Master File (SMF)

Comprehensive document describing the pharmaceutical manufacturing facility, quality management system, production processes, and quality control procedures in accordance with WHO-GMP guidelines.

Quality Management System

Standard Operating Procedures (SOPs), validation protocols, quality assurance manuals, and quality control documentation aligned with WHO-GMP and TMDA requirements.

Environmental Compliance

Environmental Impact Assessment (EIA) and regulatory submissions to the National Environment Management Council (NEMC) demonstrating commitment to sustainable pharmaceutical manufacturing.

Project & Manufacturing Documents

Factory Design & Layout

Architectural and engineering plans for the 3,625 m² pharmaceutical manufacturing facility in Kerege, Bagamoyo.

Equipment Qualification

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for all manufacturing and laboratory equipment.

Product Dossiers

Comprehensive product documentation including formulation, manufacturing process, specifications, stability data, and labelling.

For document requests or regulatory inquiries, please contact us at info@emedics.co.tz

A Tanzanian pharmaceutical manufacturer dedicated to strengthening Africa's health through quality pharmaceutical manufacturing, innovation, and regulatory excellence.

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Kerege, Bagamoyo District, Pwani Region, Tanzania
Incorporated: 2 November 2018

Standards

WHO-GMP Compliant

TMDA Regulated

EAC | SADC | AfCFTA