WHO-GMP Manufacturing Standards: Inside the Gazipur Facility Partnership with Amulet Pharmaceuticals

A Manufacturing Foundation Built on Quality Assurance

Sanveex Global Health partners exclusively with Amulet Pharmaceuticals Ltd., an advanced pharmaceutical manufacturer operating a state-of-the-art facility located in Singdighi, Mawna, Sreepur, Gazipur, Bangladesh. The facility operates in strict compliance with the World Health Organization's Good Manufacturing Practice (WHO-GMP) code and active Drug Manufacturing Licences No. 418 & 287 issued by the Directorate General of Drug Administration (DGDA).

Class C and D Cleanroom Architecture

Formulation purity begins with environmental engineering. The Gazipur plant utilizes precision air-handling units (AHUs) with multi-stage HEPA filtration capable of removing 99.97% of airborne particulates down to 0.3 microns. Cleanroom suites maintain:

• Differential Positive Pressure Cascades: Ensuring air always flows outward from critical processing areas to prevent cross-contamination.
• Constant Environmental Validation: Continuous laser particle monitoring, temperature control (20°C ± 2°C), and relative humidity stabilization (below 45% for hygroscopic solid dosages).
• Laminar Air Flow (LAF) Stations: Dedicated sterile booths for raw material sampling and active pharmaceutical ingredient (API) dispensing.

Automated High-Speed Packaging & 100% Optical Inspection

Solid oral dosages including Montilet 10, Adcal D, and Xofedin 120 are packaged on high-speed thermoforming and cold-form Alu-Alu blister lines. Automated high-resolution optical inspection cameras scrutinize every single pocket for tablet completeness, color consistency, and surface defects before carton sealing.

Retained reference samples and comprehensive batch production records (BPRs) are archived for every manufactured lot, ensuring total auditability throughout the product shelf life.