Articles

Say an export, regulatory, or logistics lead sends out a batch of drugs, includes the Drug Master File (DMF) number with a shipment, and expects the DMF to “clear” the shipment. Days later[...]

The Solomon Islands have a high burden of malaria and neglected tropical diseases. It has a fast-rising burden of noncommunicable diseases and lacks local drug manufacturing. Despite these issues, it[...]

If you are responsible for sourcing, regulatory affairs, or business development for a pharmaceutical manufacturer, the next 5 years will reward the former and punish the latter for good reason. Afric[...]

When it comes to Global API manufacturing costs between 2020 and 2024, there are significant changes. Natural gas prices doubled. The Solvent prices have increased manifold. Also, Key starting materia[...]

Pharmaceutical manufacturing has run on batch production for over a century: react, isolate, dry, test, release, repeat. It works. But it is slow, wasteful, variable, and increasingly misaligned with[...]

In November 2025, the WHO Regional Director for the Western Pacific, himself a Tongan physician, published a rare personal account of an antibiotic access failure in Tonga. He described a child brough[...]

As we learned better how to offer APIs with formulated goods to the Pacific Island markets, we faced a challenge for which we couldn’t find a solution in the regulatory textbooks available to us[...]

A Complete Guide for Indian API Exporters and Pacific Pharma Buyers Vanuatu sits at a unique regulatory intersection in 2025-2026. It has no functioning National Regulatory Authority (NRA) to formally[...]

A formulation company makes a large order from a supplier that has a WHO-GMP certificate. The batch order passes in-house QC. Then a regulatory audit triggers a series of problems. The supplier had di[...]

Papua New Guinea (PNG) is an Island country situated in the Oceania region. With a population of approximately 11.8 million, this Island comprises 18 provinces with a total area of 462,840 km². T[...]