Articles

The samples looked good. The price was right. The contract is ready to be signed. But one critical question remains unanswered: would this supplier pass a regulatory inspection?, How to Qualify an API[...]

You will only have 2 or 3 days on-site. Those months your supplier had in preparation were spent developing their SOPs and answering questions, timing facility tours to the minute. What you decide in[...]

On Tuesday mornings, one might expect to see new invitations for tenders in their inboxes. Some respond because the product matches the tender specifications, the price is competitive, and the potenti[...]

There are very real challenges related to your savings targets, and you’re right to feel the weight of them. Prices for finished goods are dropping; boards are instructing procurement to improve[...]

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 shipme[...]

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[...]