API Archives - Medical Design Sourcing

Pharma supply chain facing a perfect storm

Image courtesy of Felix Mittermeier on Pixabay

The tensions facing the global supply chain have been building in the pharmaceutical industry since even before the pandemic began, said Apurva Saraf, CEO of privately-held Cosette Pharmaceuticals (South Plainfield, New Jersey), in a recent interview.

About five years ago, China, a central producer of active pharmaceutical ingredients (APIs), began shutting down tens of thousands of factories as a result of environmental infractions.

After the SARS-CoV-2 virus emerged in Wuhan, additional factory closures constricted production further.

There was a “rolling effect” when the pandemic began in China and later spread to Italy and New York and New Jersey in the U.S. — all critical areas for the pharmaceutical industry, Saraf said.

Repeated stringent lockdown measures in countries such as China, Italy and India reduced the flow of dru…

Addressing vulnerabilities in the medical product supply chain

Image courtesy of Pexels

While the medical product supply chain has always been subject to vulnerabilities, those weaknesses were laid bare early in the COVID-19 pandemic. Drug and medical device supply chains have historically been susceptible to factors such as a lack of supplier redundancy, components, active pharmaceutical ingredient (API) or finished product manufacturers. But pandemic-driven sourcing and workplace disruptions magnified these pain points, resulting in the ongoing problems that have persisted for the past two years.

Although the root causes are complex and the possible solutions numerous, important developments at the U.S. Food and Drug Administration (FDA) have led to increased transparency about drug and medical device shortages. Although this transparency is a promising starting point for formulating short- and long-term supply chain solutions, strong policy development, planning and …

Everest Organics begins manufacturing API for molnupiravir

Molnupiravir photo courtesy of Merck.

Bengaluru, India–based Everest Organics (BOM:524790) saw its share price jump 15% today to ₹347.10 after announcing it has begun manufacturing the active pharmaceutical ingredient (API) for a molnupiravir generic.

Molnupiravir is an experimental oral drug that appears to substantially reduce the rate of COVID-19-related hospitalization for patients with mild-to-moderate infections.

Reuters has reported that molnupiravir developer Merck (NYSE:MRK) has agreements with multiple Indian companies related to the manufacture of the drug.

Merck partnered with Ridgeback Biotherapeutics in developing molnupiravir, which scientists with ties to Emory University initially discovered.

“After the successful development and commercialization of various COVID-19 drugs, such as Oseltamivir, Remdesivir, [and] Posaconazole, Everest Organics Limited is on its path of …