Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

The Potential of Perfusion

Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients

Agnes Shanley is senior editor of Pharmaceutical Technology.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Handling HPAPIs: Do Your CMOs Have the Right Stuff?

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

Needle in the Haystack, or Rembrandt in the Attic? Drug Repurposing's New Strategy

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Indian API Manufacturer Cited for Recordkeeping Failures

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

SafeBridge Updates Potent API and Drug Manufacturer Status

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

DPx Holdings Sells Fine Chemicals Business

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

EMA Releases API Bioequivalence Studies Guidance

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

AMRI Acquires Gadea Pharmaceutical Group

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Ingredients