Blog Dosage Pharmaceutical Manufacturing 
Express Pharma
JANUARY 17, 2025
As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. The path forward requires continued innovation, partnership, and dedication to environmental stewardship.
FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
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Express Pharma
APRIL 13, 2023
They are less toxic and have a higher degree of solubility, thus making them better candidates for liposomal-based drug delivery systems, especially for parenteral administration and inhalation dosage forms. Quality assurance and costs remain a major challenge.
Quality Matters
SEPTEMBER 15, 2023
PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., See related Quality Matters blog on regulatory considerations.
Quality Matters
FEBRUARY 19, 2025
India and the United States manufacture most finished medicines for the U.S. market This blog is part of a series on the geographic concentration of pharmaceutical manufacturing. This blog focuses on the manufacturing of finished dose forms. For a discussion on API manufacturing, see here.
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