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Responsible sourcing and manufacturing: Growing towards a sustainable future with Lonza

Express Pharma

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. In March 2024, Lonza hosted its first digital Responsible Supplier Event which brought together more than 1,100 participants.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

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Survey: Impacts of Tariffs & Trade Policy on the Bio/pharmaceutical Industry

PharmaTech

The industry's dependence on geopolitical stability and predictable trade relationships is increasingly critical for global pharmaceutical manufacturing. Tariffs disrupt supply chains, impacting both finished products and raw materials, complicating compliance and cost forecasting. Share your voice!

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What Pharma Manufacturers Need to Know About US Trade Policy Changes

PharmaTech

In this first segment of a multi-part interview, Jason Waite, international trade expert at Alston & Bird, outlines how recent United States tariff activity could significantly impact pharmaceutical manufacturers.

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CDMO acquires Meppel facility from Astellas

European Pharmaceutical Review

Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The company employs more than 6,500 people, generating revenues of €1.1

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

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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Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle

Quality Matters

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.