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The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed. 

FDA Improves Transparency and Predictability for Generic Drug Applicants

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.


European Private Equity Group Acquires UK Pharma Generics Firm

A CPhI Middle East & Africa (MEA) expert has forecasted a boom in manufacturing in the region and has expectations that within five years some of the industry will be acting as contract manufacturers for the European market.

Middle East Manufacturing Market Set for Growth, Notes CPhI

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

FDA Publishes Guidance on Interchangeability of Protein Products

Cambrex’s expanded quality control laboratory supports generic API development.

QC Lab Extends Capabilities at Cambrex’s Milan Facility

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

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Select Suppliers with Demonstrated Expertise to Avoid Sourcing “Bad” APIs

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls. 

FDA Approves New Generic Valsartan

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

Latest ARB Recall Triggered by New Impurity

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

FDA Reacts to Generic Drug Critics

The guidance explains the process of applying for competitive generic therapy designation.

Generic Drugs