Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.

Combination Drugs: Adding Up the Opportunities

Watson Laboratories has recalled two lots of hydrocodone bitartrate and acetaminophen tablets.

Watson Issues Voluntary Recall of Combination Drug

FDA Sets Limits for Acetaminophen in Prescription Combination Products

Regulatory Roundup: FDA Sets Limits for Acetaminophen in Prescription Combination Products

Abuse-deterrent combination drugs represent a niche area in formulation development.

Formulation Development Forum: Abuse-deterrent combination drugs

Angie Drakulich was editorial director of Pharmaceutical Technology.

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.

FDA Issues Proposed Rule on CGMPs for Combination Drug Products

Malcolm Ross is President at Generapharm  Training and Consultancy, Basel (Switzerland).

Combination products have been researched and administered for many years, some successfully and others not.

The combination drugs debate: unstable and unpatentable

Suryakumar Jayanthi is Senior Director at Dr Reddy's Laboratories Ltd (India).

Avvaru Seshasayana is a formulation group leader at Dr Reddy's Laboratories Ltd (India).

Satti Phanikumar Reddy is an analytical group leader at Dr Reddy's Laboratories Ltd (India).

Rajesh Dubey is Project Manager at Dr Reddy's Laboratories Ltd (India).

Combining drugs with synergistic mechanisms of action yields some indisputable benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few.

The combination drugs debate: Incompatibility problems can be overcome

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

Draft Guidance Issued for Injectors Development

The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company's "Bayer Women?s Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" over-the-counter (OTC) products.

Manufacturing, Combination Drugs