Dosage Forms

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

PCI will be participating in two Speakers Corner slots at the ICSE Exhibitor Showcase.

West will showcase several drug-delivery systems and packaging component technologies such as its NovaPure plungers and SmartDose technology platform.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

Flexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.

A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

The merger of Avantor Performance Materials and Nusil Technology positions the company for growth in bioprocessing.

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.