Manufacturing

Best practices for buying, selling, and transporting second-user equipment.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The Gx RTF ClearJect syringe is made of cyclic olefin copolymer and is tungsten- and adhesive-free.

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

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.

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

CMOs experiment with new filtration and purification methods to alleviate downstream bottlenecks and stay competitive.

In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.

Renovating a facility requires careful design and a plan to minimize production interruption.

Industry experts discuss recent trends in modular manufacturing.

A process-specific preventative maintenance program improves productivity and reliability.

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.

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

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.

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

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

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

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

One of the major challenges in working with excipients today is understanding, and adjusting to, complexity in materials and formulations.

Innovative technologies and services meet needs for existing and emerging biologic-based therapies.

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

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.