Outsourcing

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

PCI is extending its cryogenic storage capabilities to its Rockford, Illinois operations to support storage and distribution of clinical trial materials.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

The new facility will focus on formulation development, drug product analytical development, and quality control.

CMO executives are focusing on M&A activity, new business models, and fundraising limits.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

This key bioprocessing segment is expecting continued growth

The company announced that an August 2016 FDA inspection of the company’s facility resulted in no form 483s.

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

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

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

The new facility is solely dedicated to offer extractables and leachables (E&L) testing services to the pharmaceutical and related industries.

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.

API and drug product manufacturer changes name to align with parent company.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

The agreement comprises technology transfer and commercial manufacturing of Tillotts’ gastroenterology products.