Newsletter | May 16, 2023

05.16.23 -- Developing Robust Supply Chain Strategies

Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply

Throughout the pandemic, painkiller and sedative demands spiked, and demand for bupivacaine HCl, a powerful analgesic and anesthetic medicine, dramatically increased. As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of bupivacaine HCl and other essential drugs.

Investing In Capacity: API Commercial Manufacturing

A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise, cGMP assets, and exemplary quality systems and U.S. FDA track records. Learn how a partner with the right scale-up and commercial production expertise was able to find a cost-effective process to produce the API for a new drug.

Digital Transformation In Regulatory: Achieving Excellence Virtually

The COVID-19 pandemic demanded significant pivots, and technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to GMPs. Key decision makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

Balancing Cost Efficiencies In The Drug Development Process

Companies looking to increase cost efficiencies have various considerations to incorporate. Decision-making around effective project management, partnerships strategy, and developing sustainable processes requires crucial consideration throughout drug development. Learn how outsourcing helps to achieve success in these areas, which combine to increase cost efficiency.

Controlled Substances Manufacturing

Storing, handling, and distributing scheduled materials requires special consideration, and partnering with an experienced manufacturer is crucial for navigating strict regulatory pathways. Cambrex holds U.S. Drug Enforcement Agency (DEA) licenses for process research, development, manufacturing, and importation of Schedule I to IV controlled substances.

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