Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Cook Pharmica Gains Commercial Manufacturing Approval | Contract Pharma

What are you searching for?

Sign in
Breaking News

Cook Pharmica Gains Commercial Manufacturing Approval

FDA inspection covers new filling line lyophilization capabilities, and quality systems

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Cook Pharmica has received approval from the FDA for the manufacture of commercial product. The approval follows an inspection by the FDA’s Center for Biologics Evaluation and Research covering the company’s new filling line, lyophilization capabilities, and quality systems.

“This FDA decision marks a very important milestone for our company,” said Tedd Green, president of Cook Pharmica. “This first commercial manufacturing approval opens Cook Pharmica’s doors to access the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the U.S. and worldwide.”

The company’s parenteral manufacturing business unit contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to ready products for distribution. The company is capable of filling 15 million vials and 70 million prefilled syringes annually.
 

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics