Pharma Capsules

Agreements

Hunt to Build Plant for Gaylord

Gaylord Chemical (Slidell, LA) and Hunt Refining (Tuscaloosa, AL) signed a long-term exclusive manufacturing and licensing agreement. Hunt Refining will build and operate a 50,000,000-lb dimethyl sulfide (DMS) plant at its Tuscaloosa site using Gaylord's DMS production technology. The plant will supply DMS exclusively to Gaylord, thus providing them with the largest DMS capacity in the world, according to the companies. Construction is expected to be completed in mid-2010.

In addition, Gaylord Chemical will be expanding and relocating its dimethyl sulfoxide production to a site adjacent to the DMS production facility in Tuscaloosa. This relocation will occur in late 2010.

Regulation

FDA Approves Vetter Production

The US Food and Drug Administration granted Vetter Pharma-Fertigung (Ravensburg, Germany) approval for the production of a new client drug. Vetter, which provides contract manufacturing services for pharmaceutical and biotechnology companies, will begin filling the new drug at its Ravensburg Vetter South facility. The company says the latest FDA client product approval demonstrates its competence in producing aseptically prefilled injection systems for the production of biotechnological and complex medications.

US Pharmacopeia Inaugurates New Headquarters

The US Pharmacopeia (USP, Rockville, MD) held an official grand-opening celebration for its new global headquarters in Rockville. The new site boasts a 141,000-ft² office building that houses three laboratories. A separate 16,000-ft² meeting center contains a 273-seat auditorium, five meeting rooms, and a training center.

"USP's new state-of-the-art headquarters facilities allow us to stay at the forefront of science, with new and advanced laboratory operations," said Roger L. Williams, USP's executive vice-president and CEO. "The new meeting center will help us continue to bring together the top scientific and medical experts from around the world to set the highest quality standards for pharmaceuticals and food ingredients."

Expansions

Xcelience Adds to Its Capabilities

Xcelience (Tampa, FL) became the first contract research organization in North America to purchase Capsugel's "Xcelodose 600 S" precision powder microdoser and automated encapsulator.

The unit fills at speeds higher than 600 capsules/h at 50% greater throughput than its predecessor, the "Xcelodose 600." The new machine is expected to debut at Xcelience as early as May 2008.

Xcelience has grown since its inception and continues to expand its capacity. "Adding to Xcelience's arsenal of tools for assisting our clients to accelerate their early drug development pipelines is paramount to our strategic philosophy," says Randall Guthrie, Xcelience's vice-president.

Ross Opens Indian Factory

Charles Ross and Son (Hauppauge, NY) opened a new manufacturing plant in Pune, India. The plant is a 100%-owned facility located 150 km from Mumbai. Ross's Regional Manager Lokendra Singh oversees the operation of this new plant.

Ross's facility in Pune, India.

Ross initially will manufacture dry-solids blenders and high-shear mixers at the site. The company expects to expand the facility and add new product lines within the next 12 months. Products manufactured at the facility are initially being marketed in India, Southern Asia, Central Asia, and the Middle East but are available to worldwide markets.

PII Opens Development and Aseptic Facility

Pharmaceutics International (PII, Hunt Valley, MD) opened a new 30,000-ft² , state-of-the-art development, aseptic filling, and manufacturing facility. The new Beaver Court complex complements the three existing PII facilities in Hunt Valley and those of Pharmaterials (Reading, UK).

PII's development work has moved to dedicated manufacturing space in the new building. The area consists of multiple manufacturing and containment suites to perform development projects. This area will support projects before they enter production.

The aseptic facility provides vial filling for clinical supplies and niche commercial manufacturing. The filling line will initially fill small molecules and is designed to fill containment and high-potency products. A 60-ft² lyophilizer was installed and qualified to produce lyophilized products.

People

Bilcare NamesNew CEO

Bilcare Global Clinical Supplies (Pune, India), a provider of clinical-trial materials, appointed Vito Mangiardi, a 30-year industry veteran, as its new CEO. Mangiardi most recently served as president of North American Operations for AAI Pharma (Wilmington, NC), where he was responsible for Phase I services, formulation development, analytical development, bioanalytical, manufacturing, and stability testing, as well as Phase II–IV clinical trials.