JHP Pharmaceuticals, a provider of global contract manufacturing services for sterile injectable products announced today that it has entered into an agreement with an undisclosed pharmaceutical company for the product transfer and registration batch production of a diagnostic aid.

Baltimore, MD, September, 22, 2011 – UPM Pharmaceuticals announced today that they will expand their existing manufacturing capacity, including an OEB 4 processing room, a low humidity processing suite, and a unique dedicated Xcelodose production facility.

Catalent to become #2 global clinical trial supply solutions provider, Aptuit to focus on discovery-to-mid phase development business.

The Black Pearl Viscometer from ATS RheoSystems is a high performance rotational viscometer capable of both steady shear and yield stress testing in a rugged, compact size footprint.

JHP Pharmaceuticals, a leading provider of contract manufacturing services for sterile injectable products has entered into an agreement with an undisclosed biotech company to produce clinical trial batches of an innovative drug used in the treatment of heart failure.

Thursday, 14 July 2011 12:17

Vetter Wins Frost & Sullivan Award

Leading contract development and manufacturing organization (CDMO) Vetter has received the Frost & Sullivan 2011 European Prefilled Injection Systems Customer Service Leadership Award. The international consulting company recognized Vetter for best practices in its collaboration with global customers, in particular, the added value due to the outstanding quality of service the company creates for its partners. Vetter plays a significant role in the success of its clients by providing crucial support from early development of drugs through regulatory approval and market supply worldwide. The award ceremony is to be held on September 29 in London (Great Britain).

Prior to granting the award, Frost & Sullivan examined service providers from the global pharmaceutical and biotech industries focusing on four criteria: quality, timeliness, customer benefits and cost of services. These criteria were analyzed both qualitatively and quantitatively, taking into account the current situation and trends in the market. Following this extensive analysis, Vetter was selected as the 2011 European Prefilled Injection Systems Customer Service Leadership Award recipient.

In explaining its decision, Frost & Sullivan’s Program Manager, Ranjith Gopinathan said, “Vetter is renowned for its quality, innovation and loyalty as a strategic partner for pharmaceutical and biotech clients. As a leading CDMO, Vetter offers its customers “service throughout all stages of a drug’s development and through all the lifecycles, providing the necessary support at all times.” Vetter is specialized in working with complex substances and has extensive experience with a broad array of compounds, including monoclonal antibodies, peptides, interferons and vaccines. He further explained, “this will provide the pharmaceutical company with valuable time and resources to concentrate on core activities, namely research and development into other drugs and marketing.”

Vetter managing director Peter Soelkner was thrilled with the news. “This recognition by Frost & Sullivan, one of the most prestigious international consulting firms is an impressive achievement,” he said. “However, we do not view the award as an end in itself. Rather, it is a justification of our business model of resolute customer orientation and a challenge to exceed even our high business standards. We will continue to make every effort to provide our customers with the best possible support available, helping them to secure their success in the global marketplace.”

About Vetter:

Vetter is an independent international specialist in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of substances, including monoclonal antibodies, peptides, interferons and vaccines. Headquartered in Ravensburg, Germany, Vetter provides support for pharmaceutical and biotech clients from preclinical development through regulatory approval and global market supply. Vetter’s new Chicago facility, an expansion of Vetter Development Service, supports  earlystage products. The firm works with the world’s leading pharmaceutical and biotech companies, and employs approx. 2,400 staff across Europe and the United States. The innovator of the Vetter Lyo-Ject® dual-chamber syringe and V-LK® cartridge, the company holds nearly 140 patents and is a leader in the use of RABS technology in cleanrooms. Approved as a foreign manufacturer by the government of Japan, Vetter’s global regulatory experience includes numerous customer product approvals by the FDA, EMA and other authorities. Over its more than 25-year history in aseptic filling, Vetter has won many awards for its facilities and operations, including the 2010 SAP EMEA Quality Award, silver medal, for the implementation of a companywide planning software system.
Norwich, a provider of full-service contract development and manufacturing for the pharmaceutical and biotech industry, today announced the addition of three business development leaders. Mitchell Winfree has been appointed Vice President, Business Development, while Gregory Downs and Bob Peoples both have joined the company in the role of Director, Business Development.

Mitchell Winfree joins Norwich Clinical Services to develop and lead the regional expansion for the CRO business in North America. Winfree brings a track record for leading successful business development operations for both large, global CROs as well as smaller, therapeutically focused providers. He possesses nearly 20 years’ experience in discovery, pre-clinical, and clinical research that has been demonstrated through career achievements with PPD, Rho, and Clinsys Clinical Research. Winfree earned a B.S. degree in Biology with a minor in Genetics from North Carolina State University.

Gregory Downs joins Norwich with more than 15 years of pharmaceuticals, clinical testing and development sales experience, with additional expertise in clinical pharmacy and analytical testing. He is responsible for expanding Norwich operations in the northeast United States and eastern Canada. Downs began his career in clinical pharmacy and analytical testing and he has since held leadership positions in business development with Azopharma, Biovail and Aurobindo Pharma. Downs holds a B.S. degree in Biology with a minor in Chemistry from Campbell University.

Bob Peoples has more than 25 years’ experience in pharmaceutical manufacturing, sales and marketing, and he will be responsible for growing Norwich business in the southeast United States. He has directed manufacturing and packaging operations at Burroughs Welcome and DSM Pharmaceuticals and has spent the last 10 years in sales and customer service. Peoples earned a B.S. in Business Administration from East Carolina University.

“We’re extremely pleased to welcome Mitchell, Greg and Bob to Norwich,” said Terry Novak, president of Norwich Pharmaceuticals. “Their leadership will be instrumental as Norwich further expands our capability to provide customers with one comprehensive solution for all stages of the product lifecycle.”

About Norwich
Norwich is a full-service contract development and manufacturing provider for Rx and OTC pharmaceuticals. Norwich applies more than 120 years of experience and an unparalleled compliance record to offer customers greater flexibility, resources and speed that result in a streamlined progression from product development to scale-up and commercial manufacturing through clinical services. Visit www.norwichpharma.com for additional information.
JHP Pharmaceuticals (“JHP”) announced today that Stuart Hinchen would succeed Peter Jenkins as Chief Executive Officer of the company effective July 1, 2011. Stuart Hinchen has acted as JHP’s President and Chief Operating Officer since the formation of the company in 2007.

Peter Jenkins commented: “Over the past four years we have established JHP on a secure financial and operational basis with growing revenues and strong profitability as well as put in place an assured platform for growth in both our marketed products and contract manufacturing business. In particular, over the past twelve months, we have established a rapidly growing pipeline of generic injectable products using both out-sourced development resources and an internal development group based at our Michigan manufacturing facility. The secure position the business is in provides me with the opportunity to step back from day to day activities knowing that the full time leadership of the business is in excellent hands. I will remain fully invested and also involved as a consultant with the business through supporting Stuart with the development activities.”

Stuart Hinchen commented: “JHP has a wonderful opportunity over the coming years to actively redefine the generic injectable competitive landscape in the USA. Peter remains a valued architect of our business development efforts and how we progress the company through future growth.”

About JHP Pharmaceuticals, LLC

JHP, headquartered in New Jersey, is a specialty pharmaceutical company which develops, manufactures and sells pharmaceutical products, primarily aseptic injectable products into the hospital segment, and provides contract manufacturing of sterile products for pharmaceutical companies. JHP is a private company wholly owned by JHP Holdings, LLC whose equity owners are Morgan Stanley Principal Investments, Peter Jenkins and Stuart Hinchen.

For more information, please visit www.jhppharma.com.
OSO BioPharmaceuticals Manufacturing, LLC, has been granted research and analytical licenses by the U.S. Drug Enforcement
Administration (DEA) to handle Schedule II through V controlled substances.

OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry.

Renowned for its expertise in difficult-to-manufacture, demanding or highly potent products, OsoBio is well suited to handle controlled substances, said Dr. Stuart Rose, president and CEO.

“As a highly disciplined organization, OsoBio is comfortable with the processes, controls and documentation required when working with especially sensitive pharmaceutical materials,” he said. “We do the work that’s difficult to do.”

The DEA places strict guidelines on the research, manufacture and distribution of controlled substances to prevent their diversion into illicit markets. The agency categorizes controlled substances according to each one’s respective use in medical treatment, as well as its potential for abuse or causing dependence.

The agency approved OsoBio’s registration application to conduct research and perform analytical testing related to the potential manufacture of Schedule II through V controlled substances for clients.

“There aren’t many companies in the United States capable of producing injectable controlled drugs, so we’ve already fielded a number of calls from clients who have that need,” Rose said. “As we broaden OsoBio’s capabilities in handling products that demand special attention, we demonstrate our continued confidence that our company will exceed quality assurance and regulatory compliance expectations.”

OsoBio is a contract manufacturing organization focusing on biologic and pharmaceutical injectables. Headquartered in Albuquerque, N.M., OsoBio and its employees provide innovative solutions to clients’ most difficult projects. To learn more, visit http://www.OsoBio.com

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