The new DEA registration status is the result of a concerted effort to enhance infrastructure and adopt procedural controls that facilitate compliance with DEA requirements. The ability to manufacture controlled substances affords the company additional capacity when added to the pre-existing controlled substance manufacturing capabilities at its Grafton, Wisconsin facility.

“The GMP manufacturing and analytical method development expertise of Cedarburg Hauser’s Denver facility may now be extended to DEA scheduled compounds” says Vice President and General Manager, Joe Guiles. “This further emphasizes these competencies, and represents an opportunity to expand our customer base and serve the needs of our existing customers.”

“The development and manufacturing of controlled substances requires stringent controls and security measures” added Dan Childers, VP of Quality Assurance and Regulatory Compliance. “DEA registration further illustrates the strength of the manufacturing, handling and storage controls in place at Cedarburg Hauser’s Denver facility.”

The registration is filed under InB: Hauser Pharmaceutical Services, and allows for the immediate manufacture of schedule II-V compounds.

About Cedarburg Hauser Pharmaceuticals

Cedarburg Hauser Pharmaceuticals is an experienced, contract development and manufacturing organization (CDMO), specializing in small molecule active pharmaceutical ingredients (API) and pharmaceutical intermediates. Cedarburg Hauser leverages a talented group of scientists and supporting -staff, as well as a centralized approach to project management, to ensure on-time and on-budget completion of projects involving the development, scale-up, and manufacturing of complex APIs.

The post Cedarburg Hauser Granted DEA Registration for Denver Manufacturing Facility appeared first on Cedarburg Hauser Pharmaceuticals.

Event: DCAT Week 2013
Dates: March 11-14
Location: New York, NY
Suite: Kimberly Hotel – 145 E. 50th Street

Cedarburg Hauser Pharmaceuticals will be attending DCAT Week ’13 in New York, NY.  The meeting will be held from March 11-14 and is based out of the Waldorf Astoria. Attendees are invited to schedule a meeting with Cedarburg Hauser at our suite in the near by Kimberly Hotel to learn about our API development and manufacturing capabilities.

To schedule a meeting with our team, please fill out the short form below. A member of our team will contact you in a timely manner to schedule a meeting.

Schedule a Meeting

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Event: InformEx USA 2013
Dates: February 19-22, 2013
Location: Anaheim, CA
Booth:# 1207

Cedarburg Hauser Pharmaceuticals will be exhibiting at InformEx USA in Anaheim, CA.  The exhibition will be held February 20-22nd with showcases held on February 19th. Attendees are invited to visit Cedarburg Hauser’s booth (#1207) to learn about our API development and manufacturing capabilities.

To schedule a meeting with our team, please fill out the short form below. A member of our team will contact you in a timely manner to schedule a meeting.

Schedule a Meeting

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Dr. Lynch has served as Cedarburg Hauser’s Director of Research and Development for the last three years, where he oversaw development projects and led a staff of scientists. Prior to joining Cedarburg Hauser, Dr. Lynch spent 15 years at Abbott Laboratories, working on a variety of process development and medicinal chemistry projects.

“Dr. Lynch’s promotion is well deserved” says Cedarburg Hauser’s CEO, Tony Laughrey. “In his time at Cedarburg Hauser, John has successfully led Cedarburg Hauser’s research and development efforts and is the ideal person to head-up the company’s scientific operations.”

“Dr. Lynch is a very talented chemist with a real aptitude for identifying problematic areas in an industrial process and optimizing reaction conditions “ added Chuck Boland, Executive Vice President. “These skills have allowed Cedarburg Hauser to save our clients time and money, increasing yields and improving performance.”

In his new role, Dr. Lynch will oversee all scientific operations including the process development, R&D and analytical groups. Dr. Lynch holds a Ph.D. in organic chemistry from Harvard University where he studied under Prof. David Evans, and also holds a B.S. from the University of Wisconsin – Madison.

About Cedarburg Hauser Pharmaceuticals

Cedarburg Hauser Pharmaceuticals is an experienced, contract development and manufacturing organization (CDMO), specializing in small molecule active pharmaceutical ingredients (API) and pharmaceutical intermediates. Cedarburg Hauser leverages a talented group of scientists and supporting -staff, as well as a centralized approach to project management, to ensure on-time and on-budget completion of projects involving the development, scale-up, and manufacturing of complex APIs.

The post Cedarburg Hauser Promotes John K. Lynch to Chief Scientific Officer appeared first on Cedarburg Hauser Pharmaceuticals.

Grafton, WI (September 25, 2012) – Cedarburg Hauser Pharmaceuticals (CHP) has expanded the capacity of its Wisconsin based active pharmaceutical ingredient (API) manufacturing plant. The expansion efforts are a result of an increased demand for contract manufacturing of commercial APIs and are accompanied by additional upgrades aimed at improving safety and GMP systems.

“These improvements increase our total reactor capacity by nearly 50%” says John Flahive, Cedarburg Hauser’s newly hired Director of Operations. “We have also added a reactor and chiller that allow for cryogenic reactions in our GMP labs.”

In addition to the new reactors, Cedarburg Hauser has also made improvements to the air handling systems in the GMP manufacturing suites, installed a reverse osmosis water system, improved isolation capabilities, and upgraded their Emerson DeltaV Digital Automation System.

“The added reactor capacity and upgrades to existing safety and GMP systems are the latest example of Cedarburg Hauser’s continued commitment to serving the commercial API marketplace” commented CEO Tony Laughrey. “The flexibility afforded by the additional reactor capacity allows us to better meet our customer’s on-time and on-budget requirements” Laughrey continued.  “We will continue to invest in our business as we strive to be the premier contract API manufacturer.”

About Cedarburg Hauser Pharmaceuticals

Cedarburg Hauser Pharmaceuticals is an experienced, contract development and manufacturing organization (CDMO), specializing in small molecule active pharmaceutical ingredients (API) and pharmaceutical intermediates. Cedarburg Hauser leverages a talented group of scientists and supporting staff, as well as a centralized approach to project management, to ensure on-time and on-budget completion of projects involving the development, scale-up, and manufacturing of complex APIs.

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Event: IVT’s 9th Method Development & Validation Conference
Dates: September 11-13, 2012
Location: Philadelphia, PA

Dr. Rafail Usatinsky (Manager, QC & Analytical Services) leading a Workshop at the Institute of Validation’s 9th Annual Method Development & Validation Conference. The workshop, titled Pharmaceutical Impurities Identification: Method Development Strategies to Ensure Compliant and Efficient Processes are in Place, will took place on Wednesday, September 12th.

It was be divided into four sections:

1. Classification of Pharmaceutical Impurities
2. Regulatory Requirement for Pharmaceutical Impurities
3. Identification of Pharmaceutical Impurities
4. Pharmaceutical Impurity Case Studies

Didn’t make the workshop? Simply fill out the simple request form below to request a copy Dr. Usatinsky’s presentation.

Request a Copy of the Workshop Presentation

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Event: CPhI World-Wide 2012
Dates: October 9-11, 2012
Location: Madrid, Spain

Cedarburg Hauser Pharmaceuticals will be attending CPhI World-Wide 2012 in Madrid, Spain. Cedarburg Hauser will be represented at the show by our CEO, Executive Vice President, and Director of Project Management. To schedule a meeting with our team, please fill out the short form below. A member of our team will get back to you in a timely manner to schedule a meeting.

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Grafton, WI – Cedarburg Hauser Pharmaceuticals, a contract development & manufacturing organization (CDMO) specializing in active pharmaceutical ingredients, has received the Metropolitan Milwaukee Association of Commerce (MMAC) Future 50 Award. The future 50 award recognizes the achievements of privately-owned business in the seven county Milwaukee region that have shown significant revenue and employment growth. A special thanks to our customers and employees for their continued support. We look forward to continuing to serve your API development and manufacturing needs in the future.

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Dr. Joe Guiles, Vice President and General Manager at Cedarburg Hauser Pharmaceuticals, will be presenting a poster titled “Current Peptide-Drug Conjugates & Early Stage Manufacturing Considerations” at TIDES: Oligonucleotide & Peptide Research, Technology & Product Development, held in Las Vegas, NV, May 20-23. This is the latest in a series of informational pieces that Cedarburg Hauser has developed on peptide-drug conjugates.

In addition to the TIDES poster, Cedarburg Hauser has published an article in the May issue of Specialty Chemical Magazine on the topic. The article, titled “Peptide-drug conjugates: Types, utility & manufacturing” looks at the composition, chemical assembly and manufacturing challenges of these exciting pharmaceuticals.

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In an article posted on October 6th, FiercePharma Manufacturing, a leading pharmaceutical electronic trade publication, named Cedarburg Hauser Pharmaceuticals one of the “Top 10 Standout CMOs”.

FiercePharma Manufacturing worked with respected pharmaceutical industry research company, Nice Insight, to come up with the Top 10 list based on their database of CMOs that have been rated on client perception and awareness. Nice Insight also analyzed their database to find the top rated companies based on five core contract manufacturing functions including:

1. Process optimization
2. Lyophilization
3. Fill/finish
4. Packaging
5. Stability, storage and testing

Cedarburg Hauser’s hard work and dedication to our clients continues to pay off as Nice Insight’s client perception ratings have continued to climb in 2011.  Our rating for Q3 is 75% – up 3 points over Q2 and up 11 points over Q1!

We are proud of the work we do for our clients. Our dedication to helping our clients successfully achieve their scientific goals within their timeline and budget is what has helped us continue to increase our ratings and be recognized by FiercePharma Manufacturing as one of the Top 10 Standout CMOs in the industry.

Please contact us to talk about your current or upcoming API development and manufacturing project and let us show you why we’re one of FiercePharma Manufacturing’s Top 10 Standout CMOs in the pharmaceutical industry.

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