Gorbec goes Global
_ www.gorbec.cn
Home Page
News & Events
Our Services
Corporate Facility
Executive Bios
Contact Gorbec
Gorbec Blog
News Dec 6, 2010
Clean bill of health
Decmber 2010FDA GMP audit yields no 483 observations!
Gorbec Pharmaceutical Services, Inc.
We deliver quality contract pharmaceutical services to clients with an understanding for producing cost effective solutions that fill a market need in a timely manner.
Gorbec Pharmaceutical Services Inc. was founded on January 1, 2007 by sole proprietor and businessman Mike Gorman, with a purpose of offering a broad range of services in support of the drug development process. Our goal is to transform your concept into a product that meets FDA requirements and your performance criteria, while working within a timeline and a budget.
Our focus is on the segment of small volume niche drugs that treat narrowly defined conditions and disease states, recognizing that most large facilities can not cost effectively handle these types of products. We can guide your product through the developmental stages, offering analytical support, scale-up, pilot plant manufacturing, and electronic FDA submission.
We have Low EPA DHA!
E-mail info_gorbec.com to find out more
"Good Science Driven By
Smart Business"
Gorbec Pharmaceutical Services, Inc. has provided a new corporate blog in which the company and clients can interact and stay informed on current events and news about our company as well
as the pharmaceutical industry.
Feel free to send us a message, provide industry insight or just say "hello" at the link provided below:
"Good Science
driven by
December 6, 2010
FDA audit yields zero 483 Observations
An FDA compliance inspector visited Gorbec's facility on December 4th as a follow up to an inspection earlier this year that produced multiple 483 observations. The purpose of the inspection was to verify that adequate corrective mesaures to the points identified were taken. The inspector left satisfied on Wednesday, issuing no observations and applauding Gorbec's team for such a "proactive and agressive" approach. With this inspection behind them, Gorbec's management believes that its first ANDA approval could come any day.
September 22 - 23, 2010
Gorbec VP's attend CONTRACT PHARMA conference 2010
http://www.contractpharma.com/2010conference
"Contract Pharma magazine announces its 9th Annual Contracting and Outsourcing Conference and Tabletop Exhibition, devoted to outsourcing in the pharma and biopharmaceutical industries. The event will be held on September 23-24, 2010 at the Hyatt Regency New Brunswick, NJ, located in the heart of New Jerseys pharmaceutical industry. The tabletop exhibition will be held one day only on Thursday, September 23rd with additional sessions held on Friday, September 24th."
April 20th, 2010
Gorbec Attends INTERPHEX 2010!
"Thousands of Pharmaceutical and Biotechnology Industry Professionals gather annually at INTERPHEX to meet one-on-one with technical experts, see the newest products and equipment, view live demonstrations, network, get expert advice to specific challenges, find resources and source new products, learn about emerging or changing trends, and to stay on top of every issue surrounding life sciences manufacturing." http://www.interphex.com/en/Home/
February 4th, 2010
GORBEC PHARMACEUTICAL SERVICES, INC ANNOUNCES THE LAUNCH OF ITS GMP ANALYTICAL LABORATORY IN CHINA
DURHAM, N.C., Feb. 4 /PRNewswire/ -- Gorbec Pharmaceutical Services, a rapidly expanding contract developer and manufacturer of prescription pharmaceutical products, is opening a GMP-compliant analytical laboratory in Yantai, China. This new facility will expand Gorbec's current services for analytical method development and testing. Gorbec is taking this action to better serve its U.S. customer base as well as develop a presence in the emerging Asian market.
Gorbec currently provides complete development, regulatory, analytical, and manufacturing services for U.S.-based customers. Gorbec's future plans call for an increased capacity to develop and submit New Drug Applications (NDA'S) and will require an expansion of analytical services. In an effort to improve efficiencies and reduce costs, the company has elected to locate the new analytical facility in China. The company's core business services, current analytical laboratory, and commercial manufacturing will remain in the U.S. The China facility is expected to open May 1st, 2010 but Gorbec is already working with customers who have plans to use some of the new facility's capacity.
The Yantai facility will operate under the direction of Gorbec's Vice President of Analytical Chemistry, Dr. Jing Chen. Dr. Chen received her PhD from Stanford University and brings a wealth of pharmaceutical experience to the operation. She joined Gorbec after holding various positions at Genentech Inc. and Alza Corporation. Working with Dr. Chen will be Yan Zhang who will oversee the daily operations locally in Yantai.
Gorbec's Founder and CEO, Mike Gorman added, "We are very excited about our future and our ability to offer a GMP laboratory in China. This new location will allow us to serve our own needs as well as the needs of companies looking to develop and distribute pharmaceutical products for the Asian Market."
About Gorbec
Gorbec Pharmaceutical Services, Inc. is a privately held company providing complete pharmaceutical development and manufacturing services. Gorbec's highly experienced management team has driven the company to become a leader in the field of cGMP contract manufacturing services. The company is focused primarily on the development of new drug products that fill specialty niches within the traditional segment of the pharmaceutical business.
SOURCE Gorbec Pharmaceutical Services, Inc.
Gorbec Pharmaceutical Services, Inc. has gone global. Gorbec has
recently opened a facility in China.
Check us out at www.gorbec.cn
Request A Quote:
To request a quote from Gorbec Pharmaceutical Services, Inc. please fill out the form provided
and email your quote to us. We
will process the information and contact you with details.
order request form
Product Development
Gorbec provides complete formulation development services for topical and oral products including liquid, semisolid and solid dosage forms with an emphasis on guiding your product through the ANDA, 510(k), 505(b)(1) and 505(b)(2) NDA submission process. Formulation services include:
Analytical Services
To compliment our product development team, we have a fully staffed analytical R&D department equipped with all the necessary tools and expertise to support any analytical needs including:
- Preformulation
- De-formulation of existing products
- Stability Indicating Method Development and Validation
- Residual solvent and related compound testing
- Dissolution and Disintegration
- Physical characterization testing for solid and semi-solid
dosage forms
Quality Services
Quality is the backbone of our business. Gorbec maintains a three tier quality department comprised of Quality Control, Quality Assurance, and Regulatory Affairs.
- Maintains a state of control throughout the facility at all times
- Reviews and approves all SOPs and controlled documents
- Authors all FDA filings
- Interfaces with FDA
- Oversees raw material and finished goods qualification and
release
- Handles any investigations and provides corrective action
GMP Contract Manufacturing
Gorbec offers its pilot scale manufacturing capabilities on a contract basis. We support in-house product development through to commercial manufacturing, as well as the tech-transfer process.
- Pilot Batch Manufacturing
- Process and cleaning validation
- Solid dose manufacturing capabilities including tablets and
capsules
- Solution, Cream, Ointment, and Gel products supported by
validated filling systems.
- Class 100,000 modular processing rooms
- Automated Tube Filling, Packet Filling, and Bottle Filling
Equipment for high-throuput; will support low volume
products
- DEA Licensed to handle Schedule III-V finished goods
manufacturing (Schedule II-V API)
Let us take your product to market
Development - Manufacturing - Testing - Quality
- Physical characterization testing for solid and semi-solid dosage forms
- Oversees raw material and finished goods qualification and release
- Solution, Cream, Ointment, and Gel products supported by validated
filling systems.
- Automated Tube Filling, Packet Filling, and BottleFilling equipment
for high-throuput; will support low volume products as well
- DEA Licensed to handle Schedule III-V finished goods manufacturing
(Schedule II-V API)
Validated Test Methods
Below is a list of Validated Test Methods that our company has worked to achieve. We have also included a list of Preservatives and Validations "in the works."
Active Pharmaceutical Ingredients:
Acetaminophen, Butalbital, Caffeine, Tinidazole, Nitrofurantoin, Carbinoxamine, Desonide, Phenylephrine, Chlorpheniramine, Dextromethoraphan, Pramoxine, Chloroxylenol, Benzocaine, Lidocaine, Antipyrine, Flurandrenolide, Fluocinolone Acetonide, Codeine, Propoxyphene, Isoniazid, Sulfacetamide, Hydrocodone, Hydrocortisone Acetate, Benzoyl Peroxide
In the Works:
Doxycycline, Erythromycin, Griseofulvin, Desoximetasone,
API Categories:
Anti-fungal, Analgesic (Pain reliever), Cough/Cold, Steroids, Antibiotic
Preservatives:
Methyl paraben, Propyl paraben, Sodium Benzoate, Potassium Sorbate
Gorbec Pharmaceutical Services Inc. occupies a 26,600 square foot facility encompassing laboratory, manufacturing, and office space. The building is protected by ADT Security, and it runs on uninterruptible power supplies with an automatic backup generator to all critical areas. The facility is fully outfitted with oil-free compressed air and USP water filtration systems, GMP manufacturing suites, and an arsenal of analytical capability. From tube filling to tablet coating, Gorbec is able to provide the widest variety of manufacturing needs.
Gorbec has also put a strong emphasis on the latest in electronic systems for the Pharmaceutical Industry. Complete with an electronic building management system, eCTD FDA submission software, stability trending software, and MRP, Gorbec is on the cutting edge of contract pharmaceutical companies. All electronic data and systems are backed up off-site daily to ensure no loss of critical information.
J. Michael Gorman
President and CEO
Ohio State University - BS
Mike Gorman is a driven business leader with a history of successful company leadership. Since 1980, Mike has owned and operated several businesses across many different segments of industry.
In 1998, he acquired a niche cosmeceutical manufacturer in rural North Carolina called Harmony Laboratories. He transitioned the company from a manufacturer of health and beauty aids to a full scale, GMP developer and manufacturer of ethical pharmaceutical products. While at Harmony, he also developed a business of distribution and order fulfillment for certain segments of the business. During Mike's tenure at Harmony, he transformed the business from one that produced a significant operating loss to a multi-million dollar operating profit. In 2004 the company was purchased by a North Carolina investment group who continues to operate the company today.
Christopher Gorman
Vice President of Operations
Wake Forest University BA
Christopher graduated with multiple Liberal Arts degrees from Wake Forest University in Winston Salem, NC. After graduating he joined Gorbec during its infancy as the Purchasing Manager. Since that time, Christopher has climbed the ranks through Project Management and General Management, and has assisted his father in building and managing the company. Christopher now holds the position of Vice President of Operations and oversees the day to day activities of the company.
Matthew R. Popp
Vice President of Quality Operations
University of St. Thomas, MN BS
Matthew's broad pharmaceutical experience consists of analytical testing and formulation development as well as QA/QC management. Prior to joining Gorbec, Matthew was Quality Assurance Manager at Sandoz (formerly Eon Labs), where he was responsible for Quality Operations at the Wilson, NC site. Before making the transition to QA, Matthew increased headcount two fold and increased analytical throughput by more than 10 fold in his three years as Quality Control Laboratory Manager at Eon Labs. Matthews employment background also includes Magellan Laboratories, Inc., a privately held contract pharmaceutical services organization in RTP, NC, (acquired by Cardinal Health in 2002) and ethical pharmaceutical manufacturers Upsher-Smith in Minneapolis, MN, and Schwarz Pharma in Milwaukee, WI.
Jianzhuo (Jake) Wang, Ph.D.
Vice President of Research and Development
Beijing Medical University MS
University of Iowa Ph.D.
Before joining Gorbec, Jake worked as a Senior Scientist of Product Development at the Sandoz division of Novartis. His recent work focused on developing difficult-to-make generic pharmaceuticals including modified-release products. Many products that Jake has developed are either on the market or have been submitted to the FDA. Jake started his industrial career at Eon Labs as a Product Development Scientist. Eon Labs was acquired by Novartis in 2005 and merged into the Sandoz division. Jake has multiple publications in scientific journals including Journal of Pharmaceutical Sciences and Journal of Pharmacokinetics and Biopharmaceutics.
Rich Gorman
Vice President of Business Development
Rich brings over 20 years of commercial operations experience to the Gorbec team. Rich began his career at Marion Laboratories as a field sales representative. During his 13 plus years at Marion, Rich held several positions in sales, marketing, and management. After Marion, Rich spent several years at Andrx Pharmaceuticals where he was in product management as well as the head of Marketing for a new health information technology division. After Andrx, Rich worked with his brother Mike at Harmony Laboratories and at Key West Aloe. Before joining Gorbec, Rich was the President of Tiber Laboratories where he took the company from concept to a productive commercial pharmaceutical operation with over 50 representatives calling on pediatricians and dermatologists.
Contact Information:
Telephone: 1.919.281.4080
Fax: 1.919.281.4077
Address: Gorbec Pharmaceutical
Services, Inc.
2445 South Alston Avenue
Durham, NC 27713
Email: info_gorbec.com
contact information form
