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Message: PharmEng Receives Establishment License From Health Canada for New Facility in S

PharmEng Receives Establishment License From Health Canada for New Facility in S

posted on Nov 07, 2008 07:38AM
PharmEng Receives Establishment License From Health Canada for New Facility in Sydney, Nova Scotia

PharmEng International Inc. ("PharmEng") (TSX VENTURE: PII), today announced that its wholly owned subsidiary, Keata Pharma Inc. ("Keata"), received a drug establishment license on June 26, 2008 for its manufacturing facility located in Sydney, Nova Scotia.

The establishment license was issued after a Good Manufacturing Practices (GMP) inspection was conducted under the authority of the Food and Drugs Act to verify compliance with the applicable regulations. The inspection concluded favourably on June 13,2008. The establishment license is for the manufacturing, testing and packaging of the following drug dosage forms; capsules, powders, solutions and tablets.


Following the inspection, the Sydney site was also recommended for the issuance of a Controlled Substance License. The facility is anticipating the imminent issuance of its Natural Health Product Site License, and it's Precursor License, according to the Natural Health Products Regulations, and the Controlled Drugs and Substances Act, respectively. These additional licenses will permit the facility to market natural health products and to broaden the portfolio of Controlled Substances that it currently handles.

As a result of the issuance of the establishment license, the Sydney facility has begun commercial production with shipping of product commencing immediately.

"Being issued a Drug Establishment License for Sydney is a milestone achievement and is the culmination or several years of strategic planning by the combined resources of our consulting group and the Keata team," states David Leonard, President of the Sydney facility. "The Sydney facility is a new state-of-the-art pharmaceutical manufacturing facility with the unique capability to assist clients to bring their products from the laboratory to the market by providing development, scale-up and commercial production expertise. The issuance of these licenses coupled with our low cost pharmaceutical production sets the stage for significant growth in the future." concludes Mr. Leonard.

The 46,400 sq. ft. Sydney facility includes pilot laboratories for formulation development, rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technology. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms.

The Sydney site also includes offices for PharmEng's pharmaceutical consulting division. Keata's long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals and injectables. The facility is located on five acres in the Northside Industrial Park, a 300 acre business park in North Sydney, NS.

About PharmEng International Inc.

PharmEng International Inc., headquartered in Toronto, Canada, is a full-service consulting and contract manufacturing company that serves the pharmaceutical and biotechnology industries in North America and internationally. Consulting services include project management, engineering, GMP, validation, calibration, regulatory compliance and certified training. Contract manufacturing includes pharmaceutical support, formulation development, laboratory testing, and finished solid dosage and liquid products. PharmEng's shares trade on the TSX Venture Exchange under the symbol PII. For more information about PharmEng International Inc. (TSX-V: PII), visit the Company's website at www.pharmeng.com.

FORWARD LOOKING STATEMENTS

Certain statements in this press release may include "forward-looking" statements which involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements of PharmEng to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. When used in this press release, such statements use such words as "may", "will", "expect", "anticipate", "project", "believe", "plan", and other similar terminology. The risks and uncertainties are detailed from time to time in reports filed by PharmEng with the securities regulatory authorities in all of the provinces and territories of Canada. New risk factors may arise from time to time and it is not possible for management to predict all of those risk factors or the extent to which any factor or combination of factors may cause actual results, performance and achievements of PharmEng to be materially different from those contained in forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction actual results.


Contacts:
PharmEng International Inc.
Charles Ivey
Vice President
(905) 415-3922 x 116
Email: [email protected]
Website: www.pharmeng.com

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