Navigation Links
Manhattan Isotope Technology Completes Drug Master File With Food and Drug Administration
Date:8/23/2012

LUBBOCK, Texas, Aug. 22, 2012 /PRNewswire/ -- Positron Corporation, (OTCBB:POSC) a leading molecular imaging healthcare company, is pleased to announce the submission of a Drug Master File (DMF), with the Food and Drug Administration (FDA), for the production of Active Pharmaceutical Ingredient (API) grade strontium-82,  through its wholly owned subsidiary Manhattan Isotope Technology, LLC.

A Drug Master File (DMF) is a document submitted to the FDA, which contains complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. The DMF contains factual and complete information on a drug product's chemistry, manufacturer, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.

Manhattan Isotope's DMF submission initiates the protocol, procedures, and compliance required to produce Sr-82 for radiopharmaceutical applications, specifically for commercial use in Sr-82/Rb-82 generators.  Sr-82/Rb-82 generator manufacturers may now qualify MIT as a supply source and vendor for API grade Sr-82.   

Manhattan Isotope's DMF positions the Company as the only commercial entity in the United States in the Sr-82 processing and production arena.  Currently, the U.S. Department of Energy (DOE) is the only domestic supplier for many of the over 300 different isotopes, which are critical in medical, commercial, research, and national security applications.   Recent shortages have emphasized the importance of managing the demand for critical isotopes, substantiating Positron's timely entrance into this market. 

Jason Kitten, President of Manhattan Isotope Technology stated, "Our submission of the DMF is a very significant milestone, as it signifies Positron's evolution towards a vertically integrated nuc
'/>"/>

SOURCE Positron Corporation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Manhattan Isotope Technology Completes Drug Master File With Federal Drug Administration
2. Positron Consolidates Radiopharmaceutical & Radioisotope Facilities
3. Water Isotope Analyzer Accurately Measures Contaminated Samples
4. Interventional Spine Announces its 75th Patient Treated with the PerX360 Percutaneous Spinal Fusion Technology
5. Cancer Patients in Central Vietnam to Gain Access to Advanced Radiotherapy Treatments Using Technology from Varian Medical Systems
6. Frost & Sullivan Lauds MobileHelp for Its Outstanding Products and Performance in the North American Health Technology Market
7. Microsemis New Packaging Technology Enables Miniaturized Implantable Medical Devices
8. Golden Seeds Invests In DxUpClose, Disruptive Technology That Performs An Antibiotic Sensitivity Test At The Patients Bedside In Less Than An Hour
9. Biotechnology Thought Leader, Dr. Abbie Celniker, Joins ImaginAb Board of Directors as Chairman
10. Global Chiral Technology Industry
11. Antibiotics and Biotechnology Take Center Stage at Food Dialogues Event
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... -- In the Friday, December 19 edition of USA ... Technology (HIT) features Konica Minolta, the company announced today. The supplement ... leading healthcare organizations. In addition to the print ... as New York , Chicago ... Minneapolis and San Francisco ...
(Date:12/19/2014)... 19, 2014 TODAY, AEGATE, the ... World announced the appointment of Peter Fox ... Chief Channels and Partner Officer. Peter has ... to its acquisition by Oracle in 2011. ... Geneva and subsequently Convergys, a world ...
(Date:12/19/2014)... , Dec. 19, 2014  Newport Corporation (NASDAQ: ... Kadia, Ph.D. has joined the company,s Board of ... Officer and a director of Evans Analytical Group, ... evaluation and analytical services to companies in a ... to joining Evans Analytical Group, Dr. Kadia spent ...
Breaking Medicine Technology:USA Today Supplement Featuring Konica Minolta Focuses on Impact of Healthcare IT 2Aegate Appoints new CTO and Chief Channels & Partner Officer 2Aegate Appoints new CTO and Chief Channels & Partner Officer 3Aegate Appoints new CTO and Chief Channels & Partner Officer 4Siddhartha Kadia, Ph.D. Joins Board of Directors of Newport Corporation 2
... Amarin Corporation plc (Nasdaq: AMRN ) ... on cardiovascular disease, today announced that, in connection with ... Shares ("ADSs"), the underwriters of the offering have exercised ... aggregate of 1,800,000 additional ADSs to cover over-allotments.  The ...
... 7, 2011 Echo Therapeutics, Inc. (OTC Bulletin Board: ... Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous ... transdermal drug delivery, today announced that Patrick T. Mooney, ... Echo Therapeutics will present at the OneMedForum 2011 annual ...
Cached Medicine Technology:Amarin Announces Underwriters' Exercise of Over-Allotment Option 2Amarin Announces Underwriters' Exercise of Over-Allotment Option 3Amarin Announces Underwriters' Exercise of Over-Allotment Option 4Echo Therapeutics to Present at the OneMedForum 2011 Conference 2
(Date:12/19/2014)... Surviving Mesothelioma says thousands of water pipes in the ... can leach asbestos into drinking water as they age. ... the Surviving Mesothelioma website. , According to the EPA, ... water mains made of asbestos cement are the major source ... consumers from mesothelioma , water providers are subject to routine ...
(Date:12/19/2014)... B. E. Smith, the only full-service ... been retained to lead a national chief financial ... Estes Park, Colo. The top executive search firm in ... more than 900 healthcare executives into organizations. , ... critical access hospital and level IV trauma center, with ...
(Date:12/19/2014)... December 19, 2014 Novellus Healthcare ... Care: Pharmacy & Clinics™, an independent journal that ... treating and caring for patients inside the pharmacy ... expands to provide optimal access to quality care, ... forum for the team treating and coordinating patient ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 If you ... having difficulty breathing, you probably wished you had an ... asthma, COPD, cystic fibrosis, and other breathing disorders. Currently, ... medications and avoiding triggers, but other common treatments do ... Educators conference in San Antonio, TX, 34 asthma educators ...
(Date:12/19/2014)... December 19, 2014 After a 13-year ... is again returning to the stage to entertain his ... for concert performances, and the successful tour has been ... announced. , Visit Ticketability.com for a ... Detroit shows at fair prices. , Music fans have ...
Breaking Medicine News(10 mins):Health News:Surviving Mesothelioma Warns of Potential Mesothelioma Risk from Cement Water Pipes 2Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 2Health News:Estes Park Medical Center Retains B. E. Smith to Recruit New Chief Financial Officer 3Health News:The Transformation of Retail Pharmacies into a Healthcare Delivery Center 2Health News:The Transformation of Retail Pharmacies into a Healthcare Delivery Center 3Health News:Harmonica Techs, Inventors of the Pulmonica®, Unveil New Findings on Complementary Treatments for Asthma 2Health News:Harmonica Techs, Inventors of the Pulmonica®, Unveil New Findings on Complementary Treatments for Asthma 3Health News:Garth Brooks Tickets for Joe Louis Arena: Ticketability.com Becomes a Popular Destination for Discount Tickets for Garth Brooks’ Detroit Concerts Set for February 27-28 2
... ... cut down on road accidents , ... York, New York (PRWEB) March 26, 2010 -- With the arrival of spring, more cyclists are ... an increasing number of people sharing the road with drivers and pedestrians., , , , ,This ...
... ... relax patients, treat TMJ disorders and improve dental procedures. , ... Miami, FLA. (PRWEB) -- In addition to cosmetic dentistry services, ... at Miami Beach Dental Institute now offer dental massage to patients. Dr. Nassery teams up ...
... Barcelona, Spain: Women who discover they have breast cancer ... without endangering the health of their unborn baby, according ... Breast Cancer Conference (EBCC7) in Barcelona today (Friday). ... at the University of Frankfurt, Germany, and a member ...
... Mexican Americans are 40 percent less likely than non-Hispanic whites ... ambulance for stroke resulting in medical treatment delays ... of the American Heart Association ., For the study, researchers ... Texas (BASIC project) to compare hospital arrival time and use ...
... with a coalition of 20 international sites in five ... who have had optical coherence tomography (OCT) of the ... researchers hope will give doctors a better means to ... and sudden cardiac death. When a vulnerable ...
... researchers say , THURSDAY, March 25 (HealthDay News) -- New ... breast cancer may actually improve their survival odds, a notion ... The finding is significant, given that the death rate from ... delaying pregnancy until later in life, the study authors said. ...
Cached Medicine News:Health News:New York Personal Injury Attorney Interprets Increase in Tickets for Cyclists as Effort to Make Streets Safer 2Health News:Top Miami Dentist, Dr. Hamid Nassery, Offers Dental Massage Services For Patients 2Health News:Pregnant women can receive breast cancer chemotherapy without endangering health of their babies 2Health News:Pregnant women can receive breast cancer chemotherapy without endangering health of their babies 3Health News:Mexican Americans less likely than whites to call 9-1-1 for stroke 2Health News:Mexican Americans less likely than whites to call 9-1-1 for stroke 3Health News:Mass. General Hospital to create registry for coronary optical coherence tomography 2Health News:Pregnancy May Protect Breast Cancer Survivors 2Health News:Pregnancy May Protect Breast Cancer Survivors 3
Inquire...
... offered as either EDTA K2 or ... calcium ions and therefore blocks the ... in an EDTA anticoagulated blood sample ... hours. EDTA tubes are for the ...
... is a ubiquitous enzyme that catalyzes ... is also the specific protein that ... immunofluorescence (EMA) tests (Bio-Rad catalog number ... IgG serologic tests are highly sensitive ...
We offer small and large pre-gelled Surface Electrodes suitable for EMG or EGG recordings....
Medicine Products: