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SPL in Medical News

Data Conversion Laboratory Supports Newest SPL Requirements For Life Sciences Industry

FRESH MEADOWS, N.Y., Aug. 4 /PRNewswire/ -- Data Conversion Laboratory, Inc. (DCL) , providing conversion services and software to publishers, information aggregators, industry, government, libraries and documentation developers, continues to be in the forefront supporting the life scien...

DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing

...-FDA and Industry: Overview and Lessons Learned on spl (August 11-12; Philadelphia, PA) The FD... Validation rules applied by FDA Nuances of spl lifecycle management, including findings from the ...isting pilot and early production submissions. spl Release 4 terminology Product listing and esta...

Starpharma and Elanco Sign Agreement

...ited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. spl has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on SPL's dendrimer technology are alr...

DCL Extends Structured Product Labeling (SPL) Services to Meet New FDA Requirements; Support Now Offered for CDER, CBER, CDRH, CVM and ONP Products

...o meet the recently announced FDA requirements for spl submissions of CDER (Human Prescription Drugs), C...o meet the recently announced FDA requirements for spl submissions of CDER (Human Prescription Drugs), C..., and ONP (Over-the-Counter) products. While spl has been required for CDER products for three year...

FDA: Contaminated Heparin Found in 11 Countries

..., the FDA issued a warning letter to the Changzhou spl Company Ltd., which supplies heparin to Baxter Int...or third-party audits of the facility... Changzhou spl is committed to cooperating with FDA and will prom...rovide a detailed response to the warning letter," spl said in a prepared statement. The statement add...

FDA: Contaminated Heparin Found in 10 Countries

..., the FDA issued a warning letter to the Changzhou spl Company Ltd., which supplies heparin to Baxter Int...or third-party audits of the facility... Changzhou spl is committed to cooperating with FDA and will prom...rovide a detailed response to the warning letter," spl said in a prepared statement. The statement add...

FDA Identifies Contaminant in Blood-Thinning Drug

... heparin when subjected to standard tests." The contaminant was found in samples of heparin that the FDA tested from Scientific Protein's Changzhou spl plant in China, which supplied Baxter with the active ingredient in heparin, Woodcock said. It was also found in Baxter's heparin products in the Unit...

Blood-Thinner Contaminant Traced to Chinese Plant

...Laboratories of Waunakee, Wisc., and its Changzhou spl plant in Changzhou City, China. The company is Bax...pharmaceutical ingredient comes from the Changzhou spl plant in China," Dr. Janet Woodcock, director of t...t of the finding, the FDA has placed the Changzhou spl plant on "import alert," Woodcock said, meaning th...

Heparin Problems Reported in Germany

...rin came from China." Scientific Protein Laboratories and its Changzhou spl plant in Changzhou City, China, is Baxter's main supplier of the active pha...n active pharmaceutical ingredient (API) sourced from China and provided by spl to Baxter is responsible for these adverse events." Contaminated produc...

FDA Finds Contaminant in Baxter's Recalled Heparin Products

...aboratories, of Waunakee, Wisc., and its Changzhou spl plant in Changzhou City, China, is Baxter's main s...ngredient (API) sourced from China and provided by spl to Baxter is responsible for these adverse events....that this theory is speculation at this point, and spl is participating actively in working with the FDA ...

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SPL in Biological Technology

Glemser Announces New Labeling Solution: SPL for DCM Addresses New SPL Release 4 Requirements

Glemser Technologies, a Bethlehem, PA based pharmaceutical software and services company, today announced SPL for DCM, a new out-of-the-box labeling solution based on Documentum's Documentum Compliance Manager (DCM) application. SPL for DCM provides a complete labeling content management solutio...

Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies

...suite includes: Regulatory eCompliance Products Virtx spl - Labeling application that complies with US FDA spl R4 and PLR formats Virtx eCTD - eCTD builder, viewer and publisher ...

Event Alert: 'SPL R4 Compliance and its Impact on Regulatory Submission Processes'

...inar "How Organizations Can Make the Transition to spl R4 Compliance," Hosted by Pilgrim Software and fea... host a complimentary Webinar on best practices in spl R4 compliance and how organizations can make the n...ems or evaluating new technologies to meet the new spl R4 requirements. The webinar is designed as a "ho...

Iowa Resident Dies After Using Contaminated Blood Thinner

...t that the FDA was not doing significant inspections) required the need for more sensitive testing. According to the FDA's inspection, the Changzhou spl Facility was unable to provide FDA with any assurance "that processing steps used to manufacture heparin sodium, USP are capable of effectively removi...

Illinois Pharmaceutical Manufacturer Sued for Injuries to Kentucky Resident

...act that the FDA was not doing significant inspections) required the need for more sensitive testing. According to the FDA inspection, the Changzhou spl Facility was unable to provide FDA with any assurance "that processing steps used to manufacture heparin sodium, USP are capable of effectively removi...

Alfacell Announces ONCONASE(R) Purchase and Supply Agreement with Scientific Protein Laboratories

...erformance of the extremely well qualified team at spl for many years and are confident that the commerci...y. Beyond supplying high quality proprietary APIs, spl provides contract process development and cGMP man...roducts extraction, fermentation and purification. spl is among a small number of companies that have suc...

Scientific Protein Laboratories Acquired by New York firm

...ture anticoagulants used in the prevention and treatment of thrombosis, embolism, acute coronary syndromes and surgical recoveries involving implants. spl also manufactures pancreatin API, which is used to treat pancreatic deficiency of cystic fibrosis and a variety of digestive disorders. We look fo...

Protein lab could prosper under new owner

..., some of the drug candidates partially comprising spl ingredients could earn federal regulatory approval...t niche products and services companies, purchased spl for $81 million. SPL has 121 employees and owns...PL, is the product of a 1999 joint venture between spl and Techpool Bio-Pharma Co., Ltd. The new owne...

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