Tablets & Capsules

TC0715

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USP proposes guidelines to curtail drug-contaminated supplements ROCKVILLE, MD—In response to fre- quent violations involving dietary supple- ments found to be adulterated with unde- clared pharmaceutical active ingredients, the United States Pharmacopeia (USP) has proposed General Chapter <2251> "Adulteration of Dietary Supplements with Drugs and Drug Analogs." The chapter, which recommends chromato- graphic, spectroscopic, and biological assays to detect contaminants, is expected to be available for review this month in the USP Pharmacopeial Forum. Lilly to establish drug innovation center in Cambridge, MA INDIANAPOLIS, IN—Eli Lilly plans to build a drug delivery and device innova- tion center in Cambridge, MA. Lilly CEO John C. Lechleiter said the location strategically "provides us access to a con- centration of high-caliber academic insti- tutions, cutting-edge life science and technology companies, and some of the world's leading talent." IPEC releases position paper on EU risk-assessment guidelines BRUSSELS, Belgium—The International Pharmaceutical Excipients Council (IPEC) Federation published a three-page position paper on EU guidelines for excipients. While IPEC endorses the EU's risk-based approach following ICH Q9 principles of quality risk management, the paper raises concerns that there may not be sufficient time to complete risk assess- ments for all excipients by the March 21, 2016 deadline. The paper also stated that incomplete assessments may "jeopardize the availability of high-quality excipients that have been in use for many years." NSF renames excipient auditing business ANN ARBOR, MI—NSF International's business unit formerly known as Interna- tional Pharmaceutical Excipient Auditing (IPEA) has been renamed NSF Excipient Certification Program (NSF-ECP). The change follows the release of NSF/IPEC/ANSI 363 Good Manufacturing Practice for Pharmaceutical Excipients. NSF-ECP will begin using the new stan- dard August 1, 2015. For information about the standard, see the article on page 14. Rx-360 offers audit reports, forms India working group WASHINGTON, DC—Rx-360, a group dedicated to supply-chain safety, is offer- ing audit reports of suppliers. A list of audit reports available for purchase appears at rx-360.org. In other news, Rx- 360 formed Asia Working Group-India to help identify and mitigate root causes of quality problems and supply-chain secu- rity in that country. Briefly noted… The FDA approved the first ge ne - ric versions of Abilify (aripiprazole), an antipsychotic approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals, Hetero Labs, Teva, and Torrent Pharma - ceuticals may market generic aripipra- zole in multiple strengths and dosage forms. The FDA also ap proved the first generic of Inter mezzo (zolpidem tartrate) sublingual tablets for treating insomnia. Novel Pharmaceuticals received the approval in early June. 8 July 2015 Tablets & Capsules Qualicaps ® New Imprinting Equipment has Laser Focus Introducing the LIS-250 UV Laser Imprinting System for Tablets, Softgels and Capsules Qualicaps.com Follow Us: @Qualicaps Why Laser? • Defects caused by ink (double print, ink spots, missing print, etc.) are eliminated • CAD design allows for flexible imprinting options • Eliminates the need for print rolls, ink and extra storage, reducing the run cost of imprinting • No cleaning necessary due to the lack of ink • Larger printable surface than ink printing • Potential for the prevention of counterfeiting • Non-thermal effects of UV laser allow marking without resulting in thermal denaturation on tablets For more information on Qualicaps complete line of processing FRVJQNFOUæMMJOH band-sealing and inspection, visit:

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