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PharmTech

 •  January 16

FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates. On Jan. 16, 2018, FDA published another update on the drug shortages that are occurring because of the impact of Hurricane Maria on Puerto Rico. The agency states the shortages of IV...

PharmTech

 •  January 16

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public. On Jan. 16, 2017, the US Government Accountability Office (GAO) published a report regarding FDA’s review and approval of nonbiological complex drugs (NBCDs). The report recommends that...

PharmTech

 •  January 16

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications. On Jan. 16, 2018, Automated Control Concepts (ACC), an independent systems integrator that delivers automation and information-oriented solutions to the industrial market, announced the launch of Lab Owl, its...

PharmTech

 •  January 11

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies. Sartorius Stedim Biotech announced on Jan. 4, 2018 that it will the equipment supplier in the US for Abzena, a life sciences group that provides services and...

PharmTech

 •  January 10

The Tamper Evident Labeller from Danish labeling company LSS is in compliance with the European Falsified Medicines Directive (FMD) 2011/62/EU, which includes the requirement for tamper-proof security of cartons. The labeling machine seals the carton, and as an option, a printer and vision system of any brand can be integrated to provide each...

PharmTech

 •  January 8

Aptar’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste. The internal program, which was first introduced in 2013, is based on protocol established by the Zero Waste International Alliance Guidelines. Program...

PharmTech

 •  January 5

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018. FDA Commissioner Scott Gottlieb, MD, released a statement on Jan. 4, 2018 giving an update on recovery efforts in Puerto Rico to mitigate the intravenous (IV) saline and amino acids for...

PharmTech

 •  January 5

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval. FDA sent a warning letter, dated Jan. 3, 2018, to American CryoStem and its Chairman/CEO, John S. Arnone, for marketing an adipose-derived stem cell product without...

PharmTech

 •  January 5

A single-use DPI from Perlen Packaging, which offers lower-cost production and a more affordable device for emerging markets, won a 2017 CPhI Pharma Award. Inhalation drug products can be delivered using nebulized solutions, metered dose inhalers (MDIs), and dry powder inhalers (DPIs). MDIs and DPIs are combination products, which include both the...

PharmTech

 •  January 4

On Jan. 3, 2018, AuroMedics Pharma LLC announced it was voluntarily recalling lot AFO l 17001-A of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product is being recalled after glass particulates were found...