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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...

PharmTech

 •  January 4

On Jan. 4, 2018, contract manufacturer Wuxi Griffin announced the completion of a new 27,450-ft2 aseptic fill/finish facility in Wuxi, China. The facility is equipped with three filling suits and uses restricted access barrier systems and isolator production technology. According to the company, the facility is compliant with GMP standards and...

PharmTech

 •  January 3

The agency published draft guidance on good practices for submitting abbreviated new drug applications. On Jan. 3, 2018, FDA published draft guidance detailing good practices for the submission of abbreviated new drug applications (ANDAs) as part of its Drug Competition Action Plan. In the guidance document, the agency highlights common...

PharmTech

 •  January 2

PharMEDium Services, LLC announced on Dec. 27, 2017 that it was voluntarily recalling certain lots of product because of a lack of sterility assurance. The recall was issued after an FDA inspection of the company’s Memphis location led to the agency requesting the company perform a review of all commercially distributed product compounded at the...