Packaging, Labeling, and Distribution Systems

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

Recent trends in raw materials packaging may impact manufacturing, quality, and cost of biopharmaceuticals.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Lawsuit alleges birth control packaging error led to 113 unwanted pregnancies.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

Avantor released a packaging platform that allows for the direct dispensing of chemicals-such as salts, buffers, and cell culture ingredients-into processing equipment.

Product labels should include more information on extrapolation, interchangeability, and the original source of clinical trial data, according to a survey of those in charge of dispensing medications.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

Drug makers back alternative to FDA labeling update rule.

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

Manufacturers are taking measures to comply with new package safety rules.

A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.