Packaging, Labeling, and Distribution Systems

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

The approval marks the first time a new glass composition has been approved by FDA since the approval of borosilicate glass more than 100 years ago.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.

Cloudleaf's Digital Visibility Platform can track which track location and additional environmental information, such as temperature, vibration, and shock, of sensors placed on raw material containers.

The company will supply its heparin sodium injection in prefilled syringe form.

Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

A UK-based company, Atelerix, has revealed that it has closed a second round of funding worth £700,000 (US$911,000).

Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.

Legacy Pharmaceuticals has entered into a collaboration with SCHOTT to solve a technical challenge of leaching that is occurring with an antiviral drug.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

GS1, a global supply-chain standards organization, launched a new messaging standard in collaboration with GS1 US to help meet the requirements of the US Drug Supply Chain Security Act (DSCSA) for salable returns of serialized prescription drugs.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

PCI Pharma Services expanded capacity of its commercial packaging site in Illinois.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.

The company will complete an expansion of its secondary packaging capabilities at its Ravensburg, Germany site by 2020.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

ICS distribution center will serve manufacturers of specialty medications, biosimilars, and cell and gene therapies.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.