European Pharmaceutical Review

OCTOBER 5, 2022

For most consumers, product packaging represents their first impression of a brand and its sustainability credentials. But how is this push shaping the pharma packaging market and what are the key changes we can expect to see? For many, aesthetic appeal and user experience top the list of priorities when it comes to packaging design.

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European Pharmaceutical Review

JANUARY 9, 2025

Three industry bodies have produced a joint position paper highlighting recommendations for adopting a harmonised implementation of electronic Product Information (ePI) leaflets. It will also enable more patient-centric and accessible content by providing the most up-to-date information.

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Pharma Packaging Solutions

JULY 17, 2023

As biopharma products become more common, so must biopharma packaging. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. Here is a brief overview of biologics packaging and labeling requirements according to the Code of Federal Regulations.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

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Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. Essential Packaging Requirements Examining the arena of packaging requirements reveals many considerations.

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Pharmacy Times

JANUARY 17, 2025

If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.

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Pharma Packaging Solutions

NOVEMBER 8, 2023

Biopharma Packaging from Tjoapack Biopharmaceutical technology is advancing every day as scientists work to create new, better treatments for diseases that millions struggle with on a daily basis. With biologic treatments becoming ever more available, the need for smart, reliable biopharma packaging is on the rise.

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Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. According to its statement, PHARMAP 2024 brought together over 330 professionals from across the industry’s value chain.

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Drug Patent Watch

FEBRUARY 17, 2025

Step 2: ANDA Filing Generic drug manufacturers submit an Abbreviated New Drug Application (ANDA) to the FDA, which includes detailed information about the proposed generic drug, including its active ingredients, dosage forms, and manufacturing processes. This includes providing clear instructions for use, warnings, and precautions.

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European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

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Pharma Packaging Solutions

FEBRUARY 27, 2020

If you will be at DCAT in March, we would like to meet with you – sustainable packaging will be on the table. Our heat-sealed blister cards and folding cartons are, by their very nature, also a renewable packaging choice. And let us know what further information we can provide for a project you need.

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Pharma Packaging Solutions

SEPTEMBER 15, 2022

Pharmaceutical packaging companies play a critical role in the pharmaceutical industry. Thus, choosing a packaging company to partner with is a very important decision. When evaluating a pharmaceutical packaging company, your first order of business should be determining whether it has the capabilities to meet your specific needs.

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pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. This was an incredibly fast turnaround for what could easily have been a long and arduous onboarding process.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

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Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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GMPSOP

DECEMBER 10, 2023

Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Accurate labelling of medicines is critical to patient health.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

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Express Pharma

AUGUST 10, 2023

Real-time visibility, down to 1-2 meters within the network enabled by a mesh sensor that is affixed to the package alongside the address label. UPS Premier Gold is also available in India offering the following benefits: Visibility is integrated within all UPS tracking systems.

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European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

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Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. Failure to do so can lead to legal and financial consequences.

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NY Times

SEPTEMBER 21, 2021

The pandemic has exposed flaws in services for people who can’t easily access a drive-through window for Covid shots or testing or can’t read prescription labels.

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Drug Patent Watch

DECEMBER 12, 2024

This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more. Best Practices for Evaluation Use Industry Benchmarks Utilize industry benchmarks to inform CDMO selection. How Industry Benchmarks Can Inform CDMO Selection.

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European Pharmaceutical Review

JUNE 4, 2024

Solutions include washers, depyrogenating tunnels, liquid and powder filling and closing machines for vials, ampoules and Ready-To-Use (RTU), freeze dryers and relevant automatic loaders/unloaders, isolation technologies, labellers for vials and cartons and ancillary equipment.

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European Pharmaceutical Review

JANUARY 23, 2023

Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.

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Express Pharma

MAY 9, 2023

Whereas proper disposal of unused medications, as well as initiatives to reduce packaging waste, chemical waste, and improve recycling programmes, will aid in pro-actively addressing this challenge. This may involve the use of eco-friendly raw materials, green manufacturing processes, and eco-friendly packaging.

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FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. Here are some resources that can provide you with the best information on OTC drugs. Link National Institutes of Health (NIH) The NIH is a part of the U.S.

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LifeProNow

MARCH 10, 2023

million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. ASBM and its member organizations intend to submit comments opposing this move and emphasizing the value this information provides to patients and physicians. However, S.6 ASBM surveys of U.S.

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GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials.

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Express Pharma

JUNE 2, 2023

As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market.

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Pharma Packaging Solutions

JUNE 30, 2023

As biopharma technology progresses, becoming both more prevalent and available, the need for high-quality biopharma packaging increases. We offer a variety of packaging services, including vial and ampule labeling, pharmaceutical kit assembly, and more. appeared first on Pharma Packaging Solutions.

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Pharma in Brief

AUGUST 9, 2021

Finally, RMPs would not be considered confidential business information – summary information on each new RMP would be published by the Minister. The amendments contemplate labelling flexibilities for special containers. Rolling Submissions. On-site Evaluations.

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Pharma Marketing Network

AUGUST 9, 2023

Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Ensure that all marketing materials, including advertisements, websites, and social media content, provide clear and accurate information about your products. Keep thorough records of approvals for future reference.

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Pharma Packaging Solutions

SEPTEMBER 26, 2019

We have plenty of new things to talk about including sustainable packaging – this seems to be a hot topic and we are your sustainability packaging partner. Of course, if you need blister packaging or bottling or vial labeling, we can discuss that too. appeared first on Pharma Packaging Solutions.

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GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. What are the examples of cross contamination in pharmaceutical industry?

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