Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT.

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XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. These chemicals help prevent grease and oil from seeping through the packaging. Why PFAS in Food Packaging Is a Problem. What the Report Found.

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XTalks

JULY 27, 2023

Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging?

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XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. The levetiracetam injection (USP 500 mg per 5 mL) is packaged in a single-dose 5 mL vial. The integrity of container closures is critical to drug safety.

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Drugs Packaging Packaging Containment 105

Outsourcing Pharma

JANUARY 30, 2024

Two new offerings have been unveiled by drug delivery and solutions provider, Stevanto Group S.p.A.

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Roots Analysis

FEBRUARY 28, 2022

Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences.

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Pharma Mirror

NOVEMBER 4, 2022

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers.

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Roots Analysis

APRIL 21, 2022

Sustainable packaging is defined as packaging that is safe for individuals, as well as the environment, while meeting all requirements for performance, cost and ease of fabrication. The continuously growing pipeline of pharmaceutical drug candidates has inadvertently led to an increase in the demand for product packaging solutions.

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Roots Analysis

FEBRUARY 16, 2022

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1] Our Social Media Platform.

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Camargo

OCTOBER 14, 2021

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

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Packaging Packaging Compliance Manufacturing 130

Pharma Packaging Solutions

NOVEMBER 14, 2024

Packaging plays a critical role in the pharmaceutical industry, ensuring that medications remain safe, effective, and stable throughout their shelf life. At Tjoapack, we are your trusted provider of pharmaceutical packaging services , dedicated to maintaining the integrity and efficacy of your products from production to patient use.

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Packaging Packaging Contamination Pharma Packaging 52

Roots Analysis

APRIL 20, 2022

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. In addition, over the next five years, the global pharmaceutical market is projected to grow at a CAGR of 4.7%, with global drug sales anticipated to raise revenues worth USD 1.5 trillion in 2023.

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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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Drugs Packaging Packaging Production 100

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.

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XTalks

JANUARY 24, 2022

Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. While Biktarvy brought in $7.3

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Pharma Tutor

OCTOBER 2, 2020

Among those critical steps, one step is performing sampling of different materials such as starting materials, packaging materials, in-process materials, finished product. The review focused on sampling procedure used for the above mentioned materials and sampling tools used for performing sampling activities in pharmaceutical industries.

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Packaging Packaging Production Containment 98

Roots Analysis

AUGUST 14, 2024

Packaging is the process of enclosing a product in a container in order to protect and store it. In the pharmaceutical industry, packaging plays a crucial role in ensuring the strength and integrity of a product. Further, the type of raw material utilized for packaging highly depends on the type of product / drug to be enclosed.

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XTalks

JULY 26, 2024

These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.

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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

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Packaging Packaging Production Manufacturing 40

Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.

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FDA Law Blog

NOVEMBER 7, 2022

Kirschenbaum — On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. The only differences relate to timing.

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Drugs Packaging Packaging Containment 59

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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Pharmaceutical Technology

FEBRUARY 7, 2023

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. One general trend throughout Europe is the use of cost-containment measures to control public spending.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

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FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

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Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC. Validation Code.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies. Packaging. • It may provide access to discontinued drugs and allows for alternative compounded dosage forms. Excipients. Formulation.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics. What is driving the biologics API manufacturing services industry.

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XTalks

JULY 27, 2022

Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility.

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Pharmaceutical Technology

MARCH 10, 2023

Lebanon’s P&R system In Lebanon, drug prices are reviewed and determined by the Ministry of Public Health (MoPH) during the registration process. International reference pricing applies to all originator medicines and serves as the main mechanism for pricing in-patent and off-patent originator drugs.

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Marketing Branding Medicine Manufacturing 130

XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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Druggist

JANUARY 9, 2021

Migraine management with drugs in broadly divided into prophylactic treatment (to prevent migraines) and acute treatment for managing migraine-associated headaches and nausea. This post will focus on the acute management of migraines with drugs, which can be purchased over the pharmacy counter. Paracetamol.

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