Pharmaceutical Technology

DECEMBER 7, 2023

Sterile filling is a critical step in pharmaceutical primary packaging. However, during this process, some drug product loss is inevitable.

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Drug Patent Watch

JANUARY 22, 2025

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. But what exactly does GMP entail? Share your thoughts in the comments below!

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Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

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Pharmaceutical Technology

NOVEMBER 15, 2022

Manufacturers are actively looking at ways they can improve drug delivery through well-designed parenteral packaging systems, and the choice to deploy prefilled syringes for more and more injectable drug products is a key part of this push. However, they are not always a first choice. Lowering extractables levels .

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pharmaphorum

DECEMBER 22, 2022

Four Japanese drugmakers – Astellas, Eisai, Daiichi Sankyo, and Takeda – have joined forces in a partnership intended to reduce the environmental impact of pharmaceutical packaging. It started using the sugarcane in its irritable bowel syndrome (IBS) drug Irribow (ramosetron), sold in Japan.

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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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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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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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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. extractables and leachables).

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 12, 2023

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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Pharmaceutical Technology

SEPTEMBER 4, 2024

Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

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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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Outsourcing Pharma

JULY 12, 2024

Blow-fill-seal (BFS) technology has long been a cornerstone of pharmaceutical manufacturing, relied on for packaging sterile liquid medications, including but not limited to ophthalmic and respiratory drug products.

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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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Pharmaceutical Technology

SEPTEMBER 23, 2022

These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones. Narrower Product Focus Emphasis on Development End-to-End Support and Manufacturing Flexibility Manufactured in the USA Continuous Reinvestment. Narrower product focus.

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Pharmaceutical Technology

DECEMBER 12, 2022

Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturing organizations (CMOs). Iomab-B met the durable complete remission endpoint.

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Pharmaceutical Technology

JULY 15, 2022

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

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Camargo

OCTOBER 20, 2021

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Such products require more complex target profiling. Definition of Combination Products. FDA Oversight for Combination Products.

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XTalks

NOVEMBER 27, 2024

The initiative aims to bolster the production of Thymoglobulin (antithymocyte globulin [rabbit]), a treatment for kidney transplant rejection, and to localize the manufacturing of type 1 diabetes therapy Tzield (teplizumab). million) will be dedicated to the production and development of a second-generation Thymoglobulin.

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Pharmaceutical Technology

JULY 25, 2022

The drug developers will use artificial intelligence based on the acquired data from these devices and from the healthcare providers, allowing them to create and provide personalized treatments maybe even in predictive ways later on,” he explains.

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Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The FDA governs the drug and biologic approval process in the United States, while the EMA serves the European Union (EU) plus Iceland, Norway, and Liechtenstein.

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Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Why do large and mega-cap sponsors outsource?

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Pharma Packaging Solutions

SEPTEMBER 8, 2022

It’s extremely essential to protect pharmaceutical products from damage during shipping and distribution, as faulty medication could have disastrous consequences for consumers. That’s why the drug packaging process is so important, and must be carried out correctly.

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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. Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Sagent Pharmaceuticals Inc.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. GlobalData is the parent company of Pharmaceutical Technology. Regulatory decisions come in.

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Pharmaceutical Technology

NOVEMBER 7, 2022

SHL Medical is a world-leading solutions provider for advanced drug delivery systems with a unified purpose to further enable patient independence. The company’s most prominent products are its autoinjectors, which are seeing growing global demand. It will be high-tech, fully automated production,” Turvill adds. “A

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XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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World of DTC Marketing

MARCH 9, 2021

Pharma has an opportunity to engage customers and caregivers via email but they can’t send out product flyers. In our test a magazine type email, with general as well as product information, did best as compared to a one-page product information email. In other words, one email campaign doesn’t fit all.

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Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

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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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Pharmaceutical Technology

APRIL 3, 2023

The regulatory approval comes after a positive opinion was issued by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) in January this year. The company conducted a Phase I pharmacokinetics (PK) bridging trial as part of the comprehensive submission package to the EMA.

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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). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. These meetings will be held to help drug developers prepare for their MAAs through an assessment of development plans amongst other things.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Covid-19 vaccines stay in the spotlight.

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Drug Patent Watch

MARCH 19, 2025

Navigating the Complex World of Drug Patents: A Comprehensive Strategy is Key As a pharmaceutical professional, you know that developing new medications is a costly and time-consuming process. But what happens when your product's patent is about to expire, or you're facing competition from generic manufacturers? But where do you start?

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XTalks

FEBRUARY 25, 2025

A recent survey by 9amHealth has revealed a significant trend in employee health benefits: employer-sponsored GLP-1 drug coverage is emerging as a pivotal factor in attracting and retaining top talent. Many job seekers are thus factoring the availability of GLP-1 drug coverage into their decisions about where to work.

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