Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. Regulatory System on Generic Drugs in Japan.

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Drug Patent Watch

MARCH 18, 2025

This is where generic drug development comes in a game-changer for millions of people around the world. The Power of Generic Medications Generic medications have been a cornerstone of affordable healthcare for decades.

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Drug Patent Watch

JANUARY 21, 2025

Navigating the Complex World of Generic Drug Development: Risk Management Strategies to Know As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. One of the biggest risks generic drug developers face is patent infringement.

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Drug Patent Watch

MARCH 17, 2025

Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? Or perhaps you're a healthcare professional interested in understanding the intricacies of generic drug launches? Have you had success with a recent launch?

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Drug Patent Watch

OCTOBER 12, 2021

International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

OCTOBER 10, 2024

China has emerged as a significant player in the global generic drug active pharmaceutical ingredient (API) market. The country’s vast production capacity, low costs, and strategic location have made it an attractive destination for pharmaceutical companies seeking to source APIs.

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Drug Patent Watch

OCTOBER 14, 2024

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Patent Watch

AUGUST 27, 2024

These innovations aim to enhance drug quality, efficiency, and customization. Despite their potential, the adoption of AMTs in generic drug manufacturing has been slow, mainly due to high upfront investment costs and regulatory barriers.

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Drug Patent Watch

SEPTEMBER 24, 2024

The development of generic drugs has become increasingly complex, requiring advanced analytical technologies to ensure the quality and efficacy of these products. This article will explore the latest developments in… Source

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy.

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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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NY Times

SEPTEMBER 18, 2021

Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

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The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. Most of these, or 918 (59%) were for non-complex formulations while 640 (41%) were for complex products, Zhang said. © 2021 Regulatory Affairs Professionals Society.

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World of DTC Marketing

APRIL 12, 2021

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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Pharmaceutical Technology

JULY 25, 2022

But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds. Broadly, complex drugs are treatments with complicated active pharmaceutical ingredients (APIs), formulations, or drug/device combinations.

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Drug Patent Watch

JUNE 18, 2024

Branded generics are generic drugs that are marketed under a brand name by the manufacturer. These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point.

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Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023). ©GlobalData.

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. Misconceptions about the efficacy and safety of biosimilars can lead to hesitancy in prescribing or using these products.

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Pharmaceutical Technology

AUGUST 12, 2022

And while the gloomiest predictions around medicine shortages do not appear to have come to pass, shortfalls in drugs like HRT products have been partially attributed to Brexit. Because the products would already have been tested within the exporting country, the testing would be duplicative and (to many people’s minds) unnecessary.

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Pharmaceutical Technology

OCTOBER 5, 2008

’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi. ” The move, which came in June, also gives Japanese drugs maker Daiichi Sankyo a foothold in the Indian market through Ranbaxy’s location. .”

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FDA Law Blog

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Drug Patent Watch

DECEMBER 9, 2024

For example, the anti-malarial drug artemisinin was discovered by Chinese scientist Tu Youyou, who was inspired by ancient Chinese medical texts. High-Throughput Screening: Modern Technology Meets Natural Products Advanced technologies now allow researchers to rapidly test thousands of natural compounds against specific disease targets.

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World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Medicare drug insurance is a product of compromise after decades of debate in Congress. Generic drugs may also be cheaper with a coupon than your drug insurance. The result:?

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.

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Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. Below, we share our estimates for wholesalers’ gross margins for brand-name, generic, and biosimilar drugs. drug distribution.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Camargo

OCTOBER 14, 2021

The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.

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Camargo

DECEMBER 9, 2020

Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs. Prescription refill and generic drug programmes. Proprietary pharmaceutical, nutraceutical, and cosmeceutical products. Speciality care. Compounding services. Pharmacogenetics testing.

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Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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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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FDA Law Blog

NOVEMBER 16, 2021

That section of the bill – along with the other accompanying sections and parts of the bill – would amend Title XI of the Social Security Act to create a new part – Part E – requiring the HHS Secretary to establish a “Fair Price Negotiation Program” intended to lower prices for certain high-priced single-source drugs and biological products.

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