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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Development Production Drugs FDA Approval 140

Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

Marketing 173

Marketing Sales Manufacturing Drugs 173

Pharmacy Checkers

MAY 22, 2020

has proved itself to be too dependent on drug imports from China. Although I for one can’t stand China-bashing or any unnecessary nationalistic rhetoric, that doesn’t mean we should be as reliant as we are on China for critical products such as life-saving pharmaceuticals. The Januvia package reads “Formulated in UK.”

Manufacturing 98

Manufacturing Drugs Generic Drugs Branding 98

FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

Marketing 130

Marketing Sales Manufacturing Drugs 130

FDA Law Blog

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). 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. §

Generic Drugs 40

Generic Drugs Production Drugs Manufacturing 40

Pharmacy Checkers

FEBRUARY 14, 2020

In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. So, the Graedons spoke up!

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Branding FDA Approval Pharmacy Bioequivalency 62

Pharmacy Checkers

JANUARY 10, 2020

For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing , which is a serious problem. FDA: PIERRE FABRE MEDICAMENT PRODUCTION.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

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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Insulin Manufacturing Contract Manufacturing Production 328

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.

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Regulation Drugs Manufacturing Production 98

Pharma in Brief

JANUARY 9, 2022

The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.

Regulation 52

Regulation Manufacturing Drugs Medicine 52

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. What Are Generic Drugs?

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89

Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. With new generic drugs entering the market every year, it can be challenging to stand out from the crowd and achieve success.

Generic Drugs 52

Generic Drugs Marketing Drugs Compliance 52

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Clearly, the FDA acknowledges the relative strength of the EU on drug safety. and the EU are very similar.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

XTalks

JANUARY 23, 2025

In its second interim staff report released January 14, 2025, the Federal Trade Commission (FTC) revealed that the top three pharma benefit managers (PBM) in the US inflated prices of specialty generic drugs over the past several years, resulting in them raking in billions of dollars in profits. billion in 2021.

Drugs 59

Drugs Generic Drugs Pharmacy Insulin 59

Pharmacy Checkers

JUNE 21, 2019

Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. prescription drugs. wholesalers.

Pharmacy 61

Pharmacy Drugs Branding Medicine 61

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Production Manufacturing Drugs Generic Drugs 263

Pharmacy Checkers

OCTOBER 11, 2019

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public. The discussion below applies to brand-name (not generic) drugs. Drug companies make their products in many countries and ship those same drugs around the world to different markets.

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FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

MARCH 11, 2020

The standard required to permit lawful wholesale importation, part (b)-(h) from Canada is that it “ pose no additional risk to the public’s health and safety and would be expected to result in a significant reduction in the cost of covered products to the American consumer.”. Postal Service for packages coming through IMFs. [16].

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

FDA Law Blog

SEPTEMBER 13, 2021

Readers following drug pricing activity will recognize several strategies already associated with Senate Democrats (e.g., Medicare negotiation authority; encourage biosimilars and generic drug utilization). The HHS plan’s proposals are defined in general terms, without estimates of taxpayer savings or timelines.

Drugs 98

Drugs Manufacturing Generic Drugs Branding 98

XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

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Vaccine Vaccination Antibody Life Science 92