Pharmaceutical Technology

SEPTEMBER 23, 2022

Avéma, for example, specialises in small molecule, oral solid, and liquid dose drugs. generic drugs at both small development companies and multinational pharmaceutical companies. Avéma has also expanded its liquid manufacturing capabilities and added full on-site serialisation capabilities to its packaging lines.

Manufacturing 147

Manufacturing Drugs Production Development 147

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. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 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

Pharmacy Checkers

MAY 22, 2020

The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) the drug company that makes Janumet and Januvia) gets its sitagliptin from Italy to make Januvia, and it probably uses that same API to make Janumet. But Metformin is an off patent, widely-manufactured generic drug.

Manufacturing 98

Manufacturing Drugs Generic Drugs Branding 98

Camargo

DECEMBER 9, 2020

The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. In stark contrast, meetings for ANDAs with the Generic Drug Division have been few and far between, inconsistently granted, and, if held, poorly documented. GDUFA has changed this picture, at least for complex drug products.

Development 140

Development Production Drugs FDA Approval 140

Pharma in Brief

AUGUST 9, 2021

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. On-site Evaluations.

Regulation 98

Regulation Drugs Manufacturing Production 98

FDA Law Blog

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. § 355(j)(2)(A)(v).

Generic Drugs 40

Generic Drugs Production Drugs Manufacturing 40

The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

Pharmacy Checkers

FEBRUARY 14, 2020

Retail Price from GoodRX | *As the Canadian-based pharmacies only offer quantities in 90 or 180 tablet packages, this price was calculated based on the 90-day supply price. Prices collected February 2020 for quantity of 30 tablets | Average U.S. Below are U.S. pharmacy labels of Wellbutrin XL 150mg and 300mg.

Branding 62

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 Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

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.” counterpart, the Drug Supply Chain Security Act (DSCSA) doesn’t come into full force until 2023.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

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 Andrew Witty, its CEO, had a 2021 pay package worth $18.4 Generic drugs may also be cheaper with a coupon than your drug insurance. Prior authorization is out of control. The result:?

Doctors 263

Doctors Doctor Generic Drugs Drugs 263

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.

Production 263

Production Manufacturing Drugs Generic Drugs 263

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.

Pharmacy 61

Pharmacy Drugs Branding Medicine 61

STAT News

MARCH 7, 2023

 The plan would give the administration authority to negotiate what price the federal government pays for more drugs than the limited number approved as part of Democrats’ legislative package last year, while also speeding up the process for negotiations. Continue to STAT+ to read the full story…

Drugs 98

Drugs Generic Drugs Marketing Packaging 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

World of DTC Marketing

APRIL 12, 2021

Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors. Can patients really be confident in pharma supply chains?

Generic Drugs 187

Generic Drugs Manufacturing Drugs Production 187

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 77

Generic Drugs Drugs Branding Bioequivalency 77

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

Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

Generic Drugs 52

Generic Drugs Bioequivalency Drugs Branding 52

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 billion in 2022.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. In some cases, previously routine postings are delayed or going unpublished altogether.

Packaging 59

Packaging Packaging Generic Drugs Life Science 59

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

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.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

MARCH 11, 2020

Postal Service for packages coming through IMFs. [16]. That AED lets the USPS know the source of a package. Thus, for example, the path of a drug from a licensed pharmacy in Canada to a patient in the U.S. Personal Drug Importation Related to the Internet. could be guaranteed using AED.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

FDA Law Blog

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

Generic Drugs 64

Generic Drugs Packaging Packaging Drugs 64

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.

Vaccine 92

Vaccine Vaccination Antibody Life Science 92