Pharmaceutical Technology

JUNE 24, 2025

Robert Barrie June 24, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Compounded GLP-1RA medication has become a key revenue driver for Hims & Hers’ telehealth platform. Hims & Hers’ revenue has been soaring on the back of its compounded glucagon-like peptide-1 receptor agonist (GLP-1RA) sales.

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BuzzRx

OCTOBER 14, 2022

If your doctor’s office has given you a prescription with instructions to fill it at a compounding pharmacy, you might be wondering what exactly this means. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding. What does it mean when a pharmacy is compounding?

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Pharmaceutical Technology

FEBRUARY 23, 2023

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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PharmTech

JUNE 10, 2025

Regulatory and Policy Implications Key Takeaways ·ACIP overhaul disrupts vaccine approval timelines, posing risks to clinical trial planning, FDA readiness, and seasonal launch strategies. The news follows announcements in March of a restructuring to include the reduction of HHS workforce by 10,000 full-time employees.

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The Checkup by Singlecare

MARCH 21, 2024

Its active ingredient, semaglutide, is FDA approved for weight loss under the brand name Wegovy , which has a dosing progression of 0.25 Food and Drug Administration (FDA) may allow it for people with prescriptions who are purchasing a drug that’s already approved in the United States. mg, 1 mg, 1.7 mg, and 2.4

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Pharmaceutical Technology

JUNE 12, 2025

Novo Nordisk is eyeing a cardiometabolic drug market future that is not purely dominated by incretins, after signing a $812m partnership with Deep Apple Therapeutics to access novel compounds for obesity and other diseases. Give your business an edge with our leading industry insights.

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The Checkup by Singlecare

DECEMBER 2, 2024

Your Zyrtec will expire, and the Food and Drug Administration (FDA) requires the manufacturer to include the expiration date on the product. Drugs are chemical compounds that can break down over time, and the FDA wants to ensure that consumers are taking safe and effective medication. Knowing more can help you better prepare.

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Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

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The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Samples often come in a package of four 2.5 Look into compounded options (but be careful). And it’s not just hype. Shop around.

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The Checkup by Singlecare

FEBRUARY 16, 2023

This class of compounds is derived from vitamin A and is a well-studied group in skin care and skin conditions. Tretinoin is approved by the Food & Drug Administration (FDA) to treat acne and prevent wrinkles, dark spots, and skin roughness from worsening. What is tretinoin and what is it used for?

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The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store. This allows more of its beneficial compounds to reach the gut, where it can correct gut bacteria imbalances.

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Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs.

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The Checkup by Singlecare

DECEMBER 1, 2023

For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. Lower blood sugar and weight loss can lead to better health and wellness outcomes for people with diabetes, who are at a higher risk for heart disease, stroke, kidney failure, and vision loss.

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PharmTech

JUNE 23, 2025

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com Performing calculations for the formulation of pharmaceutical dosage forms and related preparations is a key activity in compounding. Calculating the active moiety amount for compounding follows. Pluta Nishant B. The medication order identifies the active moiety.

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The Checkup by Singlecare

SEPTEMBER 28, 2023

Follow these steps to try nasal irrigation for congestion: Prepare the nasal rinse solution by mixing saline with distilled water per the package instructions. Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory.

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Pharmaceutical Technology

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. The pilot scheme for this has been observed by the FDA and EU Commission.

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Pharmaceutical Technology

JUNE 12, 2025

All pharma shipments must meet strict regulatory requirements that vary significantly between countries, for example Good Manufacturing Practice (GMP) guidelines, which are enforced by entities such as the FDA in the US. Tariffs and trade disputes are further compounding this challenge, affecting the cost structure of pharma businesses.

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pharmaphorum

AUGUST 25, 2021

It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. When the news was getting out from China, our virologists in San Francisco were already scanning compounds, seeing which ones were the most effective.

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Roots Analysis

AUGUST 1, 2024

Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA. per package in the US. According to Novo Nordisk , the list price of Wegovy for patients who do not have any insurance is $1349.02

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ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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The Checkup by Singlecare

APRIL 19, 2024

Food and Drug Administration (FDA)for use in dogs —the canine version is called Reconcile—but its use in cats is off-label. For fluoxetine oral solution, follow the storage and disposal instructions included in the package or specified by the veterinarian or pharmacist. Fluoxetine is approved by the U.S.

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ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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Viseven

AUGUST 15, 2024

For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. Engagement can lead to improvements in drug delivery methods, packaging designs, and support services that enhance the overall patient experience.

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? Does insurance cover Ozempic?

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ISPE

JANUARY 11, 2023

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. [link] The ideal case is a site using one cleaning procedure with an acceptable set of critical cleaning parameters (CCPs) for all products.

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Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

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Pharmacy Times

JUNE 11, 2025

FDA approves tablet formulation of BeOne's BRUKINSA for all approved indications. Package insert. Coverage of this story is ongoing. 1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. 1 REFERENCES 1.

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European Pharmaceutical Review

MARCH 11, 2024

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

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European Pharmaceutical Review

DECEMBER 13, 2022

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. 5 Both compounds are limited to ≤0.1

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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The Checkup by Singlecare

OCTOBER 26, 2023

According to Dr. Kaminetsky, fenugreek contains plant-based compounds called saponins that may cause an increase in testosterone production , though you would likely have to take between 500 and 600 milligrams per day. Food and Drug Administration ( FDA ), so you may be taking a risk when you choose to add one to your diet.

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ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Burke, PhD. 1 September 2022.

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pharmaphorum

SEPTEMBER 21, 2021

“The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs,” said Pam Cheng, AZ’s executive vice president of global operations and IT.

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The Happy PharmD

JANUARY 13, 2025

The FDA recently uncovered thousands of counterfeit Ozempic pens in legitimate pharmacies across the U.S., There are three main types of fake Ozempic making the rounds: complete counterfeits, relabeled insulin pens, and sketchy compounded versions. First, check the packaging. Heres how you can spot these counterfeits.

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European Pharmaceutical Review

FEBRUARY 14, 2024

The first drug products to achieve biological licence approval (BLA) from the US Food and Drug Administration (FDA) are whole community products derived from human faecal matter and are indicted for Clostridium difficile infection.

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