Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Please check your email to download the Webinar. Free Webinar.

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Impact Pharmaceutical Services

AUGUST 9, 2022

Download a PDF of this case study. Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. The Journey Leading to an Approved NDA. 5 clinical study reports. 5 clinical study reports.

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Pharmaceutical Technology

NOVEMBER 25, 2022

A dedicated team-based approach to project management from formulation and development through manufacturing, analytical, packaging, and regulatory review can also streamline PDF production. To find out more, download the whitepaper below. Faster to market.

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Pharmacy Friday Pearls

SEPTEMBER 23, 2022

Download PDF. Four factor prothrombin complex concentrate (4F-PCC) is FDA approved to reverse vitamin K antagonists (VKAs) such as warfarin in adult patients with acute major bleeding or a need for an urgent surgery/invasive procedure. Dosing According to Package Insert. Introduction. Pre-treatment INR 2 – 3.9 References.

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Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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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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Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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European Pharmaceutical Review

NOVEMBER 4, 2022

Based on these results, Athenex filed for a new drug application (NDA) with the US Food and Drug Administration (FDA), but in early 2021 the company received a Complete Response Letter from FDA, citing various concerns including an “increase in neutropenia-related sequelae” in the Oraxol arm. Patient Preference and Adherence, 2016.

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pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. Secondary packagers.

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Pharmaceutical Technology

APRIL 21, 2023

On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

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Pharmacy Friday Pearls

MARCH 9, 2022

Download PDF. It is important to note that at present, Anavip ® is only FDA approved for North American rattlesnake envenomations, even though it is expected that it is safe and effective to use for copperhead and water moccasin envenomations as well. Crofab ® [package insert]. Anavip ® [package insert]. Introduction .

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). www.fda.gov/media/162157/download 7 Okwudire, C. Discussion paper. October 2022.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), They’re great for injuries, overuse, or soreness from workouts.

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European Pharmaceutical Review

OCTOBER 3, 2024

Preparing for the impact of EU GMP Annex 1 on primary packaging Niamh Bissett and Dr Ana Kuschel West Pharmaceutical Services, Inc. Login or create an account to download your copy of our Issue now! The post <em>European Pharmaceutical Review </em> Issue 4 2024 appeared first on European Pharmaceutical Review.

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The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. You can download their mobile app from the apps store on your mobile phone. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating.

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Pharmacy Friday Pearls

MARCH 4, 2022

Download PDF. Retrieved January 17, 2021, from [link] Nirmatrelvir & ritonavir (Paxlovid ) [package insert]. link] Molnupiravir [package insert]. Author: Alyssa Lear, PharmD. Introduction. References. Micromedex [Electronic version].Greenwood Greenwood Village, CO: Truven Health Analytics. New York, NY: Pfizer Inc.;

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