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The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. But what exactly does GMP entail?
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.
International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.
In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.
Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.
Four Japanese drugmakers – Astellas, Eisai, Daiichi Sankyo, and Takeda – have joined forces in a partnership intended to reduce the environmental impact of pharmaceutical packaging. The post Japanese drugmakers make greener packaging pledge appeared first on.
However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.
In recent years, the food industry has faced growing scrutiny over its environmental impact, particularly concerning the use of plastic packaging. This scrutiny has sparked significant interest and investment in alternative packaging solutions, with edible food packaging emerging as a particularly innovative and sustainable option.
But food packaging can play a major role in preserving the life of some food products, with many packagingmanufacturers helping to address this issue. However, food packaging presents challenges of its own in terms of ease of recyclability and waste creation. Constantia Flexibles.
For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.
Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. One of the major challenges for pharmaceutical executives is to manage the leveraging manufacturing and packaging processes.
Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).
Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Consequential FDA and EMA decisions.
Chobani has been exploring and discovering new ways to package its products in a more sustainable and eco-friendly way. Chobani is committed to showing the rest of the world more sustainable packaging as time goes on. Other companies around the globe are also rethinking their packaging to become 100 percent recyclable and reusable.
Blow-fill-seal (BFS) technology has long been a cornerstone of pharmaceutical manufacturing, relied on for packaging sterile liquid medications, including but not limited to ophthalmic and respiratory drug products.
The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. These chemicals help prevent grease and oil from seeping through the packaging. Why PFAS in Food Packaging Is a Problem. Yet PFAS are finding their way into our bodies.
According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.
As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. While food and beverage manufacturers have used the labels for decades to estimate peak freshness, consumers are confused about date codes, often causing more food waste than necessary.
The British pound fell to its lowest level ever against the dollar on September 26, 2022, in reaction to the former UK chancellor Kwasi Kwarteng’s £45bn tax-cutting package, when one dollar equated to £0.92. Exchange rate trends cause trouble for US manufacturers that export.
Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.
The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.
AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.
Few details were available, but eye witnesses said a robot was investigating a suspicious package found at the plant. Police have sealed off the area, according to the report.
While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.
Based on the science from the researchers who established the framework of modern Paleolithic nutrition, the program aims to provide guidance for the food industry by codifying Paleo Diet standards and making them available to manufacturers, retailers and other partners. billion by 2027, growing at a compound annual growth rate (CAGR) of 3.6
In the complex world of pharmaceutical packaging, selecting the right blister packaging supplier is a critical decision that can significantly impact product presentation, protection, and compliance. At Tjoapack, we are a leading provider of blister packaging solutions designed to meet the unique needs of the pharmaceutical industry.
Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).
Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations. Find the leading pharmaceutical solid dose manufacturing companies in contract marketing. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.
From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.
PDF scale and reformulation challenge manufacturers. In many cases, pharma companies select a contract development and manufacturing organisation (CDMO) to develop products versus doing the work themselves for reasons related to cost, convenience, and capacity. Innovative solutions to complex challenges.
The online marketplace PartnerSlate has made waves in the food and beverage contract manufacturing industry, recently securing a $4 million investment to further its mission of connecting food brands and contract manufacturers. This is where San Francisco-based PartnerSlate comes in.
XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with an AI-Powered eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST ( 4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.
To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The vaccine doses are intended for countries outside the US, with manufacturing planned to commence in the third quarter of 2021.
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