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The post Microbial burden assessment of solid pharmaceuticalproducts appeared first on European Pharmaceutical Review. cepacia complex and E. coli in tablets and capsules with water activity lower than 0.60”.
The Benefits of a Sales Pilot for PharmaceuticalProducts A sales pilot is a short-term experiment that tests a product’s sales performance or a new sales approach. The post The Benefits of a Sales Pilot for PharmaceuticalProducts appeared first on MaBiCo.
Few pharmaceuticalproducts have taken the market by storm like Roche’s Vabysmo. Interim results from a late-stage trial of Roche's Vabysmo on Asian patients with polypoidal choroidal vasculopathy suggest that the injected treatment is effective.
It usually goes without saying that your pharmaceuticalproduction workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.
Predictive maintenance in pharmaceuticalproduction can help reduce downtime and increase efficiency. Grundfos Machine Health (GMH) uses artificial intelligence (AI)-driven wireless sensors to monitor motor health in real-time, identifying potential issues.
The process of giving a pharmaceuticalproduct a unique identity on the market is called pharmaceuticalproduct positioning. It entails recognising the special qualities and advantages of your product and conveying them to the intended market in a way that sets it apart from rival goods.
Predictive maintenance in pharmaceuticalproduction can help reduce downtime and increase efficiency. Grundfos Machine Health (GMH) uses artificial intelligence (AI)-driven wireless sensors to monitor motor health in real-time, identifying potential issues.
Stakeholder Mapping involves identifying professionals in the target therapeutic field who would utilize or influence the utilization of the pharmaceuticalproduct. Contacting stakeholders can be key to knowing where they stand upon the release of the pharmaceuticalproduct. What is a Stakeholder Map?
Understanding a product’s life cycle can assist a company in determining its position in the market relative to rivals and the success or failure of the product. But certainly, there are some challenges in the process. Technology transfer.
Generic drugs are the pharmaceuticalproducts mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.
Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceuticalproduct that is the only FDA-approved Alzheimers agitation drug. The post Axsome Aims for FDA Filing in Alzheimers Agitation Despite Mixed Bag of Phase 3 Data appeared first on MedCity News.
In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceuticalproducts tend to cost more in the US than the rest of the world.
From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.
The regulatory decision makes the BioMarin Pharmaceuticalproduct the first gene therapy for this inherited bleeding disorder. The FDA approved Roctavian for treating hemophilia A.
market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. billion last year, the highest total for any pharmaceuticalproduct and they will do anything to keep that money. Sales of Humira earned AbbVie $20.7
The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticalsproduct. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.
In other drug decision news, the Rhythm Pharmaceuticalsproduct Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication. AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation.
The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceuticalproduct packaging.
Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceuticalproduction facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.
In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.
Palmer Limited discussed how aging facilities can impact the quality of pharmaceuticalproducts. During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R.
Computed tomography for in-depth investigation of freeze-dried products In this article, Teresa Siegert and Henning Gieseler, discuss the benefits of applying computed tomography in the production of freeze-dried pharmaceuticalproducts, as well as the hurdles that must be navigated to realise its potential.
From development to distribution, INTERPHEX is the leading global event that takes you through all stages of the pharmaceuticalproduct development lifecycle. Read the full press release here >> Innovatech Gateway Pavilion is the portal to global pharmaceutical technologies.
According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceuticalproduct recalls and accounted for 45.3
Traditional methods for assessing microbial contamination in pharmaceuticalproducts can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph.
However, they noted that air and surface microbial levels “may vary” according to the sampling conditions and the pharmaceuticalproduction environments. Higher microorganism levels were obtained in the air sampling, compared to the surface sampling, stated Soares et al.
1 Simply, pharmaceuticalproducts are the most vulnerable to counterfeiting. 2 The global counterfeit pharmaceuticals trade is estimated to be worth billions annually, 3 bolstered significantly by the increased illicit online pharmacies that emerged during the COVID-19 pandemic. This allows for a cyber?physical All protein?based
The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceuticalproducts. For setting AI limits, WHO noted “expectations when a nitrosamine impurity cannot be synthesised or isolated and purified” should be considered.
Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceuticalproducts, pharmaceutical substances and Intermediates.
Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceuticalproducts, orphan drugs and other life-saving medicines.
Fungal contamination in pharmaceuticalproducts represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism.
Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceuticalproducts, pharmaceutical substances and Intermediates. Department: EHS/ Engineering.
Packaging materials As an “integral part of the pharmaceuticalproduct”, the report authors stated that within the packaging segment in this market, in 2022, the primary packaging segment held the highest share of 70.40 This is expected to grow at the highest compound annual growth rate of 5.01
The number of unauthorised and unregulated online outlets selling counterfeit pharmaceuticalproducts is continuously growing, with many selling counterfeit medications via the internet typically posing as legitimate vendors. Counterfeit medicines and medical supplies can also cause significant harm to people, the report said.
Use of disposable and pre-filled syringes means this equipment can be prepared and filled as per good manufacturing practice (GMP) requirements in pharmaceuticalproduction facilities, the authors wrote. This is notable, because according to Rodríguez-Pombo et al., treatment adherence can be an issue for certain patients.
Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceuticalproducts.
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