PharmaTech

JULY 19, 2022

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.

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Celeritas

OCTOBER 14, 2022

Stakeholder Mapping involves identifying professionals in the target therapeutic field who would utilize or influence the utilization of the pharmaceutical product. Contacting stakeholders can be key to knowing where they stand upon the release of the pharmaceutical product. What is a Stakeholder Map?

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eMediWrite

OCTOBER 3, 2022

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.

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Pharmaceutical Commerce

NOVEMBER 8, 2024

One packaging aspect—the tape—is often overlooked, but is a valuable component of the shipping process.

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Pharmaceutical Commerce

APRIL 5, 2024

In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.

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eMediWrite

JULY 13, 2023

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.

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Source Explorer

APRIL 9, 2020

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PharmaTech

MAY 8, 2024

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends.

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MedCity News

MARCH 18, 2024

Generic drugs are the pharmaceutical products 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.

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World of DTC Marketing

MARCH 10, 2022

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 pharmaceutical product and they will do anything to keep that money. Sales of Humira earned AbbVie $20.7

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PharmaTech

JANUARY 11, 2024

Webinar Date/Time: Wed, Feb 7, 2024 10:30 AM CET (4:30 AM EST)

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MedCity News

JUNE 20, 2022

In other drug decision news, the Rhythm Pharmaceuticals product 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.

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MedCity News

JUNE 29, 2023

The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder. The FDA approved Roctavian for treating hemophilia A.

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European Pharmaceutical Review

JANUARY 2, 2024

highlighted that “in the EU market, a relatively low number of approved pharmaceutical products adopted the QbD methodology or describe QbD elements in their regulatory submissions.” For example, Simões et al. The team examined the European Public Assessment Report (EPAR) for the QbD approach.

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European Pharmaceutical Review

JULY 5, 2023

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 pharmaceutical product packaging.

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Pharmaceutical Technology

JUNE 7, 2023

Shanghai Fosun Pharmaceutical (Group) is to collaborate with the International Finance Corporation (IFC) to construct a new pharmaceutical production facility and distribution hub near Abidjan, Côte d’Ivoire. The IFC will provide two loans totalling $53.49m (€50m) to Fosun Pharma’s subsidiaries.

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European Pharmaceutical Review

AUGUST 25, 2022

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.

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PharmaTech

SEPTEMBER 11, 2024

Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products. During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R.

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MedCity News

AUGUST 7, 2023

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

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European Pharmaceutical Review

FEBRUARY 22, 2023

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 pharmaceutical products, as well as the hurdles that must be navigated to realise its potential.

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European Pharmaceutical Review

APRIL 13, 2023

From development to distribution, INTERPHEX is the leading global event that takes you through all stages of the pharmaceutical product development lifecycle. Read the full press release here >> Innovatech Gateway Pavilion is the portal to global pharmaceutical technologies.

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European Pharmaceutical Review

AUGUST 9, 2022

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 pharmaceutical product recalls and accounted for 45.3

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European Pharmaceutical Review

JULY 10, 2023

Traditional methods for assessing microbial contamination in pharmaceutical products 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.

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European Pharmaceutical Review

APRIL 15, 2024

However, they noted that air and surface microbial levels “may vary” according to the sampling conditions and the pharmaceutical production environments. Higher microorganism levels were obtained in the air sampling, compared to the surface sampling, stated Soares et al.

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European Pharmaceutical Review

AUGUST 23, 2022

1 Simply, pharmaceutical products 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

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European Pharmaceutical Review

APRIL 30, 2024

The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceutical products. For setting AI limits, WHO noted “expectations when a nitrosamine impurity cannot be synthesised or isolated and purified” should be considered.

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Pharma Pathway

DECEMBER 13, 2022

Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceutical products, pharmaceutical substances and Intermediates.

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Pharmaceutical Technology

JUNE 12, 2023

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 pharmaceutical products, orphan drugs and other life-saving medicines.

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European Pharmaceutical Review

JULY 10, 2023

Fungal contamination in pharmaceutical products 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.

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European Pharmaceutical Review

NOVEMBER 24, 2022

The number of unauthorised and unregulated online outlets selling counterfeit pharmaceutical products 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.

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European Pharmaceutical Review

OCTOBER 24, 2023

Packaging materials As an “integral part of the pharmaceutical product”, 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

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Pharma Pathway

DECEMBER 3, 2022

Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceutical products, pharmaceutical substances and Intermediates. Department: EHS/ Engineering.

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European Pharmaceutical Review

APRIL 26, 2024

Use of disposable and pre-filled syringes means this equipment can be prepared and filled as per good manufacturing practice (GMP) requirements in pharmaceutical production facilities, the authors wrote. This is notable, because according to Rodríguez-Pombo et al., treatment adherence can be an issue for certain patients.

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Pharmaceutical Commerce

APRIL 29, 2024

The CDMO’s boost in production will be centered around pharmaceutical products.

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PharmaTech

AUGUST 5, 2024

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

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Pharmaceutical Technology

JULY 3, 2024

Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.

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European Pharmaceutical Review

DECEMBER 22, 2022

The use of vibrational spectroscopy, including raman mapping, to study pharmaceutical products has been widely applied across the industry for several decades. These techniques can be utilised to understand polymorphs, intra- and inter-molecular interactions and solid form changes within pharmaceutical products.

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