European Pharmaceutical Review

JANUARY 30, 2024

Ryzneuta (efbemalenograstim alfa) received a positive opinion from the CHMP as a medicine to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. Additionally, a positive opinion for Niapelf (paliperidone), a generic medicine for schizophrenia was adopted in the meeting.

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Pharmaceutical Technology

DECEMBER 15, 2022

The EU has banned the export of crude oil (from December 2022) and refined petroleum products (from February 2023), as well as coal and other solid fossil fuels. Europe also enforces rigid pricing policies for essential medicines to be available at the lowest possible price.

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Generic Medicine Drug Pricing Biosimilars Hospitals 98

Express Pharma

JUNE 12, 2024

In 2023, while the deal volume declined, the deal value grew (1), due to strategic megadeals in the pharma sector. billion in 2023, there is compelling investor interest in medtech and biotech companies. India’s pharmaceutical sector is on a growth trajectory. E.g. Merck, GSK, and Novartis have spun off their consumer groups.

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Generic Medicine Vaccines Diabetes Immunization 105

Drug Patent Watch

DECEMBER 12, 2024

Encouraging Competition : The FDA should work to lift barriers to generic drug competition by addressing scientific and regulatory obstacles. This can help increase the availability of lower-cost, generic medicines and reduce the cost burden on patients and the healthcare system. References Schulman, K. JAMA, 314(14), 14691470.

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Generic Medicine 79

Express Pharma

DECEMBER 7, 2023

India Pharma Inc, hailed for its prowess in the production of high-quality generic medicines, now needs to shift from a conventional, volume-based business strategy to a value-based approach to keep it up its growth momentum. The next one, Vizag Pharma Summit 2023, will be held in Visakhaptanam on May 19, 2023.

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Generic Medicine Documentation 105

Express Pharma

JUNE 21, 2024

In 2023, while the deal volume declined, the deal value grew1, due to strategic megadeals in the pharma sector. billion in 2023, there is compelling investor interest in medtech and biotech companies. India’s pharmaceutical sector is on a growth trajectory. For e.g. Merck, GSK and Novartis have spun off their consumer groups.

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Generic Medicine Vaccines Diabetes Immunization 102

European Pharmaceutical Review

MARCH 14, 2023

The CJEU stressed that identical medicinal products are not those that are only therapeutically equivalent (as generics are to reference products), but they should be identical in all respects.

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Packaging Generic Medicine Labelling Pharmaceutical Companies 98

European Pharmaceutical Review

JULY 25, 2023

percent during the forecast period from 2023 to 2032 is predicted. The small molecule API market is influenced by several factors, including heightened R&D within the pharmaceutical sector, a growing prevalence of chronic illnesses and rising demand for generic medicines. A compound annual growth rate (CAGR) growth of 5.9

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Compounding Generic Medicine Drug Development Diabetes 97

Express Pharma

AUGUST 22, 2023

The report analyses selected companies of varying sizes that manufacture and market antibiotics – including research-based pharma companies, generic medicine manufacturers and business-to-business providers.

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Generic Medicine Hospitals 98

Quality Matters

NOVEMBER 27, 2023

Through its standards, scientific expertise, capability building solutions, unique insights, and work with organizations like Duke-Margolis, USP is working to enable a more resilient medicine supply chain so that people can get their medicines when they need them. Anastasia.Sonn… Mon, 11/27/2023 - 10:45 Supply Chain

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Generic Medicine Hospitals 105

pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. ” Hospira isn’t the only generics company trying to bring a version of regadenoson to the US market.

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Generic Medicine 52

Quality Matters

JUNE 26, 2023

Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. link] (accessed on June 12, 2023) 2 Daan J.A. link] (accessed on June 12, 2023). link] (accessed on June 12, 2023) 7 Regulatory harmonization. Shah, et al.

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Dosage Generic Medicine Labelling 52

Express Pharma

NOVEMBER 15, 2024

Integrating ESG considerations into core pharma operations India, known as the “Pharmacy of the World,” produces over 20 per cent of the global supply of generic medicines and plays a vital role in vaccine production, as per the Investindia.gov.in It meets the healthcare needs of over 1.4

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Packaging Generic Medicine Pharmaceutical Manufacturing Vaccines 102

Quality Matters

JANUARY 23, 2023

USP looks forward to working with all stakeholders on implementation of these important initiatives in 2023. Improved supply chain visibility Longstanding medicines supply chain vulnerabilities – including those that could result in drug shortages – became even more evident during the COVID-19 pandemic.

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Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

Express Pharma

JULY 3, 2023

By empowering process development scientists to generate process quality attribute (PQA) data themselves, we enable them to make decisions about which molecules to advance into pre-clinical development more rapidly. resin consumption), and effectively monitor and manage product quality. How poised are you to leverage them?

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Biosimilars Drug Development Generic Medicine Diabetes 95

Quality Matters

APRIL 18, 2024

Leadership driving impact To fulfill this commitment and help drive impact, in 2023 USP created an ESG executive-level committee and multiple work groups across our organization focused on advancing related operational objectives. These USP documentary standards are recognized in U.S.

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Pharmaceutical Manufacturing Packaging Generic Medicine 59

Quality Matters

OCTOBER 24, 2023

Analysis leveraging USP’s Medicine Supply Map suggests many of the essential cancer medicines have inherently vulnerable supply chains and are at greater risk for shortage compared to other generic medicines. See Table 1 for the list of medicines and the detailed analysis.

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Hospitals Generic Medicine Chemotherapy 52

Quality Matters

MAY 22, 2023

Known as the USP Medicine Supply Map and launched in 2021, this capability leverages more than 250 million data points spanning 92% of generic medicines approved in the U.S. in a platform that assesses the vulnerability of specific medicines to supply chain disruptions.

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Generic Medicine Chemotherapy 52

Quality Matters

MAY 30, 2024

Drug shortages pose a significant, ongoing threat to our healthcare system and to the patients who rely on medicine for their wellbeing and survival. The USP Medicine Supply Map shows that 125 drug products were in shortage at the end of 2023, the highest number in a decade. drug shortages.

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Generic Medicine Hospitals Vaccines 49

Quality Matters

APRIL 26, 2023

host year for APEC in 2023. In my keynote remarks, I highlighted the following elements of a strong medicines supply chain. Known as the USP Medicine Supply Map and launched in 2021, this capability leverages more than 250 million data points – some proprietary, but mostly public – spanning 92% of generic medicines approved in the U.S.

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Prescription Filling Generic Medicine Packaging Labelling 52

Quality Matters

MAY 18, 2023

government’s fiscal 2023 funding bill , signed into law in December 2022, included a range of specific provisions to support medicines supply chain resilience, including those supporting development of AMT through creation of national centers of excellence. The supply of generic drugs has been unreliable for 15 years” in the U.S.,

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Generic Medicine Pharmaceutical Manufacturing 52

Quality Matters

SEPTEMBER 15, 2023

For example, while some stakeholders may perceive PCM to be primarily for innovators and not for makers of generic medicines or biotech companies, it “can be for generic companies, biotechnology companies, and so on, and we have had engagements with generic drug companies in our emerging technologies program already,” Fisher said.

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Generic Medicine Pharmaceutical Manufacturing Communication 52

Quality Matters

APRIL 20, 2023

Launched in 2021 and composed of more than 250 million data points spanning 92% of generic medicines approved in the U.S., kristine.gates… Thu, 04/20/2023 - 08:51 Supply Chain

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Biosimilars Labelling Vaccines Generic Medicine 52

Express Pharma

JUNE 15, 2024

India, synonymous with the “pharmacy of the world” has rightfully earned the title, owing to its remarkable contribution in supplying 20 per cent of the global generic medicines, along with 60 per cent of the total vaccine demand worldwide.

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Vaccines Generic Medicine 111

Quality Matters

JUNE 12, 2023

Complex generics: The need and challenges Generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions filled in the United States , generic medicines are essential to increasing patient access to important drug therapies.

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Generic Medicine Dosage Prescription Filling Diabetes 52

Express Pharma

SEPTEMBER 11, 2023

This move unburdened the private pharma companies allowing them to concentrate and strengthen their base, and they succeeded in gaining a national as well as international market presence as “global generic medicine manufacturers.” Prices of brands are paradoxically high Pharma contributes 43.2

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Generic Medicine Diabetes Immunization Immunity 69

Pharmaceutical Technology

DECEMBER 19, 2022

in 2022 to 1% in 2023 due to the “tightening of monetary and financial conditions”. Furthermore, for months, several financial institutions such as Bank of America and JP Morgan have been talking of a “mild recession” in 2023 for the US. by the end of 2023 and may continue to rise in 2024 to 5%.

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Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Generic Medicine 69