Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. Among the attendees, contract manufacturing organisations, service providers and experts were present.

Packaging 105

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. Since its inception, the Format has been instrumental in standardizing the submission process, ensuring that critical data is presented in a clear and consistent manner.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

JULY 29, 2024

The highlight of the session, according to the statement was an in-depth presentation by Dr Ranjit Barshikar, CEO of QbD/cGMP Consulting and United Nations Adviser, Geneva. Panelists emphasised the importance of skilled manpower, regular cleaning verification studies, and the application of machine learning in pharmaceutical manufacturing.

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Pharmaceutical Manufacturing Drug Development 104

PharmaTech

MARCH 25, 2025

This bulletin presents some design considerations for maximizing mixing efficiency in a tumble blender and selecting the most suitable features for a particular application. Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries.

Pharmaceutical Manufacturing 40

Pharmaceutical Manufacturing 40

Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.

Biosimilars 98

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

MAY 31, 2023

The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Yet the balance sheets of the pharmaceutical manufacturers included in the report showed limited evidence of this. Inventories grew to a combined total of $150bn in 2022, the analysis showed.

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Pharmaceutical Manufacturing Vaccines 111

Express Pharma

JUNE 15, 2023

Roche is working on the design of this modular facility and in this context also on the implementation of mobile robotics, which goes along with the need to have standardized interfaces that all mobile robot manufacturers can plug in to.

Packaging 98

Packaging Pharmaceutical Manufacturing 98

European Pharmaceutical Review

JULY 12, 2022

Microbes developing resistance to disinfectants is a major emerging problem in pharmaceutical manufacturing cleanrooms and, if left unchecked, could present a threat to drug quality and, therefore, human health. Reducing this concentration twice, the researchers found that at the lowest concentration M. luteus and S.

Pharmaceutical Manufacturing 111

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 111

European Pharmaceutical Review

JULY 1, 2022

The article, published in the Journal of Validation Technology ( JVT ), presents the case study of a company undergoing an investigation and developing a strategy for identifying worst-case sampling locations on equipment, after a regulatory auditor asked for such a rationale and no written documentation could be provided.

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Documentation Pharmaceutical Manufacturing 105

European Pharmaceutical Review

SEPTEMBER 22, 2022

At Climate Week NYC GSK presented its new Sustainable Procurement Programme, announcing a fresh agenda, outlining how they will support their suppliers to succeed in their bold environmental objectives: have a net zero climate impact and a net positive impact on nature.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing 105

pharmaphorum

NOVEMBER 24, 2022

However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceutical manufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer? But with a single dedicated cleanroom environment costing around $2.5

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Packaging 98

Express Pharma

OCTOBER 7, 2024

On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceutical manufacturing. The session began with a keynote address by Thiru M.

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Dosage Pharmaceutical Manufacturing Packaging 105

Pharma Mirror

JUNE 6, 2021

Terrassa (Barcelona): Telstar will be exhibiting the latest developments in aseptic technology for pharmaceutical production and integrated turnkey engineering & construction services for process facilities at Achema Pulse 2021. The company will be deploying a compelling portfolio of solutions in the field of pharmaceutical manufacturing.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

SEPTEMBER 24, 2024

Expert Educator: The session was led by Shoeb Kurawadwala, Founder and MD of CN Water and an expert in Water for Pharmaceutical Purposes. He applauded the PULSE initiative for focusing on this crucial aspect of compliance and stressed the importance of compliance with Revised Schedule M.

Dosage 101

Dosage Pharmaceutical Manufacturing 101

Express Pharma

JUNE 5, 2024

Also, the proliferation of antimicrobial resistance (AMR), where overuse of antibiotics leads to resistant bacteria, making infections harder to treat Additionally, pharmaceutical manufacturing consumes substantial amounts of solvents, which are typically highly toxic chemicals, as well as heavy metals.

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Packaging Documentation Compounding 98

FDA Law Blog: Biosimilars

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.

Drug Development 59

Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 59

Express Pharma

JANUARY 29, 2025

Priyanka Chigurupati, Executive Director, Granules India As India’s pharmaceutical industry cements its position as the world’s third-largest by volume, the upcoming Union Budget presents a crucial opportunity to accelerate our transformation into a global healthcare leader.

Pharmaceutical Manufacturing 66

Pharmaceutical Manufacturing 66

European Pharmaceutical Review

JULY 3, 2023

Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites. Most that received warning letters (68 percent) were FDF manufacturers of non-sterile, non-application products.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Labelling 105

Drug Channels

JULY 16, 2024

PBMs’ negotiating leverage against pharmaceutical manufacturers has been a key factor inflating the gross-to-net bubble —the ever-growing dollar gap between sales at brand-name drugs’ list prices and their sales at net prices after rebates, discounts, and other reductions. Pharmacies and Pharmacy Benefit Managers.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

pharmaphorum

MARCH 29, 2021

Companies are invited to submit a non-confidential proposal, which will be presented to the fund’s Scientific Selection Board. Successful projects will be selected later in the year.

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Pharmaceutical Manufacturing Compounding 64

European Pharmaceutical Review

AUGUST 31, 2023

[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Hospitals 97

Drug Channels

DECEMBER 10, 2024

PBMs negotiating leverage against pharmaceutical manufacturers has been a key factor inflating the gross-to-net bubble the ever-growing dollar gap between sales at brand-name drugs list prices and their sales at net prices after rebates, discounts, and other reductions. Pharmacies and Pharmacy Benefit Managers.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

MARCH 12, 2024

Notably, the revised guidelines eliminate the penalty clause and the requirement of a bank guarantee that were present in the previous guidelines. The intended beneficiaries are now specified as existing pharmaceutical manufacturing units with an average turnover of less than Rs. 500 crore over the last three years.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

European Pharmaceutical Review

APRIL 18, 2024

What are the three main challenges of monitoring pharmaceuticals in the environment? Andreas Häner (AH): Roche, along with other pharmaceutical companies, acknowledges concerns about pharmaceuticals in the environment (PiE). The difference between detection limits and quantitation limits is very important.

Pharmaceutical Manufacturing 97

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

Express Pharma

NOVEMBER 29, 2023

The CPHI and PMEC India Expo is comprehensively supported by industry associations such as BDMA (Bulk Drug Manufacturing Association), FOPE (Federation of Pharma Entrepreneurs), KDPMA (Karnataka Drugs and Pharmaceuticals Manufacturers’ Association), OPPI (Organisation of Pharmaceutical Producers of India), and PharmExcil.

Packaging 111

Packaging Pharmaceutical Manufacturing 111

Drug Channels

MARCH 14, 2022

Asembia’s Summit is back on its normal schedule and kicks off with pre-conference continuing education (CE) programming on Sunday May 1, 2022 followed by 3 days of informative business sessions, additional CE programs, collaborative networking opportunities, interactive exhibits, featured presentations and more.

Specialty Pharmacies 74

Specialty Pharmacies Pharmaceutical Manufacturing Hospitals 74

European Pharmaceutical Review

OCTOBER 23, 2023

1 In pharmaceutical manufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. Polyols present in this formulation are characterised by a melting point ranging between 90 and 110°C.

Compounding 98

Compounding Pharmaceutical Manufacturing 98

European Pharmaceutical Review

OCTOBER 21, 2022

Endotoxins are lipopolysaccharides present inside a bacterial cell that are released when they disintegrate. Ensuring products are free of contaminants has and will continue to be a vital part of the process of getting life-saving therapies to patients – the risk of causing further suffering to ailing individuals is out of the question.

Pharmaceutical Manufacturing 40

Pharmaceutical Manufacturing 40

Express Pharma

JUNE 1, 2024

Pharmaceutical manufacturing executives are facing a complex array of cybersecurity challenges, driven primarily by the sector’s increasing digitalisation and the high value of intellectual property. The burgeoning threats in cyberspace are as multifaceted as the opportunities that digital advancements present.

Pharmaceutical Companies 108

Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing Hospitals 108

Express Pharma

DECEMBER 11, 2024

The event is a joint initiative between AIPAC, Society for Pharmaceutical Dissolution Science (SPDS), Indian Drug Manufacturers Association-MP State Board (IDMA-MP), and Madhya Pradesh State Drugs and Pharmaceutical Manufacturers Association (MPSDMA).

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

AUGUST 30, 2022

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.

Vaccines 78

Vaccines Pharmaceutical Manufacturing Packaging 78

Quality Matters

SEPTEMBER 15, 2023

PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., It is not intended as a comprehensive summary or report.]

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage 52

European Pharmaceutical Review

AUGUST 17, 2022

Antibiotic production processes involve a risk that, if operations and waste management practices are not strictly controlled, antibiotic can leave manufacturing plants in waste water, for example, and enter the environment in concentrations that may increase the risk of AMR. Frontiers in Microbiology. Tell J, Caldwell D, Häner A, et al.

Hospitals 98

Hospitals Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

NOVEMBER 25, 2022

Located on the outskirts of the historic Italian city – home to Verdi and myriad architectural gems – the press launch and tour of the €85 million Chiesi development was a quintessentially Italian affair, based out of Chiesi’s San Leonardo production site.

Drug Development 98

Drug Development Pharmaceutical Manufacturing Diabetes 98

European Pharmaceutical Review

JULY 8, 2024

In the absence of any regulatory text, numerous presentations have been made on the subject, prompting debate and initiating reflection. From this observation, all options are possible. However, adoption is not simple and one point frequently made is the need to take historical data into account.

Pharmaceutical Manufacturing 95

Pharmaceutical Manufacturing 95

GMPSOP

FEBRUARY 28, 2024

Sometimes, pharmaceutical manufacturers employ surface profilometry to assess the roughness of stainless-steel equipment. Biological Contamination Biological contamination refers to contamination by bacteria, yeasts, molds, viruses, or any other microorganisms that may be present in the product. Checkout sample preview s.

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Documentation Packaging Pharmaceutical Manufacturing Compounding 98

European Pharmaceutical Review

NOVEMBER 8, 2022

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions.

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Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52