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.

Pharmaceutical Manufacturing 104

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

Pharmaceutical Technology

OCTOBER 24, 2023

The current war in Israel is a humanitarian crisis that presents major challenges to the region’s pharmaceutical manufacturing and export industry.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing 59

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.

Documentation 105

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.

Dosage 105

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

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

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

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

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

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

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.

Biosimilars 52

Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52

Express Pharma

APRIL 20, 2023

Sustainable future of the pharma industry Looking after the health and well-being of patients is a top priority for the pharmaceutical industry, but there are steps that should be taken to reduce environmental impact without compromising patient safety. Sustainability topic, you see that a lot of changes are going on with the packages.

Packaging 52

Packaging Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 26, 2022

Chiesi’s approach to these trials presents a clear demonstration of Chiesi’s patient-centricity approach in action. The status isn’t awarded lightly and Chiesi is the largest pharmaceutical manufacturer to be named a B Corp. “We Caring for a global community. Chiesi’s philosophy in action.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing 96

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

However, Judge Newman distinguished Michigan Bell from the present case because the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” See Motion at 11. Order at 22.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing Immunization Immunity 59

Putting Patients First Blog

APRIL 7, 2025

AI in Drug Discovery and Preclinical Development The integration of AI and ML into drug and biologic development presents transformative opportunities while introducing critical regulatory and ethical challenges. 3 ,4 The NHC is uniquely positioned to provide input on this issue.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

Quality Matters

SEPTEMBER 15, 2023

FDA’s Emerging Technology Program “Advanced manufacturing as a concept, as an initiative, has been very important to the agency,” emphasized workshop presenter Adam Fisher, Ph.D., Director, Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), FDA.

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Communication 52

PharmaShots

FEBRUARY 27, 2023

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

Packaging 52

Packaging Pharmaceutical Manufacturing Communication Pharmaceutical Companies 52

Viseven

JANUARY 13, 2023

HEOR (Health Economics and Outcomes Research) – is a common term used for experts who collect patient and medical data that proves the real value of the product, how it can influence the quality of life of the patient, and its capacity to compete against similar products present on the market. How HEORs Contribute to Research?

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

GMPSOP

MARCH 17, 2023

As a preventive action, the supplier of the carton was contacted and presented the issue. The supplier has taken action in their manufacturing process to improve the printing area which should stop the recurrence of the printing defect in the future. The entire unused packaging lot which was quarantined was returned to the supplier.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52