pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

Compliance 105

Compliance Manufacturing Life Science Production 105

Drug Patent Watch

DECEMBER 10, 2024

Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.

Compliance 98

Compliance Manufacturing Production Regulation 98

Pharmaceutical Technology

MAY 19, 2024

Discover what industry professionals seek in contract manufacturing for parenteral solutions. Ensure quality, compliance, and innovation with our comprehensive guide. Click to learn more.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Compliance 130

Pharmaceutical Commerce

JULY 25, 2023

With FDA’s compliance deadline only three months away, the tech-supply chain partnership is expected to help manufacturers and wholesalers meet the Nov. 27 deadline.

Compliance 98

Compliance Manufacturing 98

Drug Patent Watch

JANUARY 29, 2025

Factors such as raw material sourcing, manufacturing costs, regulatory compliance, and distribution networks all contribute to the final price of the generic medication. Manufacturers must invest in rigorous testing and quality control measures to ensure that their raw materials meet stringent standards.

Generic Drugs 78

Generic Drugs Production Compliance Drugs 78

XTalks

JANUARY 30, 2025

Benefits of Oral Liquid Dosage Forms Paediatric dosage forms (PDFs) provide considerable advantages over traditional oral solid dose (OSD) products, particularly in terms of improving patient compliance and ensuring therapeutic effectiveness. One of the most significant benefits of PDFs is their ease of administration.

Manufacturing 52

Manufacturing Development Compliance Production 52

Drug Patent Watch

DECEMBER 11, 2024

As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. Green Chemistry and Sustainable Manufacturing Green chemistry principles play a significant role in reducing environmental impacts.

Generic Drugs 98

Generic Drugs Development Drugs Compliance 98

Pharmaceutical Technology

OCTOBER 10, 2024

At CPHI Europe, an expert discussed the promise of gummies as a drug delivery system and their unique manufacturing challenges.

Drug Delivery Systems 130

Drug Delivery Systems Drug Delivery Compliance Drugs 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Hence the affordability of these medicines are a complex issue, said Dr Amaresh Tumbagi, Karnataka additional drugs controller.

Production 188

Production Clinical Trials Clinical Trials Compliance 188

Drug Patent Watch

OCTOBER 24, 2024

With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. Food and Drug Administration… Source

Generic Drugs 100

Generic Drugs Drugs Compliance Regulation 100

Drug Patent Watch

MARCH 13, 2025

From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

Production 52

Production Compliance Manufacturing Marketing 52

Drug Patent Watch

AUGUST 28, 2024

The EU’s Good Manufacturing Practice (GMP) guidelines provide the minimum standards for API manufacturing, and compliance with these guidelines is mandatory for all manufacturers and importers of APIs intended for the EU market.

Compliance 59

Compliance Manufacturing Medicine Marketing 59

Cloudbyz

APRIL 25, 2023

A vital aspect of pharmacovigilance is regulatory reporting, which facilitates effective communication between pharmaceutical companies, medical device manufacturers, and regulatory authorities. Compliance: Adhering to the regulatory requirements for safety reporting is vital for maintaining compliance and ensuring patient safety.

Compliance 97

Compliance Clinical Trials Clinical Trials Manufacturing 97

XTalks

JULY 26, 2024

In today’s rapidly evolving food industry, enterprise resource planning (ERP) systems for food manufacturers are essential. They ensure efficiency, compliance and profitability. Wherefour , a leader in ERP solutions, is transforming and simplifying how food and beverage companies manage production and compliance.

Compliance 52

Compliance Manufacturing Production Packaging 52

FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Drugs Compliance Pharmacy 105

pharmaphorum

JULY 21, 2022

This means there will be increased regulatory inspections over the next 12-18 months, so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. Doing so means that businesses can check their compliance before an FDA inspection. Upgrading facilities.

Compliance 98

Compliance Regulation Manufacturing Contamination 98

Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. Formulation decisions made in the development of PDFs can have important implications for drug stability, patient compliance, and accurate dosing. Advanced manufacturing technology and expertise in formulation sciences and process development are critical.

Manufacturing 130

Manufacturing Production Pharma Companies Development 130

Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

Generic Drugs 92

Generic Drugs Drugs Contamination Manufacturing 92

Pharmaceutical Technology

NOVEMBER 22, 2022

This approach to vaccination offers many advantages to developers, including quick development, high potency, a favorable safety profile, and the potential for cost-effective manufacturing. Cytiva offers solutions across the mRNA manufacturing workflow, from plasmid linearization to aseptic filling.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

Drug Patent Watch

DECEMBER 11, 2024

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs). Transparency Regarding Costs Understanding the costs associated with working with a CDMO is crucial.

Compliance 98

Compliance Development Manufacturing Production 98

Drug Channels

MARCH 18, 2022

As Ashwin explains, manufacturers face a gap between visible, non-compliant drug discounts and the actual level of non-compliant discounts. He describe Kalderos’ technology-enabled, machine learning-based methods for identifying drug discount non-compliance.

Manufacturing 98

Manufacturing Drugs Compliance 98

pharmaphorum

DECEMBER 29, 2022

The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. The net effect has been to stimulate change in every aspect of the pharma industry – an industry not exactly known for its embrace of manufacturing innovation.

Manufacturing 111

Manufacturing Medicine Pharma Companies Engineer 111

XTalks

NOVEMBER 6, 2024

XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with an AI-Powered eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST ( 4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.

Manufacturing 104

Manufacturing FDA Approval Packaging Packaging 104

XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

Pharmaceutical Technology

JUNE 29, 2022

For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The enzymes must be manufactured under cGMP conditions – completely free of animal-derived ingredients.”. Developing best-in-class speciality enzymes.

Drugs 295

Drugs Gene Therapy Production Manufacturing 295

Pharmaceutical Technology

DECEMBER 15, 2022

In June, generic drug manufacturing giants wrote to the EU to request help with rising costs so that their products remain viable. It also stresses that some pharma manufacturers are at risk of having gas rationed or being unable to continue manufacturing due to high prices.

Medicine 246

Medicine Manufacturing Pharma Companies Production 246

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

XTalks

OCTOBER 31, 2024

XTALKS WEBINAR: Unlock Growth in Medical Device Manufacturing with AI-Integrated eQMS Live and On-Demand: Monday, December 9, 2024 , at 11am EST (4pm GMT / UK) Register for this free webinar to discover how AI integration can transform compliance, streamline operations and position medical device manufacturers for unprecedented growth.

Manufacturing 105

Manufacturing Compliance Production Development 105

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

Pharma Mirror

DECEMBER 1, 2021

CPhI awards the first ever CPhI Verified certificate to Medinfar – an international pharmaceutical manufacturer of Rx, cosmetics, food supplements and veterinary products. The service forms part of the platinum membership on CPhI Online and is designed to further supply.

Cosmetics 130

Cosmetics Compliance Branding Manufacturing 130

Drug Patent Watch

DECEMBER 12, 2024

Key Factors Influencing Generic Entry To identify branded drugs with a low likelihood of generic entry, it’s crucial to understand the factors that influence generic manufacturers’ decisions to enter a market. This complexity can serve as a barrier to entry for potential generic manufacturers.

Licensing 96

Licensing Licensing Branding Drugs 96

Pharma Mirror

OCTOBER 29, 2021

At CPhI, the company will also be unveiling a specialized consultancy service, an expert in compliance with GMP requirements in critical manufacturing processes while offering fully comprehensive assistance encompassing the whole life cycle of the drug.

Engineer 130

Engineer Compliance Manufacturing Production 130

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Compliance 64

Compliance Manufacturing Regulation In-Vitro 64

Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

The acquisition will expand the international solutions portfolio of AmerisourceBergen aiding in advancing its position as a preferred partner for biopharmaceutical manufacturers. This approach will support its manufacturer partners throughout the pharmaceutical development and marketing processes.

Manufacturing 130

Manufacturing Compliance Marketing Clinical Development 130

XTalks

DECEMBER 7, 2023

These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. It extends recordkeeping obligations beyond current regulations to those who manufacture, process, pack or hold FTL foods.

Compliance 59

Compliance Manufacturing Regulation Production 59