Everything you need to know about unannounced GPhC inspections

General Pharmaceutical Council | April 12, 2019

The General Pharmaceutical Council has introduced a new regime for the inspection of pharmacies, including three different types of inspections and inspections generally being unannounced. From 1 April 2019, the General Pharmaceutical Council (GPhC) began to introduce a new regime for the inspection of registered pharmacies. No date has yet been set for the first inspection but the system is due to be phased in during the 2019/2020 financial year, with the first inspection results published in the first quarter of that year. Some things will not change. Since the current system of inspections was introduced in November 2013, pharmacies expect to be inspected once every four or five years. For the vast majority of pharmacies, this is likely to continue. During the consultation period on the changes, which began in May 2018, some pharmacy bodies expressed concerns about aspects of the proposals. But the GPhC commissioned polling firm YouGov to survey 2,000 people who were broadly supportive of the new inspection system and it was approved by the GPhC council in December 2018.

Spotlight

On October 12, 2017, through Executive Order 13813, you directed the Administration, to the extent consistent with the law, to facilitate the development and operation of a health care system that provides high-quality care at affordable prices for the American people by promoting choice and competition. We are pleased to provide you with this report, prepared by the Department of Health and Human Services (HHS) in collaboration with the Departments of the Treasury and Labor, the Federal Trade Commission, and several offices within the White House

Spotlight

On October 12, 2017, through Executive Order 13813, you directed the Administration, to the extent consistent with the law, to facilitate the development and operation of a health care system that provides high-quality care at affordable prices for the American people by promoting choice and competition. We are pleased to provide you with this report, prepared by the Department of Health and Human Services (HHS) in collaboration with the Departments of the Treasury and Labor, the Federal Trade Commission, and several offices within the White House

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Hovione and Zerion Pharma announce a strategic partnership to market the Dispersome® technology platform

Hovione | February 23, 2022

Hovione, the leader in spray drying and particle engineering, announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome®, Zerion´s proprietary solubility enhancement technology platform. Zerion´s innovative Dispersome® technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome® technology with Hovione's unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility. "We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome® to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients. Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome®". Jean-Luc Herbeaux, Hovione´s Chief Operating Officer Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome® platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg. The announcement of this partnership follows Hovione's communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company's commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API, formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma ApS Zerion has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic outcomes for the patients. The Dispersome® technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin, a sustainable and biodegradable by-product from cheese production. Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

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PHARMACY MARKET

CPhI India Concludes the 2021 Hybrid Edition of CPhI - P-MEC Expo along with Informa Pharma Intelligence

Informa Pharma Intelligence | December 06, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partner, concluded its involvement at this year's CPhI & P-MEC Expo, a hybrid conclave hosted between 24th to 26th November 2021 at India Expo Centre – Greater Noida, New Delhi, and at the Online Conference & Networking event held between 15th to 30th November 2021. The conclave witnessed participation from key influencers and leading figures across the pharmaceutical industry, and hosted domestic and foreign drug makers, contract service providers and pharma machinery players under one roof, providing them with a chance to craft future growth plans together. India's pharmaceutical market is in the midst of a growth spurt, having increased in value from $21bn in 2016 to $29bn in 2020 – a figure that is expected to reach $41bn by 2024. Key industry drivers include a rise in disease prevalence, economic growth and higher disposable incomes, improvements in the healthcare infrastructure and a growth in the number of people covered by health insurance. In a bid to stay afloat during the need to step up the demand towards high quality, low-cost pharma solutions, CPhI & P-MEC India has curated a gateway to network with industry peers for the latest trends and innovative solutions that the market has to offer. The event is geared towards building pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally and cover the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. Alongside the expo, and under the aegis of the India Pharma Week, an exclusive and strategic closed door CEO Roundtable meeting took place, inviting the top leaders of India's pharmaceutical companies. The 'CEO Roundtable' was conducted on November 24 in partnership with Informa Intelligence, whose perspectives and key discussion points will also yield a white paper report. The pharama industry is anticipated to have a steady growth trajectory and the event organised by CPhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally, the event aims to encourage the development of the research-based pharma fraternity. Concluding the CPhI – P-MEC India show, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence, said, "We, at Informa Pharma Intelligence, were delighted to witness the overwhelming response at CPhI & P-MEC India 2021 event and we're glad that we could partner with CPhI to host this common platform for the pharmaceutical industry. With challenges and opportunities evolving at a global scale, through this event we looked to discuss the possibilities for not only providing solutions to the healthcare needs of the country but also to the world. With India's strength in global generics market, Indian pharma and biotech companies are now gearing up to transition into R&D and innovation to establish themselves as key players to develop Biosimilars, Novel Chemical Entities, Novel Biological Entities and Innovative Therapies for the global and Indian pharmaceutical markets, for which Informa Pharma Intelligence is closely partnering to aid in this effort. The event provided a great opportunity to reconnect with our stakeholders of the pharmaceutical world and offer data intelligence and analysis on par with the recent industry trends." "The Indian pharmaceutical market is growing exponentially, around twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore; we are glad that the platform by CPhI & P-MEC India could enrich the exhibitors with new pharma solutions and help businesses find the right partners, with the hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. We look forward to hosting CPhI P-MEC in the coming year's again." Mr.Yogesh Mudras, Managing Director, Informa Markets in India CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already known as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals, and R&D activities, to deliver the data required to make critical decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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