Partner with the Global Leader in Drug Delivery Systems
|
|
- Alexandrina Ellis
- 6 years ago
- Views:
Transcription
1 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Loughborough, United Kingdom Manufacturing Facility Experts at Commercializing Innovation
2 3M: Transforming New Ideas into Thousands of Ingenious Products 3M is a global innovation company that never stops inventing. Over the years, our innovations have improved daily life for hundreds of millions of people and businesses all over the world. Every day at 3M, one idea always leads to the next, igniting momentum to make progress possible around the world. On average, every person will come into contact with a 3M product or technology 17 times a day. Electronics & Energy Industrial Consumer Health Care Safety & Graphics Innovation on a Global Scale With subsidiaries in more than 70 countries and operations in nearly 200 countries, 3M is truly a global company. Currently, 3M offers more than 60,000 products which generate sales in excess of US$ 30 billion. And with almost 90,000 employees worldwide, 3M has local presence across its global markets. 3M has five global business groups, one of which is Health Care. Ingenious Solutions Transforming Health With a depth of diverse technologies, a culture of collaboration and a global footprint, 3M Health Care is a leader in delivering innovative solutions. As the creators of the metered dose inhaler, the Drug Delivery Systems division has a proven history of drug delivery. At 3M Health Care and 3M Drug Delivery Systems, our innovations help improve the quality, cost and outcomes of care.
3 Drug Delivery Systems: It s in the detail As a pioneer in the development of intuitive, patient-friendly technology, 3M understands how to deliver life saving medication. From development to commercial scale manufacturing, we have over 50 years of knowledge and innovation that goes into everything we do. You can t always see our innovation, but look again, because it is there in the detail. Inhalation Reducing the risk of commercializing innovation Transdermal Optimize delivery and increase patient comfort Microneedle Increasing commercial success with patientfriendly solutions Having created the first metered dose inhaler (MDI) over 50 years ago, 3M has the experience and expertise to help commercialize your product. We offer MDIs with the 3M Integrated Dose by Dose Counters, a full range of inhaler components, and provide both pressureand cold-fill contract manufacturing. A transdermal form of your drug can help to differentiate your product while offering patients a more comfortable, convenient and effective way to receive their medications. 3M Microstructured Transdermal Systems (MTS) offer patient-friendly solid and hollow microneedle technology. By offering patients the efficiency of a syringe with the comfort and convenience of a patch, these technologies can help increase the commercial success of your product. Oral & Topical A partner you can trust, quality you can count on Worldwide Manufacturing Facilities Capabilities 3M is your low-risk contract manufacturing partner for a broad range of oral and topical dosage forms, offering security, service and sound value with end-to-end solutions you can trust. Inhalation Cold-fill Inhalation Pressure-fill St. Paul, MN Northridge, CA Loughborough, UK Hurlingham, AR Transdermal Nasal Gain an edge in your nasal market Oral/Topical Pilot scale Featuring no-drip aerosol delivery, 3M Nasal MDI technology is ideal for partners wanting a rapid, cost-effective extension of their inhaled product and for those seeking a device edge for new nasal treatments. Small scale Intermediate scale Large, commercial scale ISO-7 certified DEA CII-CIV compliant Packaging Films Clinical supply manufacturing Reliable packaging delivers confidence Toxicology supply manufacturing 3M Scotchpak Packaging Films can withstand every part of the product lifecycle delivering a high level of confidence, even for the most challenging applications. Inspections FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR, INVIMA
4 3M Loughborough, United Kingdom: Local Knowledge, Global Resources With long-standing expertise in inhalation, oral and topical drug delivery, 3M Loughborough offers a dedicated local team backed by a truly global support network. Our culture of continuous improvement, customer focus and the ability to handle complex problems have made us a global centre for the manufacture of inhalation, oral and topical products. Our responsive local team can help you reduce the risk of commercializing your next oral, topical or inhaled product. With state-of-the-art cgmp compliant manufacturing including cold-fill capabilities as well as flexible options for capsules, tablets, creams and gels we are ready to become your trusted partner. Technical Expertise to Get You to Market Faster Our team has the experience, capacity, and extensive quality and regulatory expertise to support our customers through every step of the product commercialization process: Screening one or more compounds for compatibility with one of our drug delivery technologies. Evaluating formulation, process and component variables in the feasibility phase to ensure smooth product development and commercial scale-up. cgmp contract manufacturing capabilities offering flexible batch sizes to support market needs. Regulatory support with a proven track record including six single-cycle FDA reviews in six years. Local presence, with a deep understanding of the unique culture and regulatory processes in the region. A global leader in oral and topical drug delivery, we have the experience to maximize the potential of your formulation. At 3M Loughborough, we are experts at commercializing innovation. Post launch technical support for regulatory changes, line extensions, and product updates. Laboratory Pilot Facility Commercial Facility Formulation Development Early Phase Development Full Development Commercial Supply Assess feasibility of delivering API through solubility, compatibility and prototype system pharma performance Refine the system for optimum performance, product toxicology and early clinical supplies Finalize design Complete method validation Scale up process Produce late-stage clinical supplies Complete registration stability Submit regulatory dossier Produce validation & launch supplies Post launch technical support
5 High Quality Production and Reliable Supply 3M understands oral, topical and metered dose inhaler (MDI) manufacturing from start to finish. We ask better questions and use Lean Six Sigma processes to get you ready for market faster. For topical delivery, we can handle a wide range of viscosities with packing in aluminum or plastic tubes. We also offer delivery via large and small sachets. This convenient form allows for dosing in small quantities as low as 0.25g. For oral capsules we offer a wide variety of options including controlled release formulations, aqueous and solvent coating, powder/bead encapsulation and extrusion and spheronisation for beads. For oral tablets we offer fluid bed and tray drying, tablet compression and multiple compression suites. For MDI, we offer cold-fill capabilities, nasal inhalers and dose by dose counters. Whether it s oral, topical or MDI, we can handle any size project from clinical to commercial supply. MDI Cold-fill capabilities Powder handling technologies and custom micronization Small to large batch, commercial scale facilities Globally-compliant facilities that are always audit ready ORAL & TOPICAL Creams, gels, liquids, beads, capsules and tablets Oral, topical, buccal and sublingual Instant and controlled release formulations Pumps, blisters, bottles, sachets and tubes Automated and semi-automated packaging options High-toxicity API handling capabilities We are experts at commercializing innovation. So with our proven technical, regulatory and production experience, you can proceed with total confidence. Certifications: ISO 9001 (2008) ISO (2003) FDA approved (US) MHRA approved (EU) Registrations in over 60 countries
6 3M Loughborough Capabilities, Services and Quality Control Inhalation Drug Delivery Cold filling manufacturing capabilities Potent compound handling and size reduction Clean in place (CIP) systems for quick cleanings and changeovers Concentrate preparation vessels with low or high shear mixing Batch formulation vessels with in-tank agitation and continuous recirculation to fill table Isolator technologies used in sampling and formulation of hazardous materials Oral Drug Delivery (Capsules) Extrusion & spheronisation for beads Aqueous and solvent coating Powder/bead encapsulation Controlled release formulations Oral Drug Delivery (Tablets) Multiple granulation suites Fluid bed and tray drying Tablet compression Topical Drug Delivery Accurate dosing of small fill weights Wide range of viscosities Large and small sachets Aluminium & plastic tubes Pump filling Liquids Manufacturing 4500 litre manufacturing plant Integrated bottle packaging line Plastic and glass bottles Packaging Fully segregated & flexible GMP facilities Full range of packaging techniques Blister/bottle packaging for tablets and capsules Cream sachet and powder sachet filling Liquid bottle filling Packing capability for tubes Pump filling Automated/semi-automated packaging solutions Plant Analytical Laboratory Physical-chemical laboratory Stability chambers (25C/60RH; 40C) Spectrophotometers (FTIR, UV-VIS, Hand-Held NIR) Compendia testing Full micro laboratory Quality Assurance World Class Pharmaceutical Global Quality Systems Implemented (Q10) Finished product complete release Lean Six Sigma Change Management Deviations and Quality Incidents Management Corrective And Preventive Actions (CAPAs) Annual Product Review Supply Chain Capabilities Validation inventory management system for warehouse and materials management Temperature-controlled warehouse (<25 C/<77ºF) Flammable products warehouse Use of heat-treated wooden pallets Established S&OP (Sales & Operations Planning) process In-house Packaging Engineering Team Site wide Lean Management System implementation
7 From Start to Finish, 3M is the Right Partner for All Your Manufacturing Needs: 3M is a stable company to select for your product supply 3M has the global capability for development and commercial manufacturing 3M has a commitment to quality and continuous improvement Business Card 3M has over five decades of proven success in drug development, manufacture and delivery to market. Contact us at 3M.com/DDS to receive an initial, cost-free paper feasibility assessment and to begin partnering with us to commercialize your innovation.
8 About 3M Loughborough This 18-acre site opened in M Loughborough has facilities for manufacturing, supply chain management and distribution and R&D. We specialize in contract manufacturing of oral, topical and inhalation drug delivery systems. 3M House Morley Street Loughborough, Leicestershire LE11 1EP England (44) Fax (44) M.com/DDS Additional Facilities 3M Argentina Los Arboles 842, Hurlingham (1686) Buenos Aires, Argentina (54) M.com/DDS 3M Northridge Nordhoff Street Northridge, CA USA (1) Fax (1) M.com/DDS 3M Center Building E-10 St. Paul, MN USA (1) Fax (1) M.com/DDS 3M and Scotchpak are trademarks of 3M Company. 3M All Rights Reserved Experts at Commercializing Innovation
Partner with the Global Leader in Drug Delivery Systems.
3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems. Hurlingham, Argentina Manufacturing Facility Experts at Commercializing Innovation 3M is a global innovation company that
More informationPartner with the Global Leader in Drug Delivery Systems.
3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems. Hurlingham, Argentina Manufacturing Facility Experts at Commercializing Innovation Drug Delivery Systems: It s in the detail
More informationLeader in custom manufacturing. for the pharmaceutical and nutraceutical industries.
Leader in custom manufacturing for the pharmaceutical and nutraceutical industries. Since its inception in April 1994, Viva Pharmaceutical Inc. has built a reputation as a leading manufacturer committed
More informationThe Soft Gel Specialist
Renown PHARMACEUTICALS PVT. LTD. The Soft Gel Specialist Prestigious History Welcome to Renown Pharmaceuticals Demand for Soft Gelatin Capsules is ever increasing for Nutraceuticals, Cosmetics and Herbals.
More informationinnovative products. faster to market. reliably supplied.
innovative products. faster to market. reliably supplied. consumer health E DEVELOPMENT DELIVERY SUPPLY We create unique, tailored consumer health solutions to help your brand grow. With more differentiated
More informationinnovative products. faster to market. reliably supplied.
innovative products. faster to market. reliably supplied. consumer health unique consumer health solutions for otc, supplements & beauty DEVELOPMENT DELIVERY SUPPLY As a global leader in the development
More information040716_ANDI_VENTIS WEBSITE(new) Printout 1. HOME PAGE. Welcome to our world of Dry Powder Inhalers!
1. HOME PAGE Welcome to our world of Dry Powder Inhalers! Andi-Ventis Ltd, established in 2001 is a joint venture between Medochemie Ltd, Cyprus and Miat SpA Italy, founded to carry out the pharmaceutical
More information67 Years of Leadership in Pharmacy. A Journey of Continuous Improvement
67 Years of Leadership in Pharmacy A Journey of Continuous Improvement September 2012 GALENIKA A.D. IS The only Serbian state-owned pharmaceutical company Manufacturer of generic drugs its manufacturing
More informationSub-components in Nicotine cessation products?
Sub-components in Nicotine cessation products? Mr Arun Sarda, Director of Quality and Regulatory Affairs Member of the HEITKAMP & THUMANN GROUP Regulatory approval of sub-components in nicotine cessation
More informationBoehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence
Boehringer Ingelheim BioXcellence Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence Producing Value Boehringer Ingelheim
More informationInnovator in Chelated Mineral Nutrition
Leader The World & Innovator in Chelated Mineral Nutrition 2011 Albion Human Nutrition. All rights reserved. Albion Manufacturing Technologies, Ogden Utah Albion Central Warehouse, Ogden Utah Albion Corporate
More informationGraft Delivery Devices
Graft Delivery Devices About Graft Delivery Devices Nordson MEDICAL Nordson MEDICAL is your partner in the global life sciences market providing innovative components, devices and custom OEM solutions
More informationSTARCH Proven and Trusted Excipient for Performance and Versatility EXCIPIENTS. Effective and economical disintegrant
EXCIPIENTS STARCH 1500 Proven and Trusted Excipient for Performance and Versatility Effective and economical disintegrant Excellent stability for moisture sensitive drugs Manufactured exclusively for the
More informationWelcome to Galenicum! APRIL, 2013
Welcome to Galenicum! APRIL, 2013 Our corporate image comes from the sunrise. Night represents disease, daylight means health and the sunrise stands for overcoming GALENICUM CORPORATE PRESENTATION 3 Who
More informationThe Wright Grou. the history of
the history of The Wright Grou Based in Crowley Louisiana, the Wright family has been a global leader in the rice industry for over 100 years. Founded by S.L. Wright Jr., The Wright Group has grown into
More informationANIMAL HEALTH DIVISION. Technologies & Services
ANIMAL HEALTH DIVISION Technologies & Services Friulchem AH division is a fully compliant with the EU cgmp. Since 2007, it is a dedicated finished product manufacturer and R&D service provider for the
More informationCapturing lightning In A Bottle
Capturing lightning In A Bottle Featured In: Manufacturing & Capabilities I Facility of the Year I ISPE By Stephen Hall, Senior Director, Engineering, MannKind Corporation; Juergen Martens, Chief Technical
More informationTaking Health & Nutrition to the NEXT Level
Taking Health & Nutrition to the NEXT Level 1. Who We are 2. Softigel by Procaps 3. Strategically Located sites Take 10 minutes to get to know us better 4. Our Quality Certifications 5. Product Development
More informationThe Nutraceutical Solutions! CERTIFIED ISO
The Nutraceutical Solutions! CERTIFIED ISO 22 000 PROVIDER OF NUTRACEUTICAL SOLUTIONS OUR MISSION is to contribute to the business development of our B to C customers by providing innovative nutraceutical
More informationBoehringer Ingelheim Biopharmaceuticals in China. Your Reliable Contract Manufacturing Solution Provider
Boehringer Ingelheim Biopharmaceuticals in China Your Reliable Contract Manufacturing Solution Provider Dr. Bin Wang, Dr. Axel Schleyer Boehringer Ingelheim Biopharmaceuticals (China) Co., Ltd. Contact:
More informationPPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM
HEMATOLOGY ONCOLOGY PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM COMMITTED TO ADVANCING DRUG DEVELOPMENT IN ONCOLOGY $ MARKETPLACE COMPLEXITIES increasingly competitive marketplace and rising cost pressures
More informationSolid and sterile finished dosage forms. Delivered.
Solid and sterile finished dosage forms. Delivered. This is where your discoveries take form. Oral Solids Access a remarkable range of conventional and specialized oral solid dosage form capabilities and
More informationabout us Cyndea Pharma independent
2014 02 about us Cyndea Pharma is an independent Spanish laboratory specialized in the development and manufacturing of generic formulations all of which is done in the latest state-of-the-art high containment
More informationORAL DOSAGE OVERVIEW
ORAL DOSAGE OVERVIEW AN UNWAVERING COMMITMENT TO ENABLING LIFE-SAVING PHARMACEUTICALS The safety of your patients is your number one priority. That s why the quality and stability of your formulations
More informationMedical Device VSP Design & Manufacturing. Virtual Surgical Planning
Medical Device VSP Design & Manufacturing Virtual Surgical Planning Overview 3D printing technology is at an inflection point with the medical device industry rapidly adopting 3D printing technology. This
More informationYour Partner in Healing
Your Partner in Healing Euromed provides all functions necessary for market-ready hydrocolloid wound dressings. With fully integrated services, Euromed is one of a select few custom hydrocolloid manufacturers
More informationDUAL CHAMBER SYSTEMS
DUAL CHAMBER SYSTEMS HEALTH is the inestimable value to which Pharmaceutical Industry is committed. BORMIOLI PHARMA contributes to this mission by following the same values that guide this industry: quality,
More informationAN INTRODUCTION TO YPSODOSE FOR THE LARGE-VOLUME INJECTION OF BIOLOGICS
AN INTRODUCTION TO YPSODOSE FOR THE LARGE-VOLUME INJECTION OF BIOLOGICS In this article Ian Thompson, Vice-President Business Development at Ypsomed, describes self-injection device trends for larger injection
More informationBoehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence
Boehringer Ingelheim BioXcellence Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence Producing Value Boehringer Ingelheim
More informationNew formulas for successful drug delivery Hot-melt extrusion for enhanced solubility and bioavailability
New formulas for successful drug delivery Hot-melt extrusion for enhanced solubility and bioavailability Andreas Gryczke, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities.
More informationNUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS
NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS Growing expertise in healthy dietary supplements At the mouth of the River Elbe, at the edge of the Lower Saxony Wadden Sea National Park, Nutrilo
More informationDow Wolff Cellulosics. Using ingenuity and savvy. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow
Dow Wolff Cellulosics Pharmaceutical Excipients Using ingenuity and savvy to help design healthcare solutions TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Enhancing
More informationHARD TWO-PIECE HPMC CAPSULES FOR PHARMACEUTICAL APPLICATIONS IN INHALATION
HARD TWO-PIECE HPMC CAPSULES FOR PHARMACEUTICAL APPLICATIONS IN INHALATION 2 3 QUALICAPS HISTORY Over one hundred years of experience in the manufacturing and filling of hard two-piece capsules Qualicaps
More informationSavesta Herbals is engaged in manufacturing
Savesta Herbals is engaged in manufacturing standardized herbal extracts that synergistically combine the ancient wisdom of Ayurveda with the modern production and QC methods. Our state-of- the- art production
More informationADVANCIA : A TRUE PLATFORM & INNOVATIVE SYSTEM OFFERING EFFICIENT NASAL DOSE DELIVERY
ADVANCIA : A TRUE PLATFORM & INNOVATIVE SYSTEM OFFERING EFFICIENT NASAL DOSE DELIVERY Millions of people suffering from allergic rhinitis use nasal sprays manufactured by Nemera every day. In this article,
More informationTHE COMPLEX JOURNEY OF A VACCINE PART I The manufacturing chain, regulatory requirements and vaccine availability
THE COMPLEX JOURNEY OF A VACCINE PART I The manufacturing chain, regulatory requirements and vaccine availability International Federation of Pharmaceutical Manufacturers & Associations THE COMPLEX JOURNEY
More informationLYCOAT. New solutions for Film Coating from Roquette. LYCOAT for quicker quality coating
LYCOAT New solutions for Film Coating from Roquette LYCOAT for quicker quality coating Roquette LYCOAT New solutions for Film Coating from Roquette LYCOAT New solutions for Film Coating Film coating, the
More informationBecause you want to achieve your best possible health
Because you want to achieve your best possible health High Quality Formulas Our industry-leading quality and reliability is why your practitioner chooses and trusts XYMOGEN s formulas. Finding the best
More informationFood Supplement Innovation
Swadlincote Site Food Supplement Innovation Nick Bennett RNutr. Food Matters Live, November 2014 21/11/2014 Slide 1 Introduction Brunel Healthcare is the largest contract manufacturer of food supplements
More informationA matter of timing. ensure optimal delivery for acid-sensitive products. capsugel.com
A matter of timing ensure optimal delivery for acid-sensitive products capsugel.com The preferred choice for you and your customers Capsugel DRcaps capsules offer nutritional supplement makers a dosage
More informationA NEW, ADVANCED HIGH- THROUGHPUT SYSTEM FOR AUTOMATED INHALER TESTING
A NEW, ADVANCED HIGH- THROUGHPUT SYSTEM FOR AUTOMATED INHALER TESTING Two years ago, Novi Systems Ltd set out to shake up the inhaler automation market. On December 8th, 2015, at the Drug Delivery to the
More informationaesthetic cannula innovations
Silkann. A complete range of Sterimedix single-use needles and flexible cannulas for the injection of dermal fillers and other aesthetic procedures. aesthetic cannula innovations single-use innovation
More informationThe right choice for your health
The right choice for your health High-quality herbal supplements you can trust, only available through your qualified health care professional Why is MediHerb only available through my health care professional?
More informationMAKE THE CLEAR CHOICE. IV Products and Accessories Designed to Help Maximize Clinical Performance While Optimizing Savings
MAKE THE CLEAR CHOICE. IV Products and Accessories Designed to Help Maximize Clinical Performance While Optimizing Savings EXCEPTIONAL QUALITY, PERFORMANCE AND VALUE. Infuse medications and fluids accurately
More informationVIVAPHARM PVP/VA. Copovidone, Ph.Eur. USP/NF, JPE, E. The Ultimate Tablet Binder for All Processing Technologies
VIVAPHARM PVP/VA Copovidone, Ph.Eur. USP/NF, JPE, E 1208, FCC The Ultimate Tablet Binder for All Processing Technologies Direct Compression Dry Granulation Hot Melt Extrusion Wet Granulation VIVAPHARM
More informationSMARTPILOT FOR YPSOMATE: TRANSFORMING A PROVEN AUTOINJECTOR INTO A FULLY CONNECTED DEVICE
SMARTPILOT FOR YPSOMATE: TRANSFORMING A PROVEN AUTOINJECTOR INTO A FULLY CONNECTED DEVICE In this article, Orfeo Niedermann, Business Development Director, Ypsomed Delivery Systems, provides insights into
More informationSOMNUS VITM Supplement for sleep and wellness
SOMNUS VITM Supplement for sleep and wellness Unscheduled and non-psychoactive, CANNABINOL represents a major market opportunity as a sedative as well as a potential treatment for insomnia, anxiety and
More informationQ&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution)
Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution) This document should not be treated as a comprehensive guideline; it serves as a
More informationExcipient Considerations for Continuous Manufacturing Implementation
Excipient Considerations for Continuous Manufacturing Implementation FDA-PQRI Conference March 22-24, 2017 David R. Schoneker Director of Global Regulatory Affairs Email: dschoneker@colorcon.com 1 Continuous
More informationDeviations Inspection Observations & Issues to Consider for Achieving Compliance
Deviations Inspection Observations & Issues to Consider for Achieving Compliance Kevin O Donnell, Ph.D. Market Compliance Manager Irish Medicines Board IMB GMP & Market Compliance Information Day Dublin,
More informationYOUR ORAL SOLID DOSE. In pursuit of excipient excellence
YOUR ORAL SOLID DOSE DFE Pharma globally supplies a unique, broad portfolio of key excipients including lactose, MCC, superdisintegrants and starches. Innovative products such as SuperTab 24AN and SuperTab
More informationFOUR INTEGRATED THERAPEUTIC MODALITIES ONE REVOLUTIONARY RECOVERY SYSTEM RECOVERY RE-ENGINEERED
FOUR INTEGRATED THERAPEUTIC MODALITIES ONE REVOLUTIONARY RECOVERY SYSTEM RECOVERY RE-ENGINEERED GET PEOPLE BACK TO BEING THEIR BEST WITH THE BREAKTHROUGH, MULTI-MODALITY INJURY AND SURGERY RECOVERY SYSTEM
More informationPFC Industry Courses and Certifications
PFC Industry Courses and Certifications Americans for Safe Access (ASA) has been a trusted source of cannabis education and training for over 15 years. As a leader in medical cannabis education since 2002,
More informationAlignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference
Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference Donald Kautter US Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food
More information300 3PORTUGUESE 65M GLOBAL WHO WE ARE WE OFFER PORTUGUESE
WHO WE ARE PORTUGUESE WE OFFER Licensing out Contract Manufacturing Packaging Services EU Batch Release R&D Services Marketing & Distribution Medinfar is a fully integrated Pharmaceutical Company with
More informationContract Manufacturing Fluid Bed Technology. Drying. Spray granulation. Coating. Agglomeration. Instantization.
Contract Manufacturing Fluid Bed Technology Drying. Spray granulation. Coating. Agglomeration. Instantization. Multifunctional fluid bed processor State-of-the-art fluid bed technology for a diversity
More informationTRANSDERMAL INNOVATION
TRANSDERMAL INNOVATION 2 TRANSDERMAL MILESTONES Success starts with a vision. An idea that will make a difference. A goal you never lose sight of. At LTS, this goal has always been clear: To offer alternatives
More informationInnovations in Administration and Injection Systems EXPERIENCED CREATIVE FOCUSED
Innovations in Administration and Injection Systems EXPERIENCED CREATIVE FOCUSED Meeting Your Drug Administration Challenges Your injectable drug product will be perfectly pure when you ship it, but will
More informationManaging cost considerations and access to technology for cost effective vaccine manufacture in developing countries.
Managing cost considerations and access to technology for cost effective vaccine manufacture in developing countries. Amol R. Dindokar Serum Institute of India ltd. Overview Disease Control Priorities
More informationNo.1, Xianyao Road, Xianju, Zhejiang, China,
No.1, Xianyao Road, Xianju, Zhejiang, China, 317300 Xianju Pharma Outline Outline I. Brief Introduction II. Quality Unit III. Production System IV. EHS System I. Brief Introduction Xianju Pharma Zhejiang
More informationSELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS. Dr. Jay T. Holt, Ph.D., Sr. Director, Inhalation & Analytical
SELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS Dr. Jay T. Holt, Ph.D., Sr. Director, Inhalation & Analytical www.cirruspharm.com February 2014 INTRODUCTION Cirrus, a Kemwell company, is frequently
More informationDifferentiate your brand. with the unique look and performance of capsugel s press-fit and xpress-fit gelcaps. capsugel.com
Differentiate your brand with the unique look and performance of capsugel s press-fit and xpress-fit gelcaps capsugel.com Imagine the possibilities Breathe new life into existing product lines. Build your
More informationGUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V) OCTOBER 2003
EUROPN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulary framework and market authorisations Brussels, F2/AW D(2002)
More informationPRIME-XV Dendritic Cell Maturation CDM
PRIME-XV Dendritic Cell Maturation CDM Chemically defined, animal component-free medium for dendritic cell culture Optimized for differentiation of monocytes into immature dendritic cells (idcs) and subsequent
More informationCOMMENTS. Submitted by The International Pharmaceutical Aerosol Consortium
COMMENTS on a draft Guidance for Industry Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 99D-1454) Submitted by
More information905 UNIFORMITY OF DOSAGE UNITS
Change to read: 905 UNIFORMITY OF DOSAGE UNITS [ NOTE In this chapter, unit and dosage unit are synonymous. ] To ensure the consistency of dosage units, each unit in a batch should have a drug substance
More informationContinuous & Continued Process Verification. Presented by Eoin Hanley 4 July, 2016
Continuous & Continued Process Verification Presented by Eoin Hanley 4 July, 2016 This session will cover Quick recap on PV Lifecycle stages & Annex 15 Continued (Onoing) Process Verification Continuous
More informationSPS Pharma: Who we are?
Applications in area of drug release using the flow through cell Society of Pharmaceutical Dissolution Science 26-27th July 2016 Ahmedabad (India) Samir Haddouchi samir.haddouchi@sps-pharma.com www.sps-pharma.com
More informationRegulatory Support for Tobacco Products. Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help.
Regulatory Support for Tobacco Products Feeling daunted by the regulatory process for tobacco products? Don t worry Battelle can help. PREMARKET TOBACCO (PMTA) HUMAN FACTORS STUDIES SUBSTANTIAL EQUIVALENCE
More informationMedicinal Marihuana Science, Redefined
Medicinal Marihuana Science, Redefined From Concept to Commercialization.... www.avantirx.com WELL BEYOND COMPLIANCE Medicinal Marihuana Science, Redefined... ARA Avanti Rx Analytics Inc. is a Health Canada
More informationJoin in for Healthy Hands
Join in for Healthy Hands Healthy hands are vital to ensuring healthy lives. At Zep, we support healthy hands and strive to provide programs to keep your customers and workplace germ free. FUZion The Right
More informationTechnical Monograph n 17, 2nd Edition. Guidelines for Specifying the Shelf Life of Plant Protection Products
Technical Monograph n 17, 2nd Edition Guidelines for Specifying the Shelf Life of Plant Protection Products June 2009 TABLE OF CONTENTS 1. Introduction 3 2. Background 3 3. Definitions 4 4. Outline of
More informationFORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels
Seite 1 von 8 Share this story: Issue: April 2015, Posted Date: 3/30/2015 FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels INTRODUCTION Soft gelatin capsules (softgels) continue
More informationBEWITAL agri Your specialist in milk & fat Production of healthy, nutritional animal feed stuffs.
BEWITAL agri Your specialist in milk & fat Production of healthy, nutritional animal feed stuffs. EXPERTS DEPENDABILITY Creativity Quality Partnership SUSTAINABLE OPERATIONS SECURITY Responsibility trust
More information2018 INFUSE CALL FOR INNOVATION
2018 INFUSE CALL FOR INNOVATION Leveraging digital technologies for registration, identification, digital record-keeping and follow-up to ensure healthier futures Imagine a future in which all children
More informationPINOVA ESTER GUM 8BG STABILITY. SAFETY. SUSTAINABILITY.
STABILITY. SAFETY. SUSTAINABILITY. Trusted for over forty years, Pinova Ester Gum delivers reliable and effective emulsion stability. Ester Gum is used in an array of beverage types including sports drinks,
More informationSoluplus The Solid Solution Opening New Doors in Solubilization.
Soluplus The Solid Solution Opening New Doors in Solubilization. Dr. Shaukat Ali, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities. Custom Synthesis Excipients Active
More informationFood supplement manufacture
Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1 Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine
More informationThe Complete Program Provides:
CATALOG Pharmace is a suite of solutions dedicated exclusively to helping independent community pharmacies. Each program provides professionally created promotional resources and proven-effective nutritional
More informationGranulation SyStEmS For waxes & oleochemicals
Granulation SyStEmS For waxes & oleochemicals One solution for a wide range of applications and capacities 2 Granulation systems for waxes & oleochemicals Rotoform granulation for high quality, free-flowing
More informationWherever life takes you BASF excipients for orally disintegrating tablets make medication easy
Wherever life takes you BASF excipients for orally disintegrating tablets make medication easy Dr. Philipp Hebestreit, an enabler in excipients Pharma Ingredients & Services. Welcome to more opportunities.
More informationReview Article ISSN: Open Access. Regulatory Aspects of Pharmaceutical Excipients in India and their Qualification to Use in Pharmaceuticals
Review Article ISSN: 2581-4559 Open Access UPI JOURNAL OF BUSINESS MANAGEMENT AND COMPUTER APPLICATIONS Journal Home Page: https://uniquepubinternational.com/upi-journals/upi-journal-ofbusiness-management-and-computer-applications-upi-jbmca/
More informationUnderstanding Hemp Extracts and CBD Oil. Quality assurance, product selection, and serving size tracking.
Understanding Hemp Extracts and CBD Oil. Quality assurance, product selection, and serving size tracking. When selecting cannabis products, quality is the highest priority. Regulations in the hemp industry
More informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Venlafaxin ratiopharm Venlafaxin AbZ-Pharma Venlafaxin CT-Arzneimittel prolonged-release capsule hard venlafaxine hydrochloride DE/H/3393-3395/01-03/DC
More informationWE VE GOT THE POWDER THE KEY TO YOUR NEW MEDICATED CHEWING GUM
WE VE GOT THE POWDER THE KEY TO YOUR NEW MEDICATED CHEWING GUM Health in Gum is a powdered excipient specially designed to formulate and produce medicated chewing gum It combines gum base and sweeteners
More informationLakshy Management Consultant Pvt. Ltd.
What is ISO 13485:2003? You can t buy trust. BUILD IT through ISO 13485. Demonstrate your ability to supply medical devices through Quality Management System for Medical Devices - ISO 13485 ISO 13485 is
More informationDefoaming Surfactants
TERGITOL L Series Biodegradable Surfactants TERGITOL L-61 E, L-62 E, L-64 E, L-81 E Defoaming Surfactants Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow. These surfactants
More informationDesigned and manufactured specifically for pharmaceutical capsule filling
EXCIPIENTS Designed and manufactured specifically for pharmaceutical capsule filling Simple formulation Superior flow and weight uniformity Clean and efficient processing This document is valid at the
More informationInnovations in Design: NIA-West. Missy Lowery, MSc Head of Integrated Marketing Capsugel, now a Lonza company 11/13/2017
Innovations in Design: NIA-West Missy Lowery, MSc Head of Integrated Marketing Capsugel, now a Lonza company 11/13/2017 1 Innovations in Design: How Do You Stand Out? If all other competitors are the same
More informationCleaning validation. Presented by Marc Fini 21 May, 2013
Cleaning validation Presented by Marc Fini 21 May, 2013 What is cleaning validation? Cleaning validation is documented evidence that the cleaning process can effectively and reproducibility clean equipment
More informationMetered dose Alternative technologies
FACT SHEET 14 Aerosols UNEP Ozone Secretariat UNEP Ozone Secretariat Background Workshop Material for on HFC HFC Workshop, management: 2015 technical issues Bangkok, 20 and 21 April 2015 1. Description
More informationThe powdered, palm-free emulsifier for cake production
The powdered, palm-free emulsifier for cake production Palsgaard SA 6615 Sustainability is high on our agenda, too Responsibility is a key ingredient Your global partner in sustainable cake innovation
More informationDEVELOPMENT OF PLATFORM INJECTION DEVICES ADDRESSING HUMAN FACTORS AT AN EARLY STAGE FOR DIFFERENT USER GROUPS
DEVELOPMENT OF PLATFORM INJECTION DEVICES ADDRESSING HUMAN FACTORS AT AN EARLY STAGE FOR DIFFERENT USER GROUPS In this article Orfeo Niedermann, Business Development Director, and Jakob Lange, PhD, Account
More informationIT Foundation Application Map
IT Foundation Application Map IT vs. IS vs. CS IT = Information Technology CS = Computer Science IS = Information System IS Manage effective and efficient collaboration between CS and IT Industrial Engineering
More informationCurriculum Vitae. Lone Cleveland Andersen. Courses
Courses and continuing education, listed by subjects. GMP courses API Curriculum Vitae Lone Cleveland Andersen Courses ICH Q7; Compliance for API s manufactured by cell culturing and fermentation, European
More informationAlmirall grants Invida commercial rights for Aclidinium in Australia and New ZealandAlmirall????? (Invida)??????????? Aclidinium?????
Almirall grants Invida commercial rights for Aclidinium in Australia and New ZealandAlmirall????? (Invida)??????????? Aclidinium????? Almirall licenses Aclidinium to Invida in Australia and New Zealand
More informationIPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope
IPEC Europe Observations and Recommendations on Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human
More informationDry Powder Inhaler. Developing an Efficient. 3M Conix DPI. White Paper / Spring Proven Solutions that Enable Your Success
3M Drug Delivery Systems Developing an Efficient Dry Powder Inhaler 3M Conix DPI White Paper / Spring 2011 Proven Solutions that Enable Your Success Introduction introduction Inhalation drug delivery has
More informationLOGIQ E9 with XDclear
GE Healthcare LOGIQ E9 with XDclear Make every day extraordinary healthymagination GE imagination at work LOGIQ E9 with XDclear Today, LOGIQ* E9 with XDclear gives you a renewed freedom to use ultrasound
More informationStockpiling of H5N1 vaccines
Stockpiling of H5N1 vaccines Norbert W. Hehme EVM Influenza Pandemic Working Group EU-Commission Workshop on Stockpiling of Medicinal Products February 21/22, 2008 European Vaccine Manufacturers 1 (EVM)
More information