POCKET GUIDE
MARCH 18-21, 2019 NEW YORK CITY
Manufacturing cGMP API
and Intermediates utilizing our
Continuous Processing, High Containment, Controlled Substance, Energetic Chemistry and Simulated Moving Bed expertise for pharmaceutical companies globally. World leaders in the development and commercialization of Continuous Flow Processing. Our manufacturing facilities are home to commercially approved products for several of the world's most innovative pharmaceutical companies. • A talented workforce of 1,285 people strong • Over 1000m3 state-of-the-art manufacturing facilities • 75 years of expertise in the manufacture of API and intermediates • 6 manufacturing sites • Global footprint across 3 continents • Manufacture API and intermediates from grams to multi-tons • Multiple service offerings • 2 companies joining forces to create substantial market synergies • 1 name in the future of contract manufacturing
SKBT business meeting space
AMPAC business meeting space
Intercontinental Barclay Suite 623 & 637
Marriott East Side Astor I & II
Korea
Ireland USA
www.skbiotek.com ampacfinechemicals.com skbiotekmarketing@sk.com afcbusdev@apfc.com �AMPAC
(_J, FINECHEMICALS
Lotte New York Palace Hotel, Chairman’s office – 5th floor, suite #1401, #1402, #1426
CREATING VALUE FOR OUR PARTNERS SINCE 1973 • Active Pharmaceutical Ingredients • Electronic Filing in CTD Format Direct to FDA • Pharmaceutical Machinery • Generic Pharmaceutical Products ACIC leverages our trusted network of world-class research and manufacturing facilities with our extensive regulatory and project management capabilities in order to advance your project from molecule to market. www.acic.com
At the InterContinental New York Barclay, Suite 1450
METHAPHARM YOUR STRATEGIC PARTNER HOSPITAL & SPECIALTY PRODUCTS • Access to Markets in the USA & Canada • Over Twenty Years of Experience • Comprehensive Capabilities Part of the ACIC Group, Methapharm is focused on the acquisition, licensing, and commercialization of hospital or specialty pharmaceutical products as well as products in the fields of respiratory and medical imaging. www.methapharm.com
Stop by today & see what we are all about. Visit us at the InterContinental New York Barclay Meeting Room 518
Since 1981, Interchem Corporation, A Pharmasphere Company, has been successfully locating sources of active pharmaceutical ingredients, fine chemicals, intermediates, and sophisticated next generation compounds from all over the world. With global capabilities, we are able to bring together materials and producers to supply any product. By combining the expansive range of chemistries at our disposal with our in-house technical and regulatory expertise, we are able to handle your diverse requirements. Our tracking system ensures high customer service levels at all times. Interchem prides itself on supplying a service that brings professional sourcing with contracting, as well as technical and regulatory support. Stop by the New York Barclay Meeting Room 518 for more information on what we can do for you or perphaps what you can do for us.
120 ROUTE 17 N. PARAMUS, NJ 076 5 2 T: 201 . 261. 7333 SALES@INTERCHEM.COM • WWW.INTERCHEM.COM
Tangram Company, LLC America’s Producer of High Purity Inorganics
Carbonates Phosphates Sulfates Custom
Tangram Company, LLC America’s Provider of High Quality Services
Blending Granulating Grinding/Fine Grinding Drying Roller Compaction cGMP Quality System FDA Registered Manufacturing Facility
Tangram Company, LLC 125 Corporate Drive Holtsville, NY 11742 Phone: 631-758-0460 Fax: 631-758-0471 E-mail: tangramco@aol.com Web Site: www.tangramco.com
fine chemistry
• APIs AND INTERMEDIATES • FINISHED DOSAGE FORMS • REGULATORY EXPERTISE • SCIENTIFIC PROFICIENCY
Since 1975, Flavine continues to be your global partner for all of your sourcing needs, supporting all delivery forms for both human and animal health industries. With our vast resources and regulatory expertise, we connect our customers and manufacturers to achieve the fastest possible market entries. • More than 250 successful USFDA and EDQM inspections • Over 250 APIs and Intermediates • Offering 50 Finished Dosage Forms • Ubiquitous market presence with five offices worldwide D C AT W E E K ‘ 1 9 InterContinental New York Barclay Hotel Meeting Rooms 408 | 409 | 410
Flavine North America, Inc. 10 Reuten Drive Closter, NJ 07624 USA Tel: (+1) 201-768-4190 flavine-northamerica@flavine.com
Affiliated Flavine Companies Flavine Europe GmbH Munich, Germany (+49) 89-939967-0 flavine-europe@flavine.de
Flavine Shanghai Co., Ltd. Shanghai, China (+86) 021-38920830 flavine-china@flavine.cn
Flavine India Ahmedabad, India (+91) 79-40009449 flavine-india@flavine.com
Flavine Pharma France SA Marseille, France (+33) 970-448-219 flavine-france@flavine.com
www.flavine.com
Strong Enough to
Meet Your Needs Gyma is a global network of leading pharmaceutical companies For over 60 years, our customers have trusted our team of experts for their delivery, development, research and manufacturing needs. We have you covered from A-Z. Learn more at www.gyma.com
Follow us on LinkedIn
development
your molecule has so much potential. our passion for development will help unlock it.
As the #1 global leader in drug development, Catalent’s comprehensive capabilities, integrated network, robust scientific approach, and deep dose design expertise provides innovators with a more complete and integrated spray drying solution to accelerate development from clinical to commercial supply.
Catalent. More products. Better treatments. Reliably supplied.™ us + 1 888 SOLUTION (765-8846) eu 00800 8855 6178 catalent.com/optiform Š 2019 Catalent Pharma Solutions. All rights reserved.
The Perfect Form
M A K E S
F O R
P E A K
Performance The finish line is different for every project, but the right CDMO can get you there quickly, safely, and efficiently by minimizing the pit stops along the way. Too big and they may be slow to respond. Too small, they may not be able to keep your project on track. TEDOR is the right size CDMO for your next project. Contract development and manufacturing is all we do. Our promise is simple: your project is our only priority, your satisfaction our only concern.
T H E
R I G H T
S I Z E
C D M O
W W W . T E D O R P H A R M A . C O M
Refreshingly Adaptable CDMO
BioVectra offers contract development and manufacturing capacity for intermediates and APIs from four North American GMP facilities. We have over 45 years of experience, specializing in: Microbial Fermentation Complex Chemistry – High Potency APIs Biologics Formulation Development
For more information please visit us at www.biovectra.com, or contact us at info@biovectra.com
866-883-2872 BioVectra Inc. 902-566-9116 11 Aviation Avenue 902-628-2045 Charlottetown, PE C1E 0A1 BVI-HR@biovectra.com ioVectra Inc.
1 Aviation Avenue harlottetown, PE 1E 0A1
www.biovectra.com 866-883-2872
When it comes to outsourcing focused on commercial success, you need a CMO that has been there many times through deep scientific expertise and world-class facilities.
EXPERIENCE UNRIVALED Contract Manufacturing Biologics | ADCs | Potent | Drug Product | Fermentation Prefilled Syringe | Hot Melt Extrusion | APIs abbviecontractmfg.com
Advitech, a Swiss boutique advisory firm focused on Healthcare and Fine Chemical Industry, is proud to announce the launch of:
A collection of Reports offering an original information tool to the APIs business community. After the first study on APIs trends, “CDMO Benchmarking Report Baseline Analysis”, the new issue “CDMO Benchmarking Report 2017/2018” will be available by June 2019.
www.advitechswiss.com apistrends.advitechswiss.com
PEPTIDE GENERIC APIs BACHEM Bachem is the leading independent supplier of active pharmaceutical ingredients (APIs) for the human and veterinary pharmaceutical market. • Octreotide Acetate • Glucagon • Atosiban • Goserelin Acetate • Lanreotide • Leuprolide Acetate • Tetracosactide • (Arg8)-Vasopressin • Triptorelin Acetate • Teriparatide Acetate • Icatibant Acetate
www.bachem.com
MEET US AT DCAT WEEK MARCH 18–21, 2019 OMNI BERKSHIRE PLACE/MADISON SUITE 1212
Premium Pharmaceutical Ingredients
Bulk GMP Buffers
Made in the USA
Contract GMP Manufacturing
Made in the USA
Custom API Development
Made in the USA
Exclusively manufactured in the USA in our FDA registered & inspected GMP facilities VISIT US AT
Lotte Palace, Suite 1203 455 Madison Ave | New York | NY | 10022
For an Appointment Contact:
Paul DiMarco | Vice President +1.610.422.0341 | pdimarco@biospectra.us
Y
QU
Meet us at the Kimberly Hotel
A LIT
A I L E B
Y T E F A S
LE
R Geared for Success Like a well-oiled machine, we produce only the best in Boranes, Alkali Metal Alkoxides and HMDS Bases because quality should never be compromised.
Choose the proven leader. Choose Callery.
www.callery.com info@callery.com | +1.724.538.1200
Route Finding Process Development Analytical Development GMP Scale-up API Manufacturing
The Lexington New York, Suite no 2015 www.dottikon.com
WELCOME TO DCAT WEEK 2019
PROOF IN EVERY PRODUCT
As a leading contract development and manufacturing organization, DPT, a Mylan company, is recognized for its expertise in semi-solid and liquid dosage forms. From pre-formulation to commercial manufacturing, you only need one partner to streamline your path from lab to market: DPT does it all.
SERVICES AND CAPABILITIES FULL-SERVICE DEVELOPMENT • PRE-FORMULATION AND FORMULATION • ANALYTICAL DEVELOPMENT AND VALIDATION • PROCESS DEVELOPMENT AND VALIDATION • STABILITY STUDIES: ICH AND CUSTOM • CLINICAL TRIAL MATERIAL MANUFACTURING • IN VITRO RELEASE TESTING EXPERTISE • REGULATORY SUBMISSION SUPPORT • QUALITY-BY-DESIGN (QbD)
DOSAGE FORMS • AEROSOLS • CREAMS • EMULSIONS • EXTRUSIONS • GELS
• LOTIONS • OINTMENTS • SOLUTIONS • SUSPENSIONS
SPECIALIZED CAPABILITIES • AQUEOUS XP SOLVENTS • CYTOTOXIC • HORMONES
1-866-CALL-DPT (1-866-225-5378) | DPTLabs.com
LET US TAKE YOU FURTHER, FASTER. DSM is the world’s largest manufacturer of vitamin, carotenoid, and lipid APIs with over 70 years of experience in pharmaceutical applications.
ACHIEVE
Global regulatory support from the only supplier WITH DSM with access to US DMFs and CEPs for all 13 essential vitamins
RELY
GMP-qualified global manufacturing ON DSM network for sustainable, long-term supply
INNOVATE
Broad R&D capabilities to support WITH DSM development across the product life cycle
Find out how we can help you. Visit: www.dsm-pharmasolutions.com
CDMO FOR
COMPLEX FORMULATIONS
We take pegylated & LNP drug product formulations from clinical development to commercial distribution ExeleadBioPharma.com
API CONTRACT DEVELOPMENT & MANUFACTURING SERVICES ■ ■ ■ ■ ■
Clinical and Commercial phase From Kg up to multiple Tons NDA and ANDA filings All sites FDA, ANSM/BfArM, PDM, regularly inspected 40 M€ ongoing investment
3 SITES COMMITED TO MANUFACTURING EXCELLENCE EXCELLA - Germany
VALDEPHARM - France
FAREVA La Vallée - France
SPECIAL CAPABILITIES ■ HPAPI & CYTOTOXICS: 2 sites with Small & Large scale volumes OEB 4, 5 & 6 Safebridge® Certification
■ Aseptic Crystallization & Micronization ■ Spray Drying
EXPANDING
EXPANDING
COMING SOON
■ Large Scale Manufacturing, including Wet Milling, High Pressure Hydrogenation, Micronization
■ Steroids, Hormones & Controlled Substances
New York March 18-21, 2019
San Diego October 16, 2019
Chicago April 30-May 2, 2019
June 19-20, 2019
Long Branch September 16-18, 2019
Frankfurt November 5-7, 2019
ghlass.usa@fareva.com / www.fareva.com
Going further to bring better todays to even more people with cancer
At Helsinn Advanced Synthesis SA, Biasca, Switzerland, we offer our partners the highest quality standards and up-to-date technologies for the manufacturing of APIs, HPAPIs and Anticancer compounds. Through our know-how, R&D expertise and solid CMC approach, we are the right late stage partner for registration, validation and commercial manufacturing.
www.Helsinn.com
Our complex chemistry helps you create life-changing results We work globally with our pharmaceutical customers to deliver complex chemistry solutions for a healthier world. We produce sophisticated APIs for life-changing drugs; our expertise in controlled substances helps combat chronic pain and we employ decades of catalysis knowhow to enable faster, cleaner and more efficient reactions. Our custom pharma solutions offering and worldwide manufacturing capabilities help to get your drugs to market faster, making a real difference to the quality of life.
To find out more visit matthey.com or email pharma@matthey.com
A world-class manufacturer
of aluminum tubes, laminate tubes & aerosol cans Serving the pharma market for more than 60 years
- Drug Master File - Unit dose options - Child resistant closures - Statistical Process Control - Vision inspection systems - Proven shelf life - Recyclable - GMI Certified -
Ask our North American Sales and Marketing for Samples or Pricing! 1-866-622-5124 | www.montebellopkg.com | sales@montebellopkg.com
Fill & Finish CDMO For High Potent & Cyto Injectables > Flexibility & Reliability > Small Molecules APIs & Biomolecules > Clinical & Commercial Supplies > Full Service – Development to Packaging > State of the Art Facility for Liquid and Lyo – Single-Use System Technology – Aseptic Isolator Filling > Complex Formulations – Organic Solvents Handling & Freeze-Drying – Temperature, Oxygen & Light Sensitive
POLAND
GERMANY
CZECH REPUBLIC FRANCE
www.oncomed.cz
vCard
oncomed manufacturing a. s. Karásek 2229/1b, 621 00 Brno, Czech Republic, EU bd@oncomed.cz, phone +420 602 435 374
AUSTRIA
Contract Manufacturing
Hormonal semi-solids, solutions Ointments, creams, gels Nasal sprays, liquids, suspensions Tablets & capsules, including cytotoxics & high-potent Injectable vials & ampoules Packaging and serialization Veterinary medicines API synthesis and process development Large scale commercial API contract manufacturing HPAPI development and manufacturing from grams to multi-ton scale EMA/FDA/JP/ANVISA compliance
Visit us at suite 415 in InterContinental Barclay during the DCAT week ‘19
YOU CAN RELY ON US mailto: cmo@orionpharma.com www.orion-cmo.fi • www.fermion.fi
GROUP
An ABF Ingredients Company
Your Partner in Formulation
Toll Free: 1.844.476.8200 Email: info@sst-corp.com
T: 1.973.473.4300
F: 1.973.473.4326
SST HEADQUARTERS AND DISTRIBUTION CENTER
635 Brighton Road, Clifton, NJ 07012
www.sst-corp.com
Global link in pharmaceutical manufacturing for over 65 years
FROM CONCEPT TO COMMERCIAL FOR SOLID DOSE & SEMI-SOLIDS UPM Pharmaceuticals is an independent, award-winning CDMO. We offer development and manufacturing of tablets, capsules and semi-solid dosage forms – including DEA controlled substances (CII–CV) and a controlled humidity suite. At our 476,000 sq ft facility in Bristol, Tennessee, our experienced personnel can advance your project from lab scale to commercial in a single location. Trust your project to the client-focused team at UPM.
Visit UPM Pharmaceuticals at DCAT Week ‘19 InterContinental Suite #537
TABLETS | CAPSULES | CREAMS & OINTMENTS
To learn more, visit www.upm-inc.com or call +1 423 989 8000