AARTI Industries, Booth Table 58 [ company website ]

Aarti Industries, Indian CMO with FDA-approved manufacturing site for APIs and Advance intermediates in India, We offer contract manufacturing services in dedicated anti-cancer block for phase-1 to final drug substance and offer custom manufacturing of advance intermediates for APIs and NCE development.

Aarti Industries pharma division founded in year 2000. Our headquarters is in mumbai and R&D centre 20km away from mumbai city.

Aarti has expertise in asymmetric hydrogenation, multi-step synthesis, implementation of enzymatic technology (green chemistry) and manufacturing of product in commercial flow reactor.

CMO infrastructure: 

WHO-GMP approved plant for APIs and Advance intermediates * (Total volume 34260 liters)

USFDA approved plant for Advance intermediates * (Total volume 317450 liters)

USFDA and EDQM approved plant for APIs* (Total volume 73220 liters)

1. One dedicated Anti cancer Block
2. One dedicated Cortico-Steroid Block
3. Two multipurpose Blocks

AMRI, Booth Table 18

AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product. The key contact is

Asymchem, Booth Table 11

Asymchem is one of the world’s leading global companies for producing pharmaceutical chemicals/API’s, providing integrated services that range from drug discovery to commercialization. With a workforce or over 1000 well-trained professionals and some of the most modern facilities in the world, Asymchem has supported many companies, large and small, at all stages of the pharmaceutical research and development chain.

Bellen Chemistry Co., Ltd., Booth Table 55 [ company website ]

BELLEN CHEMISTRY is an innovative CRO & CDMO company highly specialized in heterocycles and it owns a library of know-how for scale up of ca. 10,000 heterocyclic compounds. Bellen provides a range of high standard services, including Catalog, Custom Synthesis, FTE, Process R&D and Custom Manufacturing. These models are seamlessly interfaced as a powerful one-stop platform, which has helped our customers speed up their drug development on many projects and we are capable to deliver products at quantities from grams to tons to meet the precise requirements at different stages.

Chiral Technologies, Booth Table 44 [ company website ]

Chiral Technologies and Daicel Corporation have combined our talent and passion for delivering quality services and products to the pharmaceutical market and beyond. To support IND, DMF, and ANDA submissions, we now offer GMP Analytical Services, as well as catalog and custom Labeled Standards and Impurities. We continue to provide exceptional chiral chromatography products with the world’s largest portfolio of chiral stationary phases (CSP), manufactured reproducibly and reliably at our Daicel facility in Arai, Japan, and GMP custom chiral separation services, from mg to metric ton.

CordenPharma, Booth Table 103 [ company website ]

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids & Carbohydrates – Injectables - Highly Potent & Oncology - Small Molecules - Antibiotics - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value products.

Eurofins Alphora, Booth Table 8 [ company website ]

Eurofins Alphora provides API technology services for the scale-up of complex small molecule for pharmaceutical and biotechnology companies. We support IND and Commercial Readiness of APIs.

Alphora operates FDA inspected and approved facilities including cGMP manufacturing operations, organic chemistry PR&D and analytical laboratories supported by Quality Control/Quality Assurance functions. A separate high-potency suite completes Alphora’s 74,000ft² facilities.

A 3rd m

Evonik, Booth Table 3

Evonik, a global leader in specialty chemicals, provides API & intermediates manufacturing, drug delivery technologies, advanced food ingredients & amino acid derivatives. Core CMO activities encompass API/HPAPI chemistry & biotechnology with additional focus on advanced technologies such as fermentation & strain development, and highly pure mPEGs & PEGylations. CMO services for oral drug products as well as parenteral drug manufacturing & sterile filling are also offered.

Evonik's global API manufacturing network & technical expertise provides unique flexibility & problem-solving capabilities to meet the most demanding project requirements. As the global leader in HPAPI manufacturing, projects move seamlessly from lab through to commercial scale.

Farmhispania, Booth Table 75 [ company website ]

Farmhispania Group is a CDMO composed of two companies in Spain: Farmhispania (Barcelona) and Rolabo (Zaragoza). We provide PR&D/Custom manufacturing services of API/advanced intermediates and HPAPI's starting from Phase I clinical trials up to and including commercial supply. Our >60 scientists use the latest in technology and up to date DoE approach in a QbD framework. We provide our customers with a dedicated development and analytical team to support process/analytical development, TT and manufacture. Our core handling technologies include:

• HPAPI Technical Centre (OEL <30 ng/m3)
• HP Fermentation (OEL <0.1 ug/m3)
• Hydrogenation (20 bar)
• Cryogenics (-80 degrees C)
• Large scale preparative HPLC (various scale up to 300 mm diameter high pressure and 600 mm diameter medium pressure)
• Large scale medium pressure chromatography including IEC
• Large scale freeze drying
• Wet milling
• Micronisation

FLAMMA, Booth Table 1 [ company website ]

LAMMA is a CDMO with Headquarters near Milan, Italy. As a fully integrated CDMO, we can leverage our 100% self-owned, self-managed facilities, in Italy, China and the USA to deliver a stable, reliable supply chain. 

We specialize in the cGMP manufacturing of:

• APIs
• NCEs
• RSMs
• Advanced intermediates (NCEs and generics).

We use our expertise in high value chiral materials (specifically amino acid related materials) to provide solutions to customers who not only have need for chiral materials but also clients who have other requirements with a various type of chemistries. In addition, we also manufacture specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries, and we have a variety of niche generic products.

FLAMMA has four state of the art cGMP manufacturing facilities, each with its own R&D staff and labs.

Italy

1. Flamma Chignolo has 120 m³ capacity
2. Flamma Isso has 130 m³ capacity

China

1. Flamma Honkai is located outside of Dalian, China with 200 m³ of capacity

-   Flamma Honkai provides the security of constant Italian management & oversight. It is like having an Italian facility in China.

USA

1. Flamma USA is located in Malvern, PA outside of Philadelphia

- Flamma-delpia features a cGMP Pilot Plant, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite, 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or  warehouse needs.

Flamma works on both early stage pre-clinical development of small molecules (grams to multi-kilo) as well as large-scale commercial manufacturing (MT). With over 600 employees and a total capacity of 450 m3 and the flexibility to use three different manufacturing sites and four different R&D labs, see why Flamma is the “go to” contract manufacturer of the pharma industry. Experience the FLAMMA difference today!

Helsinn, Booth Table 2

Helsinn is a leading Swiss CMO located in Biasca, Switzerland with over 30 years of experience in chemical development and cGMP manufacturing. Helsinn serves small to large biotech and pharmaceutical clients, supporting analytical and process development, manufacturing scale-up, optimization, registration and validation for mid to late stage clinical and commercial compounds. While focusing on synthetic NCEs, Helsinn performs a wide variety of services and chemical syntheses (see those called out below

J-Star Research, Booth Table 62

Johnson Matthey, Booth Table 79

At JM, we turn science into customer solutions. We take our knowledge of chemistry and materials and use it to solve your complex problems, whether that is scaling up manufacturing or developing new and next generation products. Our areas of expertise include controlled substances, custom pharma solutions, catalysts, and APIs and life cycle management.

Kingchem, Booth Table 31 [ company website ]

Kingchem Life Science's R&D, manufacturing, logistics and sales facilities in the USA and China provide competitive advantage, supply chain assurance and excellence in customer service.

For regulatory starting materials, advanced intermediates or custom APIs, let our technically proficient teams tailor a solution to your needs with our competitively positioned contract research, process development, chemical synthesis and custom manufacturing.

We offer core technologies in fluorination, chlorination, hydrogenation, organometallic reactions, heterocyclic compounds and chiral compounds with wide-ranging chemical capabilities enabling the large scale production of complex organic compounds.

From kilograms to multi-tons, leverage Western management and Eastern value by making Kingchem your solution for reliable custom manufacturing.

Mercachem Syncom Group, Booth Table 19

Mercachem is a privately owned leading European contract research organization offering innovative exploratory chemistry, medicinal chemistry and process R&D services to accelerate the drug discovery and development process in a flexible and cost-effective way. Mercachem was founded in 1997, occupies 3,500 m2 state-of-the-art research facilities in Nijmegen, the Netherlands, and employs more than 100 chemists. Working for many pharmaceutical and biotech companies throughout the world, Mercachem is r

MRIGlobal, Booth Table 88

At MRIGlobal, our focus in Pharmaceutical Sciences is providing clients with scientifically driven results to keep projects on track. Our 80 years of success is built on a strong foundation of technical competence, communication, quality, and teamwork. Together, we achieve your objectives, continually assessing your parameters and goals.

Novasep, Booth Table 61

Novasep provides flexible contract development & manufacturing (CDMO) solutions for Small Molecule APIs & Biopharmaceuticals to innovators. We offer a wide range of flexible cGMP manufacturing assets on multiple sites with an outstanding regulatory track record.

We are a world leader in a number of technologies including industrial chromatography (batch and continuous), hazardous & cryogenic chemistry, HPAPIs, ADCs & Viral Vectors.  

Novasep has recently invested over >100m€ to expand its commercial manufacturing footprint including:

> ADCs: A new 11m€ bioconjugation unit in Le Mans, France

> Viral Vectors: Senrise-IV, a new 27m€ facility for AAV, Adenovirus, Lentiviral vectors, HSV... in Seneffe, Belgium

> Fill & Finish: Senefill, a new 10m€ facility for aseptic Fill & Finish operations for viral vectors, viruses, plasmids and other biologics in Seneffe, Belgium

Have a look at our website to learn more about our services: www.novasep.com

And to contact us: novasep@novasep.com

Olon SpA, Booth Table 23

Olon Ricerca Bioscience, a member of the Olon Group, is a contract research and manufacturing organization offering first-class analytical chemistry, synthetic chemistry, engineering and API manufacturing services throughout all phases of drug development. Our highly experienced scientific team has a proven history of achievement with complex chemistry challenges providing a complete solution for your small molecule chemical development needs, creating a synergy that excels at first?time scale?ups and subsequent development of safe, reliable, robust and cost-effective manufacturing processes. Together, our facility in Concord, Ohio, (ranging from 22 to 3,000 liters) contains state of the art analytical instrumentation, kilo labs and pilot plant reactors and our 8 FDA-inspected manufacturing plants in Europe (totaling more than 5,000 m3 of capacity), provides access to multipurpose HPAPI Labs for either cytotoxic and non-cytotoxic APIs and to high capacity fermentation plant.

From preclinical development to commercial manufacturing, Olon Group offers flexible access to a broad spectrum of development and manufacturing expertise.

Orion Contract Manufacturing, Booth Table 9 [ company website ]

Orion Contract Orion Contract Manufacturing Manufacturing offers wide drug substance and drug product contract development and manufacturing services within the Finland-based Orion Corporation, founded in 1917.

Orion Contract Manufacturing want's to offer fully integrated contract development and manufacturing services from phase I to commercial scale for GMP Intermediates and API's. Orion has high expertise in development of intermediates and API's for NCE products and has API development projects constantly in clinical phases I-III. All Orion API sites are FDA/EMA approved and high quality best in class automated sites.

Orion Contract Manufacturing has also wide drug product contract manufacturing offering. We have for example following services available:  highly potent and cytotoxic tablets and capsules, dedicated facility for semisolid hormones, narcotics & controlled substances, topical creams, gels & ointments, oral tablets & capsules, nasals, sprays, liquids & suspensions, small volume sterile, veterinary products, prefilled oral syringes and packaging operations with serialization capabilities.

Orion corporation is also interested in out- and in-licensing opportunities for NCE products.

Raffles PharmaTech, Booth Table 91 [ company website ]

Raffles provides small molecules to support the discovery, development and launch of innovative medicines. Our custom synthesis services (CSS) group provides scaffolds and libraries of unique compounds for supporting drug discovery efforts.

Our development teams are involved in process development and manufacturing of key starting materials and intermediates for clinical studies and commercial supply. Specialties include chiral compounds, sulfur containing molecules, amino acid derivatives and heterocycles with difficult substitution patterns.

We are based in Guangdong, China, where we operate 45,000 sq. ft of modern, well-equipped lab and production facilities.

Solvias, Booth Table 5 [ company website ]

Solvias is a privately held company located in Basel/Switzerland. With over 300 highly qualified employees, Solvias supports the research and development of new drug substances and the optimization of manufacturing processes for pharmaceutical, biotechnology and life science companies worldwide. Customers benefit from a wide range of experience in the following areas: Chemical Development and cGMP Manufacturing , Catalysis, Analytical Services, Process analytical technologies and, Polymorphism, salts an

W.R. Grace, Booth Table 92

Grace, built on talent, technology and trust, is a premier specialty chemicals company that provides innovative technologies and services to help solve complex challenges in custom chemical synthesis and the scale up of fine chemicals for the pharmaceutical, nutraceutical, food and beverage, chemical processing, and other industries.

Grace works with customers to support projects from pre-clinical through commercialization, offering customized product development, project management, and scal

WeylChem InnoTec GmbH, Booth Table 28 [ company website ]

Innovating chemistry. Together.

WeylChem InnoTec, based in Frankfurt, Germany is the innovative partner to the fine chemical, pharmaceutical and electronics industry. With competencies in Analytics, Contract Research, and Custom Synthesis, we are your agile development partner.

We developed a strong expertise in organometallic and low-temperature reactions down to -100 °C. Another core competency are high-pressure reactions like carbonylations, hydroformylations, and specialty hydrogenations up to 200 bar.

We combines these challenging technologies in multi-step-syntheses with the whole range of modern organic chemistry using state-of-the-art, multipurpose facilities with a 80 different stirred reaction vessels with capacities ranging from 100 to 5,000 liters.

Contact information:

Richard Amitrano
VP Business Development North America
Industriepark Höchst G 830, 65926 Frankfurt am Main, Germany
Phone: 718-948-4604
Mobil: 917-612-0795
ramitrano@raaassociates.com

Wilmington PharmaTech, Booth Table 52

Wilmington PharmaTech Company (WPT) is a leading global service company specializing in research and development of process chemistry and medicinal chemistry for the pharmaceutical and biotechnology industries. Founded in 2003 in Newark DE, WPT has a proven track record of providing fast, reliable and quality services for pharma and biotech companies worldwide. In addition to the five cGMP kilo labs we have in Newark DE, we recently acquired a pilot plant location which will enable us to further expand

Zach System, Booth Table 15

Zach System, FDA inspected site located in France, excellent track record. API manufacturer including corticosteroids, special excipients, RSM. Handling API with OEL 1 µg / m3 — OEB 4. R&D team (20 people), Kilolab, Pilot Plant. Special technologies: Hydride Reduction, Lithiation, Cryogenic Reaction, Birch, Diels-Alder, Ozonolysis, Grignard. Hydrogenation: 400L, 1000L (5 bars), 2*4000L (12 bars).Special handling: LAH, DMS, DES, Acetylene, KCN, NaCN, Li or Na in liq. Ammonia, AIBN. Speci