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What is API Development?

For ContractAPI Development services, Active pharmaceutical ingredient (API), is theterm used to refer to the biologically active component of a drug product (e.g.tablet, capsule). Drug products are usually composed of several components.

 

The aforementioned API is the primaryingredient. Other ingredients are commonly known as "excipients" andthese substances are always required to be biologically safe, often making up avariable fraction of the drug product.

 

The procedure for optimizing andcompositing this mixture of components used in the drug is known as"formulation". For example, if the API is a solid and the drug isrequired to have a liquid dosage form, such as a cough syrup, then theexcipients would be the liquids that are used to formulate the syrup.

 

The Photochemistry services designcriteria for any small molecule API is usually a combination of several factorsthat goes beyond the intended therapeutic effect, and usually heavilyencompasses both pharmacokinetic and pharmacodynamic considerations, so forthis reason, API molecules have many chemical functional groups.

 

The API form API Process Development thatis used in a formulation is often the most Phosgenation services thermodynamicallystable crystalline form. As such, the phenomenon of hydrogen bonding incombination with there being many functional groups on the API usually resultsin the available crystalline form being a hydrate.

 

Themission of an API Development CDMOis to provide complete services in chemical, process & analytical R&D,up-scaling & production improvement. With the help of a broad technologyplatform & lifecycle management experience, a notable API development andR&D team takes product to the next level with Top Cold Chemistry services partner.

 

Similarly,a API development GMP certifiedfacility with High Potent R&D department main functions include syntheticresearch and process development; analytical research and development;continuous improvement.

 

Choosean API Development and Manufacture CDMOwhose priority lies in the development of chemical procedures which aresubsequently used in the making of products sold not only on Czech markets, butmore importantly abroad.

Findthe information on APIProcess Safety Assessment services to get in touch with an API Development and Manufacture oriented State-of-the-art R&Dcenter with highly qualified professionals working in product development,analytical development and intellectual property rights.

 

What processes for GMP for APIspractically applied?

 

Duringearly process development, cGMP APIdevelopment expert will be able to conduct a safety evaluation to identifypotential issues during scale-up Protein API development Services. At that stage and based on itsfurther evaluation, the API redesign with BiocatalysisCDMOs facilitates processes to address all potentially hazardous issues.

 

Alongwith Separation & Purification, Thereare Cold Chemistry servicesspecialized in the development and the manufacturing of biologically activepeptides and complex organic molecules as API Protein development services and as innovative biochemical forresearch purposes including Peptidedevelopment services.

 

Itis important to know the internalities of GMPfor APIs practically applied in APIdeveloping companies which specialize in manufacturing, supplying, andcustom synthesis latest chemicals. Peptidecustom synthesis services cover all kinds of pharmaceuticals and treatments.

 

Fine Chemical / Intermediate offers an end-to-endpartnership for custom API development, scale-up and manufacturing Protein CDMO services with aflexible multipurpose EU GMP Pilot Plant, custom protein development services fromgrams to tonnes, with a client centric approach up to Spray Drying services.

 

Thefour most common out-of-scope project costs depends on API Development CDMO with emphasis on Development Cost and Raw Materials and Custom Synthesis CDMO.

 

There’s a cGMP API drug product development service for Active Pharmaceutical Ingredients and the same is true for budgeting. Numerous factors come into play in almost every project, and at every stage of the project. Always, there are unknowns. That’s why quoting in intermediatesdevelopment services CDMO business is an educated guess at best.  At worst, it’s a disingenuous ploy to make the project price seem more competitive than it will ultimately turn out to be.

 

In previous Reference Standards CDMOs, we’ve discussed at greater length some of reasons project costs could escalate.

 

Customprotein CDMOs will focus on the four most commonreasons for out-of-scope charges that may require additional funding. High Pressure Reactions CDMOs arefrequent source of cost overruns is add-ons by Crystallization Process services. As the chemistry for an API Spray Drying services develops, and if it looks promising, it’s not unusual for a Peptide APIs service providers sponsorto decide to invest more in the asset for several reasons.

 

One is that the Distillation / Liquid APIs R&D yields additional results with Halogenation services to unlock more value than initially expected. Another Crystallization Process services is to have a better shot atlicensing to a big pharma. A potential licenser may not want to spend another1.5 or two years developing an API. A cGMPAPI drug product development CDMO expects the High Potency APIs development service to enhance the value of theasset ahead of any licensing conversations.

 

HydrogenationCDMOs have seen plenty of situations where APIProcess Safety Assessment services andHigh Pressure Reactions CDMOs have invested the time and effort in a drugcandidate and were rewarded.  If High Pressure Reactions CDMOs have donea good job of de-risking the APIHalogenation services, which Micronizationservices usually recommend, for PeptideAPIs development in big pharmawill know they can have a secure and reliable supply chain, a key decisionpoint in their Scale-Up Capabilities.In those cases, the conversation moves more quickly from which Hydrogenation CDMOs is worth to alicensing discussion. Indeed, investing in a promising asset pays Custom protein CDMOs with increasedquality assurance.

 

Conversely, Ozonolysis services are required pharmaceutical companies walk awayfrom licensing less developed assets.  IfLow temperature service providers deem the risk of having to spendsignificantly more time and effort to develop the API for clinical trials, it’s usually interested in Route Evaluation & Development.

 

HazardousRaw materials

Thequality of the raw materials used in any APIdevelopment project are important building blocks.  We use numerous reliable sources for rawmaterials. But even with the most diligent sourcing Route scouting development and the close alliances, Peptide APIs CDMOs maintain withtrusted Route scouting services suppliers,there are many RadiolabelledCompoundsthat may be handled during APIdevelopment.

Asin other RouteEvaluation & Development requirements on the topic of raw materials, Reference Standards CDMOs should not unacceptable foreignmatter in the raw materials. Or when we test batches before accepting andstocking them, Cryogenic Conditions CDMOs can determinethe level of impurities exceeds the amounts specified in our GMP protocols.Those are both non-starters. Routescouting service providers would have to find higher quality or differentraw materials that may be costlier before the project can move forward.

 

Otherraw material issues also can add cost to an API project. The evolving chemistrymay dictate that we use more of a raw material to reach a desired yield, forexample.

 

Howmuch to set aside for API route scoutingCDMOs costs?

The rule of thumb for doing a home kitchen renovation project is to expect to spend 30% more than you budgeted. Likewise, there’s a rule of thumb for out-of-scope items in API development projects. Prepare to spend an additional 15-20%.

 

Theamount varies from project to project of course and may not be needed, but setaside the funds to be prepared if additional funding is needed. Developing newchemistry for every API project is a complex and time-consuming endeavor.Although some Peptide CDMO servicesprojects do go smoothly, most require either more analytical work or issues areencountered somewhere along the line that must be resolved.

 

If a big pharmaceutical company does become interested in that promising asset, you don’t want them to walk out the door because the analytical work was incomplete or the project wasn’t far enough along in its development.

 

Whereare the extra costs incurred in APIRoute evaluation services?

There are several different stages at which additional costs could materialize—in R&D, in analytical work, and in manufacturing.

 

At CDMO Service Providers or CDMOswith API development capabilities, API CDMOs tend to be conservative onthe time it takes to do detailed analytical work and inevitably Organometallic Chemistry Services are asked to pare that backsome. But most often API development service providersup adding CustomAPIs back in, as it’s what the pharma companies and the regulators will be looking closely at API development capabilities.

 

Whenthe focus on API Process optimization from thebeginning, API development coststend to be lower overall.  The work on Custom APIs gets done more efficientlyand the work is completed with a high level of quality

APIseparation CDMO service providers know no one wants to spend more money than necessaryand Micronization CDMOs are veryproactive in looking for money-saving solutions. Scale Up CDMOs For example, in one API purification service providers polymer projects thesubstance was being made in less than ideal conditions. The API development services sponsor wanted a 2nd, GMP compliant API purification CDMO services source. However, thecost-benefit analysis Low temperature service providersdid showed the costs would be too high, and Impurity CDMOsare recommended against a secondary source along with Protein purificationCDMOs. It would have required a great deal more time and exceeded the asset’s value for Protein purification CDMOs

 

APIRoute development services at the Highest QualityStandards

Therule of thumb is that most APIdevelopment projects will cost 15-20% more than budgeted due toout-of-scope project costs and addendums. Until a Scale Up developmentservices project is well under way, it’s hard to know with new chemistry of Scale Up development services whetherprocesses will change, requiring additional analytical work, or if the currentraw materials will suffice. Putting the additional funding aside de-risksprojects for API scale up development, assuring theywill be completed to the specifications required by big pharma and regulators.

 

API Development and Manufacture – Early Phase

Protein Separation CDMO services and Peptide CDMOs ensure that they have significant experience in thefirst time Scale-UpCapabilitiesof APIs. Starting with the medicinal chemistry route, our knowledgeablechemists can quickly identify the most pressing parts of the chemistry todevelop.

 

API Development and Manufacture – Late Phase

 

Supporting Late Phase API Development andCommercial Launch

Wehave an established reputation for developing processes for late clinicalstage. Top High Pressure Reactions CDMOs extensive experience lies intaking custom peptide service providers processesfrom inception through to process validation, both in small molecule chemistryand peptides, custom peptide services.As an API moves from early clinical phase towards late clinical phase, theemphasis of the project changes. Whereas in early clinical supply, a leanfit-for-purpose approach is appropriate, other factors start to dominate whenmoving towards late phase, particularly process efficiency and knowledge.

 

OrganometallicCDMOs and Fine Chemical / Intermediate API Development and Manufacture strategicallyintegrate Custom API development processes with the principles fromregulatory guidelines (FDA, ICH, USP), such as risk management and quality bydesign, as a basis for development and manufacturing strategies.

The high quality API development GMP certified CDMO has the strength in API development and manufacture isproven by being the Custom APIdevelopment partner of choice for many pharma and biotech companies seekingintegrated drug development solutions from molecule to market.

 

The technical expertise and extensivefacilities of Micronization services enableoffer integrated API contractmanufacturing solutions through all stages of the drug developmentlifecycle.  Custom API CDMOs are fully supported by dedicated analytical andregulatory teams along with MicrowaveChemistry Services.

 

In addition, API Development and Manufacture with Ozonolysis services offer numerous support capabilities, including:rapid implementation of chromatography for purification, containment equipmentfor potent compounds and Micronizationservices to control particle size.  Adynamic team of Fine chemicals CDMOservices successfully address many complex project challenges, andimplementing our on-site biocatalysis technology expertise is one example ofour responsive solutions.

 

Project management is critical for the effective execution and delivery of our customers’ complex projects.  HPAPIsdevelopment services have project managers are Fine chemicals development experienced scientists, HPAPIs CDMOs working with clients toanticipate and respond to project priorities.

 

APIDevelopment and Manufacture with Ozonolysis services has an excellentregulatory history with regular inspections by all appropriate regulatory bodies(FDA, MHRA) and the clients of Top API development GMP certified companies

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CMO Micronization

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By using microfluidization technology process, Skyepharma provides solution to increase bioavailabity of poorly soluble APIs. It is also an interesting technology for micro and nano emulsion manufacturing.

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The mission of PMC ISOCHEM's R&D consists of chemical, process & analytical R&D, up-scaling & production improvement. Thanks to a broad technology platform & lifecycle management experience, PMC ISOCHEM's R&D team takes your product to the next level.

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Minakem High Potent's R&D department main functions include synthetic research and process development; analytical research and development; continuous improvement.

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Biondustria L.I.M's R&D Laboratories are in charge of developing new synthetic methods.

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Development of Chemical Procedures

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Our priority lies in the development of chemical procedures which are subsequently used in the making of products sold not only on Czech markets, but more importantly abroad.

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Support All Your Hazard Evaluation Needs

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During early process development, AMRI’s experts conduct a safety evaluation to identify potential issues during scale-up. At that stage and based on our evaluation, we redesign the processes to address all potentially hazardous issues.

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Virtual Booth Specializes in development of innovative, efficient manufacturing processes & reliable production of peptide-based APIs

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Offers More Than 6500 Biologically Active Pep...

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Bachem is specialized in the development and the manufacturing of biologically active peptides and complex organic molecules as active pharmaceutical ingredients (APIs) and as innovative biochemicals for research purposes.

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Virtual Booth Your partner in APIs Manufacturing since 1951.

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API Development Process Optimization

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LEBSA offers an end-to-end partnership for custom API development, scale-up and manufacturing with a flexible multipurpose EU GMP Pilot Plant, from grams to tones, with a client centric approach.

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Microbial Fermentation (Yeast & Bacteria)

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SAIS is a microbial fermentation CDMO service provider. It produces small molecules via fermentation for pharma and food industry. SAIS is a microbial fermentation CDMO which offers contract API development services including yeast and bacterial fermentation CDMO capabilities.

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Process Optimization, Building Block & Generi...

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MINAKEM's highly trained and professional research team develops new synthetic routes and supplies lab samples of new compounds or generic API's according to scalable and safe process. It also optimizes and scales up synthetic processes through lab work and pilot production.

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Custom Synthesis of Pharmaceutical Impurities

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The "Building T," found on the Axyntis Group’s Calais location, is a three-level independent workshop. Gravity enables the completion of all operations there, from synthesis to packaging, in an environment fully compliant with GMP.

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Route & Methods Development

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Whether it’s lead generation or optimization, route and methods development, screening, or scale-up, Cayman’s experienced medicinal and organic chemists, structural biologists, and biochemists possess the competencies to augment your pre-clinical drug discovery and development needs.

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Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry. Biophore has emerged as a trusted partner in the generic industry across US, Europe and other regulated markets.

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Eurofins CDMO has a strong experience in impurity control strategy from IND through to commercial stages and have demonstrated track-record in the design and execution of fate and purge studies.

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Scale-Up For Commercial And Clinical Supply

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We use GMP facilities to manufacture batches of development products for clinical trials to support the validation of the product concept and for the later approval process. We are experienced with scale-up of complex dosage forms for full commercial scal

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Development of APIs

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Drug’On Pharma Switzerland was the last company to be set up in the Orofino Pharmaceuticals Group. The Group bought out the ex Knoll and Abbott manufacturing site in Liestal,Switzerland. The chemical manufacturing site produces active pharmaceuticals ingredients (API) and intermediates.

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Impurity Profile Characterisation

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Highly Potent API for Pre-Clinical Trials & C...

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CARBOGEN AMCIS provides services for the development and manufacture of highly potent APIs. Our facilities operate to current Good Manufacturing Practice (cGMP) and can produce material for preclinical testing, clinical trials and commercial use.

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Ultra & Nanofiltration

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Zach has over 30 years of experience in multi-step syntheses involving complex reactions.We have dedicated R&D and analytical development teams on each site, and state-of-the art analytical equipment.

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Virtual Booth Manufacturers of Life Science Intermediates, Excipients & APIs for Critical Pharmaceutical Applications.

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Custom Development & Optimization

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Biospectra provides custom API Development with various supports like Analytical support, Development Support and other supports through the life of your product.

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Development and optimization of synthetic pat...

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Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.

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Development of High-Value/Low-Volume Niche-Co...

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Sequent has invested in facilities with an objective of creating an integrated, flexible unit capable of manufacturing several niche & complex APIs. The manufacturing facalities are capable of meeting the growing demand of our key products in the USFDA and WHO regulated markets.

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Process Research, Development & Optimization

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Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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Offer End To End Partnership For Custom API D...

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With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.

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Our early investments in R&D enabled us to develop a basket of robust products for diverse markets across the world. Moreover, our laboratories are fully equipped with fume hoods and necessary analytical setup to take care of synthetic research from gram scale to kilogram scale.

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Extensive Experience in R&D of Iodine Derivat...

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Our portfolio includes 200+ Iodine Derivatives and 15+ APIs. We manufacture a range of Iodine derivatives on the commercial basis in India and supply around the globe.

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R&D & Manufacturing

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Kimia Biosciences' strength lies in focus on R & D where we propose to continuously invest and innovate to be in line with the global technological advancements and offer most cost effective processes to our pharmaceutical fraternity in our country as well as globally.

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Solid State Crystallography & Particle Size

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Crystec works with clients at each stage of the product development journey, from supporting initial compound selection decisions through to re-purposing of therapeutics to extend sales in the marketplace.

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Custom Synthesis for API Development

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Ipochem represents experience and proficiency in the chemical and pharmaceutical industry. Technologies and capabilities include the development and production of APIs as well as physical operations of milling and micronization.

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Contract Research

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Contract research for “Custom” process/ enzyme technology development.

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New Process Development & New Product Develop...

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Shanghai R&D center, namely Shanghai Parling PharmaTech Co.,Ltd, is responsible for new process development and new product development.

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Custom Synthesis of Pharmaceutical Impurities

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R&D center is located in High-tech park of Shanghai with area about 1,000 square meters. It is equipped with chemical synthesis room, formulation room and advanced instrument room. What’s more, there are 5 professionals focusing on new drug development.

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Cryogenic Micronization

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To prevent the degradation of highly sensitive products, to avoid polymorphic changes, to avoid an increase in amorphous particles, to allow the micronization of polymers.

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Micronization

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Our contract micronization services have been refined and improved based on actual in-depth experience gained from our daily processing operations. Our state-of-the art material handling service applies micronization technology based on this combination of improved equipment and practiced,

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Obtaining New Processes /Improving Existing ...

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Menadiona’s state of the art Research and Development Department with its skilled and experienced staff is constantly striving to obtain new synthetic processes as well as improving existing ones.

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Gram To Multi-Kilo Gram Scale Synthesis (Non-...

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Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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Phosgene Reactions & Phosgene Derivatives

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PMC ISOCHEM offers both custom manufacturing in phosgenation and downstreaming chemistry and a catalogue of phosgene derivatives.

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Virtual Booth CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Route Scouting

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Minakem High Potent's dedicated R&D team helps chemical developments, route scouting process optimizations, industrialization.

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Virtual Booth Production of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.

Pilot Synthesis

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Biondustria L.I.M's R&D Laboratories are in charge of pilot synthesis up to 30 litres.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Virtual Booth 100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Pharma ChemOutsourcing

Custom Synthesis & Development

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State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Separations Sciences

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AMRI's expert scientists routinely isolate materials of interest, including controlled substances and potent compounds, through classic and chromatographic techniques.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Separation & Purification

Virtual Booth Your partner in APIs Manufacturing since 1951.

CPhI Worldwide

Stand No. 42H02

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Complete Development of API

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LEBSA offers an end-to-end partnership for custom API development, scale-up and manufacturing with a flexible multipurpose EU GMP Pilot Plant, from grams to tones, with a client centric approach.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Overview

Virtual Booth Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.

Therapeutic Protein Extraction & Purification

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SAIS is a therapeutic protein extraction and purification CDMO service provider with expertise in extracting, purifying and analysing sophisticated proteins from natural origin raw materials. SAIS has API protein purification CDMO capabilities and protein extraction CDMO capabilities.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Separation & Purification

Virtual Booth CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

New Synthetic Routes Development

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MINAKEM's professional research team develops new synthetic routes and supplies lab samples of new compounds or generic API's according to scalable and no-hazardous processes.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Evaluation & Development

Virtual Booth Expertise in Dyes & Fine Chemicals// Project Support from Gram to Ton// USFDA & ANSM Inspected

CPhI Worldwide

Booth No. 101C70

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CDMO Capabilities for APIs

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An offer complying with Good Manufacturing Practices (GMP), closely monitored by the Quality Insurance and Regulatory Affairs services: Laboratory, Kilolab, Pilot, industrial production and preparatory chromatography services.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Overview

Virtual Booth Research-driven Global Pharmaceutical Company, focused on niche API for the Generic Industry.

CPhI Middle East & Africa

API Development

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Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry. Biophore has emerged as a trusted partner in the generic industry across US, Europe and other regulated markets.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Overview

Virtual Booth Streamline Drug Development - bring your Drug to Clinic Faster.

Nordic Life Science Days

Impurity Synthesis

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Eurofins CDMO offers services during the whole development process and manage impurities synthesis and control.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Development of Fine Chemicals & Intermediates

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Drug’On Pharma Switzerland was the last company to be set up in the Orofino Pharmaceuticals Group. The Group bought out the ex Knoll and Abbott manufacturing site in Liestal,Switzerland. The chemical manufacturing site produces active pharmaceuticals ingredients (API) and intermediates.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Fine Chemical / Intermediate

Process Development & cGMP Manufacture

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Carbogen Amcis SAS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Virtual Booth Committed to providing Highly Customized Solutions for all your Development Programs.

Ozonolysis

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Zach has over 30 years of experience in multi-step syntheses involving complex reactions.We have dedicated R&D and analytical development teams on each site, and state-of-the art analytical equipment.

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Pharma Service: API & Drug Product Development

Category: API Development >> Ozonolysis, Ozonolysis

Co-Micronization

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Jetpharma is your trusted partner for Contract Micronization Services. Jetpharma offers you the highest level of Contract Micronization Services utilizingnits own technology.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Micronization

Custom Development & Optimization

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Alven's R&D team focuses on the process development and specializes in the transfer of technology from the laboratory scale to the pilot plant scale. This knowledge is used for the development of branded and generic API?s as well.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Synthesis/Isolation of Impurities, Metabolite...

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Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Impurity Identification

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Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques for impurity identification.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Development of Customized APIs

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Siegfried’s chemical expertise centers on the development and production of active pharmaceutical ingredients and intermediates, thus making Siegfried the ideal partner for both cGMP and non-cGMP active pharmaceutical ingredients and intermediates.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

Process Modelling

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Utilising kinetic (e.g. DynoChem, Matlab), statistical (e.g. Umetrics) and process (e.g. CFD, Aspen) modelling platforms to build process understanding leading into scale-up strategies.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

New Drug Process & Analytical R&D

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KriSan Biotech offers world class services of new drug process and analytical R&D for small molecules and peptides from Pre-clinical (IND) to Phase II.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

BioReliance® End-to-End Solutions

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BioReliance® End-to-End Solutions encompass the support and expertise you need to accelerate clinical drug development, scale your process and implement local production facilities, globally.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Process Safety / Hazard Assessment

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Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Safety Assessment

Route selection

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Our custom small molecule API development capabilities include Route selection.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Evaluation & Development

Metabolite And Impurity Synthesis

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Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

ISO Certified Facility for R & D of Active In...

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The Pharma & Chemical division is dedicated to research, development and production of active ingredients and synthetic intermediates – used for manufacturing active ingredients – on behalf of various industries and in compliance with good manufacturing practices (GMP).

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

Control of Impurities

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Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual Booth Your partner for smart CDMO of intermediates and APIs, catalogue of intermediates & generic APIs, drug delivery solution

American DDF Summit

Hydrogenation Process & Technology

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PMC ISOCHEM offers an expertise of more than 30 years in hydrogenation technology. It runs a vast range of stainless steel and glass-lined 2.8 bar pressure reactors from 4000L to 8000L and stainless steel 2000L, 40 bar hollow-shaft gassing technology.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Hydrogenation

Virtual Booth CDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Development of Highly Active Pharmaceutical I...

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Minakem High Potent has pioneered from the late 90’s the utilization of containment technology (closed systems) for the production of HAPIs.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: High Potency APIs (HPAPIs)

Virtual Booth Production of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.

Degradation Impurities

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Biondustria L.I.M's R&D Laboratories are in charge of synthesizing process and degradation impurities for analytical department and to support customers in developing their generics.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Chemical Purification

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AMRI’s inventory of chromatography media for preparative applications (chiral and achiral) provides extensive screening options as well as quicker turnaround on the processes.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Separation & Purification

Virtual Booth Your partner in APIs Manufacturing since 1951.

CPhI Worldwide

Stand No. 42H02

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Complete Development of Building Blocks

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LEBSA offers an end-to-end partnership for custom API development, scale-up and manufacturing with a flexible multipurpose EU GMP Pilot Plant, from grams to tones, with a client centric approach.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Fine Chemical / Intermediate

Virtual Booth Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.

Organometallic Compounds Synthesis

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SAIS is a organometallic chemistry CDMO service provider, providing organometallic API CDMO services, complex and long synthesis of organometallic compounds, custom organic synthesis & manufacturing of organometallic compounds by organometallic multistep organic synthesis for API development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Organometallic Chemistry

Virtual Booth Expertise in Dyes & Fine Chemicals// Project Support from Gram to Ton// USFDA & ANSM Inspected

CPhI Worldwide

Booth No. 101C70

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Scale-Up Capabilities

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The Axyntis Group offers a wealth of services at the Kilolab level: production of clinical bundles, manipulation of highly active compounds, etc. Kilolab houses biotechnology companies and accelerates their bioproduction development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Virtual Booth Streamline Drug Development - bring your Drug to Clinic Faster.

Nordic Life Science Days

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Eurofins CDMO's development team operates well-equipped laboratories to handle the most complex API development challenges.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Overview

Route Finding through to cGMP Production

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Carbogen Amcis SAS delivers leading process research services that support the drug development process. Early Active Pharmaceutical Ingredient (API) manufacture centers on the rapid synthesis of supplies necessary to perform both toxicology and early-phase clinical trials.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Evaluation & Development

Virtual Booth Committed to providing Highly Customized Solutions for all your Development Programs.

Spray Drying

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Zach has over 30 years of experience in multi-step syntheses involving complex reactions.We have dedicated R&D and analytical development teams on each site, and state-of-the art analytical equipment.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Spray Drying

Pilot & Commercial Quantities of APIs

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Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Process Development

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Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Lab POC Feasibility

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Industrial benchmark driven POC (e.g. cost, yield etc.)

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

ISO Certified Facility for R&D of Synthetic I...

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The Pharma & Chemical division is dedicated to research, development and production of active ingredients and synthetic intermediates – used for manufacturing active ingredients – on behalf of various industries and in compliance with good manufacturing practices (GMP).

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Fine Chemical / Intermediate

Reference Standard Characterization

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Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques for reference standard characterization.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Contract Micronization Services

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Jetpharma is your trusted partner for Contract Micronization Services. Jetpharma offers you the highest level of Contract Micronization Services utilizingnits own technology.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Micronization

Development of Customized Intermediates

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Siegfried offers experience and proficiency in the chemical and pharmaceutical industry. Siegfried is the ideal partner for both cGMP and non-cGMP intermediates.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Fine Chemical / Intermediate

Laboratory & Pilot Process Scale-Up

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Process development and route optimization are core competencies at Ash Stevens. Our company has a dedicated staff of professional process chemists and engineers with substantial experience and expertise in the development of robust cGMP chemical processes.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Small And Large Scale Process Development & O...

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Our experienced team are here to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Stable Label Compounds (Deuterium Labelled)

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Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Radiolabelled Compound

Optimization & Fast Industrialization of Proc...

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Procos S.p.A. is specialized in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and Generic API manufacturing.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

Virtual Booth Your partner for smart CDMO of intermediates and APIs, catalogue of intermediates & generic APIs, drug delivery solution

American DDF Summit

Halogenation Process & Technology

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PMC Isochem offers halogenation technology for custom manufacturing and catalog products. Iodination, bromination and chorination are routinely run at large scale using various techniques and reagent.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Halogenation

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Impurity Isolation and Identification

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AMRI's scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

Virtual Booth Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.

Route Scouting

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SAIS is a route scouting CDMO service provider. Their API route scouting CDMO capabilities includes API development route scouting for custom synthesis & manufacturing process, route scouting for cost effective scale up with cost evaluation, feasibility evaluation.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Route Evaluation & Development

Virtual Booth Expertise in Dyes & Fine Chemicals// Project Support from Gram to Ton// USFDA & ANSM Inspected

CPhI Worldwide

Booth No. 101C70

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CDMO Capabilities for Fine Chemicals

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Axyntis Group has expanded its offerings in fine chemicals and is able to handle projects from the gram to the ton, while complying with Good Manufacturing Practices (GMP) and maintaining high hygiene, security and quality standards.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Fine Chemical / Intermediate

Virtual Booth Streamline Drug Development - bring your Drug to Clinic Faster.

Nordic Life Science Days

API Development Process Optimization

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Eurofins CDMO team has considerable experience with process development, successfully introducing hundreds of chemical steps to cGMP scale up and advancing several API’s to commercialization.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Process Development & Optimization

From Development Scale to Commercial Manufact...

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- Service Details

Carbogen Amcis SAS delivers leading process research services that support the drug development process. Early Active Pharmaceutical Ingredient (API) manufacture centers on the rapid synthesis of supplies necessary to perform both toxicology and early-phase clinical trials.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

Virtual Booth Committed to providing Highly Customized Solutions for all your Development Programs.

Hydrogenation

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Zach has over 30 years of experience in multi-step syntheses involving complex reactions.We have dedicated R&D and analytical development teams on each site, and state-of-the art analytical equipment.

- Directory Listing

Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Hydrogenation

Micronization of APIs for Development

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Jetpharma is your trusted partner for Contract Micronization Services. Jetpharma offers you the highest level of Contract Micronization Services utilizingnits own technology.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Micronization

Transfer from laboratory scale to Kilolab.- a...

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Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities