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What is API Custom Synthesis and Manufacturing? API custom synthesis CMOs offer development and/or manufacturing of early or advanced intermediates and active pharmaceutical ingredients. API CMOs can deliver one or all building blocks along your synthetic pathway including biocatalytic steps up to the final API. All compounds can be tailored to meet your particular requirements of API Custom synthesis, with target compound synthesis & API organic synthesis requirements based on a predefined process or ‘from scratch’. Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, i.e., you can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods required. Find API custom synthesis & manufacturing service providers (CMO / CMOs) for API route scouting services, API custom manufacturing & custom synthesis services. Find custom API CMOs, custom API service providers, custom API manufacturers CMOs, custom API synthesis CMOs for contract API manufacturing. Custom APIs CMOs provide services for: APIs High-potency APIs (HAPIs) Early and late stage/advanced intermediates (IMs). The Custom APIs CMO is able to provide a complete solution during the entire molecule lifecycle — from the preclinical stage up to the market (non-GMP and GMP). The Custom Drug Manufacturing services are offered as a complete package or on a modular basis. The top API manufacturers CMOs with GMP certified custom manufacturing services include: Process development and optimization for APIs and IMs Up-scaling Process validation Development and validation of analytical methods Synthesis of impurities, reference standards, etc. Salt screening, co-crystal screening, polymorphism studies Stability studies according to ICH guidelines Sourcing of raw materials or IMs Production and supply of APIs and IMs Technical transfer to another manufacturer/manufacturing site All top API manufacturers CMOs offer Multistep API Synthesis services on an exclusive basis and all information is treated strictly confidential. In working with Custom manufacturing services customers and Custom API services providers partners, the best custom manufacturing service providers believe in full transparency and open communication. Custom manufacturing services are directly involved in discussions with Custom manufacturing service providers partners and are always fully aware of the activities and progress. The custom synthetic APIs have to gain access to Custom API CMOs in an integrated, global network of Custom API CMO partners and pool of Custom CMOs, as well as the knowledge gained from our years of experience and that of our industry-leading partners. Phosgenation services for Small molecule APIs & Pharma chemicals The specialist teams of Phosgenation services cover all stages of the pharmaceutical value chain and are able to provide complete solutions to meet the specific needs of each customer. As well as custom synthesis and API manufacturing, API manufacturers CMOs offer a range of complementary services. With Custom API synthesis, 4 cGMP plants regularly inspected by the FDA for commercial production supported by three ISO 9001 sites in France and North America, CMO services customers have access to a powerful industrial network of facilities with a high level of Quality, cGMP Custom API Manufacturing Safety and Environmental compliance. Top API manufacturers CMOs like PCAS invests on an ongoing basis in its production sites with API route scouting services in order to provide pharmaceutical laboratories with state of the art equipment combined with cutting-edge technology in organic chemistry associated with proprietary Custom API manufacturing technology for unique biocatalytic routes. API custom synthesis services companies and Route scouting CMOs conduct GMP manufacturing of APIs or Intermediates from kilos to multi-tons quantities . The range of scale and seamless collaboration within our manufacturing sites allow PCAS to accommodate most of the projects regardless size and complexity. Where to Find the Best custom API manufacturing services Top Custom API CMOs are the requirement for GMP “One-Stop-Shop”, custom API services are needed for a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry. Top Organic Synthesis CMOs and custom API service providers 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 tonnes, with a client centric approach. Custom GMP manufacturing services range from developing new synthesis routes to optimising and validating industrial manufacturing processes// development of analytical methods to validation// preparation of documentation required for clinical trials. Best GMP certified custom manufacturing service providers are a specialized Pharma company focusing on the niche therapeutic areas of CNS, ARVs and Controlled substances having tremendous future growth potential from Custom synthesis CMOs. By virtue of this niche focus Organic Synthesis CMOs have registered an impressive growth over the years. The pharmaceutical contract manufacturing industry will continue to achieve consolidation via mergers and acquisitions (M&A). Consolidation of API custom synthesis CMOs is expected to peak in the next five years, cGMP custom API CMOs, as more CMOs strive to provide a one-stop-shop, Custom synthesis of API & intermediates offering services from APIs to finished doses. Excess capacity is also the driver of the recent M&A activities. Top API custom synthesis CMOs offer Affordability is no longer the main parameter in selecting CMOs for partnership, as sponsor companies will increasingly emphasize quality, compliance with regulatory demands and service requirements. Technological advances will also stimulate that market from 2015 to 2025. Also custom API synthesis CMOs invest in custom API CMOs for single-use technologies for biopharmaceutical manufacturing and continuous manufacturing processes. CMOs will also invest heavily to expand their capacities in HPAPIs.” Along with prediction of the overall world market for outsourced drug production, the new report gives revenue forecasting of 11 world-level submarkets to 2025: Active pharmaceutical ingredients (APIs), with sub forecasts for custom synthetic APIs for generic APIs, high potency active pharma ingredients (HPAPIs) and other products Finished dosage formulations (FDFs), with sub forecasts for solid dose forms, injectable dosages, and other agents GMP certified custom manufacturing Other applications of outsourced Custom CMOs production Clinical manufacturing Custom synthesis APIs Commercial manufacturing & Custom API manufacturing requirements In 2015 Custom API services providers had projects account for most CMO revenue. However, improved funding for early-stage projects in the US and EU will drive demand for clinical trial material manufacturing towards the middle of the forecast period. The growing R&D pipeline of novel antibody-drug conjugates (ADCs) will also create more opportunities for CMOs offering specialised manufacturing technologies, further stimulating the market. Global top Custom APIs CMOs reports new study also discusses regulatory developments and demand for pharma contract manufacturing services in leading and emerging national markets along with custom API synthesis services. Custom Drug Manufacturing Custom CMOs work analyses the US, Japan, Germany, France, Italy, Spain, the UK, China, India, Brazil, Russia and South Korea, with revenue forecasting to 2025. Developed markets account for the greatest demand for outsourced drug manufacturing. The US and EU accounted for 63.9% of CMO revenues in 2013. And concerns with regulatory compliance led some Western companies to seek outsourcing partners closer to home custom API manufacturing. Custom Synthesis and Contract Manufacturing Custom GMP synthesis offers Emerging national markets, however, will still generate much business from pharma companies wanting custom medicine production. That Custom APIs investigation provides quantitative and qualitative analyses of Custom synthesis APIs the pharma contract manufacturing market for the period 2015 to 2025. Best custom manufacturing service providers also shows interviews with companies. Pharmaceutical Contract Manufacturing offers Custom GMP manufacturing: World top route scouting service providers add to the reports portfolio of market analysis on pharmaceutical outsourcing and other Small Molecule Synthesis healthcare industries. Search for contract manufacturing organizations (CMOs) for custom API synthesis & manufacturing services from Custom API services providers. Search for cGMP custom API CMOs, custom API synthesis services and custom API manufacturing service providers CMOs. Find capabilities like multistep API organic synthesis. Contract API Manufacturing // API Custom Synthesis & Manufacturing Services|CMOs With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. To some extent, the challenges of commercial API manufacturing vary, based on scale. A large-scale CMO might not necessarily be suited to working in an early stage of development. Applying later-stage standards early on, for example, could waste time and money custom API synthesis– ultimately derailing the project timeline and budget. At the same time, consideration must always be given to later-stage manufacturing processes & requirements during earlier phases of the project to maximize efficiency and minimize cost & time-to-market, Contract Chemistry. It requires striking a balance – maximizing early-stage success while minimizing challenges in the future. Scale-Up Gradually to Identify & Solve New Challenges at Each Stage Many aspects of early-stage production, such as handling and storing raw materials, only become challenging when production is scaled up. Issues with heat generation and dissipation also tend to come to the forefront when production is dramatically increased custom API manufacturing service providers. In addition, larger volumes of custom API manufacturers often mean longer reaction times. API custom manufacturers can be problematic for certain processes. To detect and resolve these potential issues, production is scaled gradually at the Custom manufacturing services facility, going from micro or milligram scale to gram scale, then pilot scale to full production. Lifecycle Management Key to Successful Process Scale-Up When preparing to scale up drug production, it’s important to partner with a CMO well-versed in lifecycle management. A contract firm that has the extensive expertise needed to work comfortably at all scales can improve many aspects of the scale-up process in custom API manufacturing services measurable ways, making it smoother, faster, and easier overall. The API custom manufacturing issues that arise when shifting from one scale to another can be unpredictable, and because of this,planning and forecasting should be done as early in the R&D process as possible. The more experienced the transfer team, the more streamlined and simplified the technology transfer can be. Several techniques are currently used to make production more efficient. Scouting alternate synthetic routes to a molecule has become standard, and helps control costs by accelerating production. This can also reduce time spent on regulatory compliance, as there are less steps to document, and less analysis to be made throughout the process. How to find the right supplier for Custom Synthesis? What are Custom API CMOs? What is a Custom API CMO and how can I find the best solution provider for my project? API custom manufacturing and Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, i.e., you can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods required and that makes it difficult for API custom manufacturers CMOs to find new solutions to problems faced with hazardous chemicals. There is a big difference between the API custom manufacturing services conditions used for small-scale custom synthesis of entirely new molecules and those used for standard multi ton per annum manufacturing multistep API organic synthesis, just as strictly regulated cGMP syntheses are different from those performed for R&D purposes. Active pharmaceutical ingredients custom synthesis Learn more about the market of custom synthesis services, the different kinds Active ingredients custom synthesis of service providers (e.g., CROS and CMOs) and how you can find the best provider for your projects. A Contract Research Organization (CRO) for Custom APIs CMO enables the outsourcing of a broad variety of research activities from custom synthesis of small molecules to clinical trials of a new drug, which helps to enliven the commercial research culture toward an international, innovation-based (drug) industry [1]. CROs, with their new epistemic skills and capacities, are both manifestations of the changes in commercial research cultures as well as the vehicles to achieve them. In contrast to Contract Manufacturing Organizations (CMOs), which produce ten to thousands of tons of fine chemicals on multi-purpose plants, CROs have a lab bench or patient population as their working base. However there is an custom API synthesis & manufacturing services API custom synthesis services, interface when it comes to the pilot plant, which is needed at a certain stage in both industries. API custom synthesis oriented pharmaceutical CROs are active in the clinical part of drug development, operating in the sphere of Top custom API service providers, and patients, but also dealing with medical devices, diagnostics, and drug administration. Conversely, Top custom API service providers mainly focus on only two aspects of the Top custom API services value chain, namely the small-scale preparation of active ingredients of new drugs and the design and basic development of the manufacturing process. As a result, Top custom API manufacturers attract more attention, and the Top custom API manufacturers consider the outsourcing of API development to predominantly include Top Custom API services tasks with lead identification, compound screening, lead optimization, or clinical trials. Therefore, choosing the Best custom API service providers for contract businesses offering custom synthesis and research services is rather small compared to that of Custom manufacturing services CROs.

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AMRI

AXYNTIS Group

Anacipher

Angelini Pharmaceuticals ACRAF

Arevipharma GmbH

Avra Laboratories Pvt. Ltd.

Bachem AG

CTX LIFESCIENCES PRIVATE LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Cayman Chemical Company Inc.

ChemCon GmbH

ChemGenix Laboratories Pvt Ltd

Chemtos

DOTTIKON EXCLUSIVE SYNTHESIS AG

Dalton Pharma Services

Diverchim S.A.

Farmak A.S

Fermion Oy

Huvepharma Italia S.r.l

Infinium Pharmachem Pvt. Ltd.

Inke S.A.

Ipochem Ltd

KriSan Biotech

LEBSA

Legacy Pharmaceuticals Switzerland

M2I Life sciences

Maithili Life Sciences Private Limited

Menadiona, S.L.

Merck Millipore

Minakem High Potent

Neuland Laboratories Inc

Olon Spa

PCI Synthesis

PMC Isochem

PROCOS S.p.A.

Pfanstiehl, Inc

Phyton Biotech LLC

Polfa Tarchomin S.A

Priyans Drugs

Robinson Brothers Ltd

SANOFI Active Ingredient Solutions

ScinoPharm Taiwan, Ltd.

Servier CDMO

Shanghai Chemspec Corporation

Siegfried AG

Stason Pharmaceuticals, Inc.

Supriya Lifescience Limited

TOPCHEM PHARMACEUTICALS

ZACH SYSTEM SPA

ZCL CHEMICALS LTD

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

American DDF Summit

American DDF Summit

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PMC ISOCHEM offers cGMP and non cGMP industrial exclusive custom synthesis and provides tailor made services from development to production, including route selection, process and analytical development as well as process optimization.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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

BioTaiwan

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Minakem is a recognized world leader custom manufacturer for development and commercialization of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 6, OEL < 0.1 g / m3 / shift. (APIs).

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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Development, production, marketing of APIs, Intermediates & specialities// FDA inspected.

CPhI Worldwide

CPhI Worldwide

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Our analytical centre provides these methods & equipment: Analytical methods and equipment are validated; LCMS, GCMS, HPLC, TLC; UV/VIS and IR spectrometry; Capillary electrophoresis; Thermal analysis – DSC, Calorimetry; NMR (400 MHz) + xRAY; PSD analysis

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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

Route Scouting

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CPhI Worldwide

CPhI Worldwide

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

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

CPhI Worldwide

CPhI Worldwide

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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World’s Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

CPhI Worldwide

CPhI Worldwide

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Phyton Biotech is the World's Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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

CPhI Worldwide

CPhI Worldwide

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If you need products that are not offered from stock, Bachem's custom synthesis team is happy to support you in bringing your project from research scale to bulk cGMP APIs utilizing effective technology transfer between Bachem locations worldwide.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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Your partner in APIs Manufacturing since 1951.

CPhI Worldwide

CPhI Worldwide

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

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Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.

Route Scouting

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CPhI Worldwide

CPhI Worldwide

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SAIS is a route scouting service provider with expert API route scouting CMO capabilities. Their offerings include API manufacturing route scouting for custom synthesis & manufacturing process, route scouting for cost effective scale up and cost & feasibility evaluation.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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

CPhI Worldwide

CPhI Worldwide

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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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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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Our team of chemists brings unmatched experience to solving difficult synthetic routes and performing complex, multi-step syntheses. We specialize in the production of eicosanoids (e.g., prostaglandins and leukotrienes), fatty acids, cannabinoids, and complex heterocycles.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

CPhI Worldwide

CPhI Worldwide

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Supply of gram quantities for use as building blocks, drug screening, purity standards, etc. ScinoPharm can supply CGMP materials beginning at the IND stage and continuing through clinical needs as well as launch and post-launch supply requirements.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Neuraxpharm's APIs manufacturing plant

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Inke has been developing, patenting and implementing its own synthetic routes and polymorphs for the manufacture of active pharmaceutical ingredients since 1980.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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

Pharma ChemOutsourcing

Pharma ChemOutsourcing

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At Zach System, controlled by holding Zambon Company SpA, we specialize in providing Active Pharmaceutical Ingredients (API), quality intermediates and custom synthesis services that match your schedules and budget targets.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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DOTTIKON EXCLUSIVE SYNTHESIS AG provides chemical custom manufacturing services to scale up from grams to multi-tons, including routefinding, process design, process development, small-scale and pilot production, manufacturing, qualification and validatio

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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OVERCOME YOUR LACK OF CAPACITY AND TIME WITH CUSTOM MANUFACTURING

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Long-established contract manufacturing services. Comprehensive customer support, from early clinical stage up to the commercial supply. Tailor-made offerings to meet customer-specific needs.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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

American DDF Summit

American DDF Summit

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PMC ISOCHEM has developed over 40 years a first class technology platform offering to our customers a competitive development and manufacturing cGMP service with a strong position in hazardous chemistry.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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

CPhI Worldwide

CPhI Worldwide

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.

CPhI Worldwide

CPhI Worldwide

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SAIS is a cGMP compliant custom API manufacturing CMO service provider. They offer custom API synthesis services, custom API manufacturing services, multistep API organic synthesis and other API manufacturing complex long organic synthesis services.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

CPhI Worldwide

CPhI Worldwide

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ScinoPharm possesses a full range of chemistry capabilities and has extensive experience in synthesizing complex molecules. Depending on individual requirements, we develop new synthetic routes, or scale up and optimize processes based on the customer’s technology.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

Neuraxpharm's APIs manufacturing plant

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High?added value active substances with complex synthesis processes, mainly for use in respiratory and CNS therapies

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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

Pharma ChemOutsourcing

Pharma ChemOutsourcing

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At Zach System, controlled by holding Zambon Company SpA, we specialize in providing Active Pharmaceutical Ingredients (API), quality intermediates and custom synthesis services that match your schedules and budget targets.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Topchem Pharmaceuticals has an extensive and proven track record in designing new syntheses, combining high creativity with a sound commercial focus, and developing these processes up to full scale tonnage pharmaceutical production.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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CTX Life Sciences focusses to develop and manufacture active pharmaceutical ingredients (APIs) and intermediates for global supply, complying with quality and regulatory requirements of our customers

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Our capabilities include: Process Research – Custom synthesis and synthetic route evaluation from g – kg for API’s or intermediates.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Your GMP “One-Stop-Shop”, Angelini Fine Chemicals is a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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

Pharma ChemOutsourcing

Pharma ChemOutsourcing

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Zach System's core chemistries and technologies include asymmetric synthesis.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Avra’s primary focus is to provide synthetic chemistry services that include route identification and optimization to enable preparation of compounds on a multi-gram to multi-ton scale.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Supriya Lifescience's contract manufacturing capabilities will encompass the capability to handle complex chemical reactions.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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We offer Bulk Actives, Intermediates and services for Custom Synthesis providing an integrated solution for the diverse requirements of generic and innovator companies in Iodine Chemistry.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

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Fermion R&D has over 40 years API development experience. Tacit knowledge is combined into an efficient, standardized development scheme saving time and costs.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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M2I Pharma & Chemical division has two activities: Sale of pharmaceutical APIs and synthetic intermediates, Sale of Research & Development as well as Production services to third parties (custom synthesis business or CRMO, Contract Research & Manufacturing Organisation).

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Here at Robinson Brothers, we can further rapidly scale processes and products as necessary from laboratory grams to kilograms in our Kilo-Laboratory and/or Pilot Plant facilities and thence in an Operations Plant to manufacture multi-tonne quantities.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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From route scouting to full process development, DIVERCHIM provides to its customers a robust, reproductible and cost-effective manufacturing process.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Avra’s primary focus is to provide synthetic chemistry services that include route identification and optimization to enable preparation of compounds on a multi-gram to multi-ton scale.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Menadiona has more than 30 years of experience offering contract manufacturing and custom synthesis services, having a long track record of successful projects in the development and production of fine chemicals, advanced intermediates and active pharmaceutical ingredients.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Our Custom Manufacturing Solutions (CMS) division has proven expertise in manufacturing at varied scales, a deep understanding of complex chemistry and manufacturing facilities compliant with the guidelines of the leading regulatory authorities

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Chemspec conducts research studies for pharmaceutical chemicals, including custom synthesis and process development of pharmaceutical intermediates and APIs and also research studies for liquid crystal.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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With our wide range of functional products, we support you, whether for ethical products, OTC products or line extensions, in finding the optimal formulation. Thanks to our global presence, we'll help you to ensure smooth upscaling to production.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

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PCI has an experienced, highly skilled team of process chemists and chemical engineers who are able to practice a wide range of reaction technologies at different scales.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Uetikon is a full service provider supporting your entire development process from first small amounts to the commercial production quantities.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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 Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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DOTTIKON EXCLUSIVE SYNTHESIS AG has nine cGMP multipurpose and specialized multi-ton production plants including hazardous reactions, high-pressure (50 bar), low-temperature ( 100°C), and continuous processing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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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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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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We specialize in small-scale synthesis of: APIs, Metabolites, Impurities, Analogues, Intermediates

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Benefit from Legacy Pharmaceutical's GMP standards and expertise in the development and management of production processes and production environments in the production of pharmaceuticals and active ingredients.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Our talented and innovative development chemists are well experienced either in the development of entirely new synthetic routes or adapting and optimizing an existing process (from Siegfried or our customers).

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Exclusive custom manufacturing of generic and innovative APIs, as well as of other specialty chemicals.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

API Synthesis

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Our active pharmaceutical ingredient (API)-related portfolio includes folates and custom synthesis, as well as our EMPROVE® api product family. Furthermore we offer activated PEGs that are used for drug conjugation.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Synthetic Labs are supported by expert team of scientist in handling mg to Kg scale Reactions, adequate Utility Services, hygienic Environment, cryogenic & High pressure Reaction Facilities and separate Laboratories for CRAMS and Generic Research.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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ChemGenix offers full range of custom designed manufacturing services to their customers.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Olon S.p.A, has always been at the flank of the largest Multinationals of the pharmaceutical industry producing for them very advanced intermediates as well as APIs principles on an exclusive basis. About 40% of Olon’ sales turnover comes from API contract manufacturing activities.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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With over 50 years experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

API Synthesis

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Offers API synthesis that includes custom manufacturing of organic molecules from milligram to kg quantities. Also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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ChemGenix offers full range of custom designed manufacturing services to their customers.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

- Service Details

ChemGenix offers full range of custom designed manufacturing services to their customers.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

Route Scouting

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ChemCon takes on projects anywhere between developing a synthetic route from scratch to adapting your technical package for immediate process validation and manufacturing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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ChemGenix offers full range of custom designed manufacturing services to their customers.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

- Service Details

ChemGenix offers full range of custom designed manufacturing services to their customers.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Huvepharma® Italia is a recognized as a reliable supplier of development and manufacturing services of APIs & advanced intermediates for leaders in the international market.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Olon's R&D expertise extends over a wide range of areas. It includes: development of synthetic route of new chemical entities; production of GMP material for clinical supply; process improvement activities.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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The following operations can be performed on installations: synthesis at -10 ÷ 1100C, crystallization at: -10 ÷ 800C, vacuum and pressure filtration, vacuum distillation, vacuum drying at temperature up to 800C, grinding, micronisation and ultrafiltration.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

What is API Custom Synthesis and Manufacturing? API custom synthesis CMOs offer development and/or manufacturing of early or advanced intermediates and active pharmaceutical ingredients. API CMOs can deliver one or all building blocks along your synthetic pathway including biocatalytic steps up to the final API. All compounds can be tailored to meet your particular requirements of API Custom synthesis, with target compound synthesis & API organic synthesis requirements based on a predefined process or ‘from scratch’. Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, i.e., you can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods required. Find API custom synthesis & manufacturing service providers (CMO / CMOs) for API route scouting services, API custom manufacturing & custom synthesis services. Find custom API CMOs, custom API service providers, custom API manufacturers CMOs, custom API synthesis CMOs for contract API manufacturing. Custom APIs CMOs provide services for: APIs High-potency APIs (HAPIs) Early and late stage/advanced intermediates (IMs). The Custom APIs CMO is able to provide a complete solution during the entire molecule lifecycle — from the preclinical stage up to the market (non-GMP and GMP). The Custom Drug Manufacturing services are offered as a complete package or on a modular basis. The top API manufacturers CMOs with GMP certified custom manufacturing services include: Process development and optimization for APIs and IMs Up-scaling Process validation Development and validation of analytical methods Synthesis of impurities, reference standards, etc. Salt screening, co-crystal screening, polymorphism studies Stability studies according to ICH guidelines Sourcing of raw materials or IMs Production and supply of APIs and IMs Technical transfer to another manufacturer/manufacturing site All top API manufacturers CMOs offer Multistep API Synthesis services on an exclusive basis and all information is treated strictly confidential. In working with Custom manufacturing services customers and Custom API services providers partners, the best custom manufacturing service providers believe in full transparency and open communication. Custom manufacturing services are directly involved in discussions with Custom manufacturing service providers partners and are always fully aware of the activities and progress. The custom synthetic APIs have to gain access to Custom API CMOs in an integrated, global network of Custom API CMO partners and pool of Custom CMOs, as well as the knowledge gained from our years of experience and that of our industry-leading partners. Phosgenation services for Small molecule APIs & Pharma chemicals The specialist teams of Phosgenation services cover all stages of the pharmaceutical value chain and are able to provide complete solutions to meet the specific needs of each customer. As well as custom synthesis and API manufacturing, API manufacturers CMOs offer a range of complementary services. With Custom API synthesis, 4 cGMP plants regularly inspected by the FDA for commercial production supported by three ISO 9001 sites in France and North America, CMO services customers have access to a powerful industrial network of facilities with a high level of Quality, cGMP Custom API Manufacturing Safety and Environmental compliance. Top API manufacturers CMOs like PCAS invests on an ongoing basis in its production sites with API route scouting services in order to provide pharmaceutical laboratories with state of the art equipment combined with cutting-edge technology in organic chemistry associated with proprietary Custom API manufacturing technology for unique biocatalytic routes. API custom synthesis services companies and Route scouting CMOs conduct GMP manufacturing of APIs or Intermediates from kilos to multi-tons quantities . The range of scale and seamless collaboration within our manufacturing sites allow PCAS to accommodate most of the projects regardless size and complexity. Where to Find the Best custom API manufacturing services Top Custom API CMOs are the requirement for GMP “One-Stop-Shop”, custom API services are needed for a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry. Top Organic Synthesis CMOs and custom API service providers 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 tonnes, with a client centric approach. Custom GMP manufacturing services range from developing new synthesis routes to optimising and validating industrial manufacturing processes// development of analytical methods to validation// preparation of documentation required for clinical trials. Best GMP certified custom manufacturing service providers are a specialized Pharma company focusing on the niche therapeutic areas of CNS, ARVs and Controlled substances having tremendous future growth potential from Custom synthesis CMOs. By virtue of this niche focus Organic Synthesis CMOs have registered an impressive growth over the years. The pharmaceutical contract manufacturing industry will continue to achieve consolidation via mergers and acquisitions (M&A). Consolidation of API custom synthesis CMOs is expected to peak in the next five years, cGMP custom API CMOs, as more CMOs strive to provide a one-stop-shop, Custom synthesis of API & intermediates offering services from APIs to finished doses. Excess capacity is also the driver of the recent M&A activities. Top API custom synthesis CMOs offer Affordability is no longer the main parameter in selecting CMOs for partnership, as sponsor companies will increasingly emphasize quality, compliance with regulatory demands and service requirements. Technological advances will also stimulate that market from 2015 to 2025. Also custom API synthesis CMOs invest in custom API CMOs for single-use technologies for biopharmaceutical manufacturing and continuous manufacturing processes. CMOs will also invest heavily to expand their capacities in HPAPIs.” Along with prediction of the overall world market for outsourced drug production, the new report gives revenue forecasting of 11 world-level submarkets to 2025: Active pharmaceutical ingredients (APIs), with sub forecasts for custom synthetic APIs for generic APIs, high potency active pharma ingredients (HPAPIs) and other products Finished dosage formulations (FDFs), with sub forecasts for solid dose forms, injectable dosages, and other agents GMP certified custom manufacturing Other applications of outsourced Custom CMOs production Clinical manufacturing Custom synthesis APIs Commercial manufacturing & Custom API manufacturing requirements In 2015 Custom API services providers had projects account for most CMO revenue. However, improved funding for early-stage projects in the US and EU will drive demand for clinical trial material manufacturing towards the middle of the forecast period. The growing R&D pipeline of novel antibody-drug conjugates (ADCs) will also create more opportunities for CMOs offering specialised manufacturing technologies, further stimulating the market. Global top Custom APIs CMOs reports new study also discusses regulatory developments and demand for pharma contract manufacturing services in leading and emerging national markets along with custom API synthesis services. Custom Drug Manufacturing Custom CMOs work analyses the US, Japan, Germany, France, Italy, Spain, the UK, China, India, Brazil, Russia and South Korea, with revenue forecasting to 2025. Developed markets account for the greatest demand for outsourced drug manufacturing. The US and EU accounted for 63.9% of CMO revenues in 2013. And concerns with regulatory compliance led some Western companies to seek outsourcing partners closer to home custom API manufacturing. Custom Synthesis and Contract Manufacturing Custom GMP synthesis offers Emerging national markets, however, will still generate much business from pharma companies wanting custom medicine production. That Custom APIs investigation provides quantitative and qualitative analyses of Custom synthesis APIs the pharma contract manufacturing market for the period 2015 to 2025. Best custom manufacturing service providers also shows interviews with companies. Pharmaceutical Contract Manufacturing offers Custom GMP manufacturing: World top route scouting service providers add to the reports portfolio of market analysis on pharmaceutical outsourcing and other Small Molecule Synthesis healthcare industries. Search for contract manufacturing organizations (CMOs) for custom API synthesis & manufacturing services from Custom API services providers. Search for cGMP custom API CMOs, custom API synthesis services and custom API manufacturing service providers CMOs. Find capabilities like multistep API organic synthesis. Contract API Manufacturing // API Custom Synthesis & Manufacturing Services|CMOs With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. To some extent, the challenges of commercial API manufacturing vary, based on scale. A large-scale CMO might not necessarily be suited to working in an early stage of development. Applying later-stage standards early on, for example, could waste time and money custom API synthesis– ultimately derailing the project timeline and budget. At the same time, consideration must always be given to later-stage manufacturing processes & requirements during earlier phases of the project to maximize efficiency and minimize cost & time-to-market, Contract Chemistry. It requires striking a balance – maximizing early-stage success while minimizing challenges in the future. Scale-Up Gradually to Identify & Solve New Challenges at Each Stage Many aspects of early-stage production, such as handling and storing raw materials, only become challenging when production is scaled up. Issues with heat generation and dissipation also tend to come to the forefront when production is dramatically increased custom API manufacturing service providers. In addition, larger volumes of custom API manufacturers often mean longer reaction times. API custom manufacturers can be problematic for certain processes. To detect and resolve these potential issues, production is scaled gradually at the Custom manufacturing services facility, going from micro or milligram scale to gram scale, then pilot scale to full production. Lifecycle Management Key to Successful Process Scale-Up When preparing to scale up drug production, it’s important to partner with a CMO well-versed in lifecycle management. A contract firm that has the extensive expertise needed to work comfortably at all scales can improve many aspects of the scale-up process in custom API manufacturing services measurable ways, making it smoother, faster, and easier overall. The API custom manufacturing issues that arise when shifting from one scale to another can be unpredictable, and because of this,planning and forecasting should be done as early in the R&D process as possible. The more experienced the transfer team, the more streamlined and simplified the technology transfer can be. Several techniques are currently used to make production more efficient. Scouting alternate synthetic routes to a molecule has become standard, and helps control costs by accelerating production. This can also reduce time spent on regulatory compliance, as there are less steps to document, and less analysis to be made throughout the process. How to find the right supplier for Custom Synthesis? What are Custom API CMOs? What is a Custom API CMO and how can I find the best solution provider for my project? API custom manufacturing and Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, i.e., you can order a specific molecule that is only synthesized on your request on the scale, with the purity and with the specification or methods required and that makes it difficult for API custom manufacturers CMOs to find new solutions to problems faced with hazardous chemicals. There is a big difference between the API custom manufacturing services conditions used for small-scale custom synthesis of entirely new molecules and those used for standard multi ton per annum manufacturing multistep API organic synthesis, just as strictly regulated cGMP syntheses are different from those performed for R&D purposes. Active pharmaceutical ingredients custom synthesis Learn more about the market of custom synthesis services, the different kinds Active ingredients custom synthesis of service providers (e.g., CROS and CMOs) and how you can find the best provider for your projects. A Contract Research Organization (CRO) for Custom APIs CMO enables the outsourcing of a broad variety of research activities from custom synthesis of small molecules to clinical trials of a new drug, which helps to enliven the commercial research culture toward an international, innovation-based (drug) industry [1]. CROs, with their new epistemic skills and capacities, are both manifestations of the changes in commercial research cultures as well as the vehicles to achieve them. In contrast to Contract Manufacturing Organizations (CMOs), which produce ten to thousands of tons of fine chemicals on multi-purpose plants, CROs have a lab bench or patient population as their working base. However there is an custom API synthesis & manufacturing services API custom synthesis services, interface when it comes to the pilot plant, which is needed at a certain stage in both industries. API custom synthesis oriented pharmaceutical CROs are active in the clinical part of drug development, operating in the sphere of Top custom API service providers, and patients, but also dealing with medical devices, diagnostics, and drug administration. Conversely, Top custom API service providers mainly focus on only two aspects of the Top custom API services value chain, namely the small-scale preparation of active ingredients of new drugs and the design and basic development of the manufacturing process. As a result, Top custom API manufacturers attract more attention, and the Top custom API manufacturers consider the outsourcing of API development to predominantly include Top Custom API services tasks with lead identification, compound screening, lead optimization, or clinical trials. Therefore, choosing the Best custom API service providers for contract businesses offering custom synthesis and research services is rather small compared to that of Custom manufacturing services CROs.

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