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- CONTRACT MANUFACTURING
- CYTOTOXIC COMPOUND
- ANTIBIOTIC
- ANTIBODY DRUG CONJUGATE
- BIOLOGICS, BIOPROCESS & FERMENTATION
- CHIRAL SYNTHESIS
- CLINICAL SUPPLY
- CONTINUOUS FLOW PROCESS
- CONTROLLED SUBSTANCE
- CUSTOM SYNTHESIS & MANUFACTURING
- DISTILLATION / LIQUID API
- DRYING
- FINE CHEMICAL / INTERMEDIATE
- GMP MANUFACTURING
- HALOGENATION
- HAZARDOUS CHEMISTRY
- HIGH POTENCY APIS (HPAPIS)
- HIGH PRESSURE REACTION (> 100 PSI)
- HIGH TEMPERATURE REACTION (> 200 °C)
- HYDROGENATION
- LOW TEMPERATURE / CRYOGENIC CONDITIONS
- LYOPHILIZATION
- MICRONIZATION
- ORGANOMETALLIC CHEMISTRY
- OZONOLYSIS
- PHOSGENATION
- PLANT EXTRACTION
- PROBIOTIC
- PROCESS DEVELOPMENT & OPTIMIZATION
- PROCESS SAFETY ASSESSMENT
- PROTEIN / PEPTIDE
- REFERENCE STANDARD
- RESOLUTION OF RACEMIC MIXTURE
- SCALE UP
- SEPARATION & PURIFICATION
- SMALL SCALE BATCH
- INJECTABLE / STERILE APIS
- STEROID / HORMONE
- VITAMINS / MINERALS / INORGANIC SALTS
- CHROMATOGRAPHY
- OLIGOSACCHARIDES & POLYSACCHARIDES
- SMALL MOLECULES
- OLIGONUCLEOTIDE / POLYNUCLEOTIDE
- BIOPOLYMERS


01 Custom Synthesis
02 Custom Synthesis
03 Custom Synthesis
04 Custom Synthesis
05 Custom Synthesis
06 Custom Synthesis
07 Custom Synthesis
08 Custom Synthesis
09 Custom Synthesis
10 Custom Synthesis
11 Custom Synthesis
12 Overview
13 Overview
14 Overview
15 Overview
16 Overview
17 Overview
18 Overview
19 Overview
20 Overview
21 Overview
22 Overview
23 Overview
24 Overview
25 Overview
26 Overview
27 Overview
28 Overview
29 Overview
30 Overview
31 Route Scouting
32 Route Scouting
01 Acharya Chemicals
02 Ami Lifesciences Private Limited
03 Anacipher
04 Angelini Pharma
05 Anhui Ribobay Pharmaceutical Co.,Ltd
06 Aozeal Certified Standards
07 Arevipharma
08 Axplora
09 Bachem AG
10 BioSpectra
11 Bioquim
12 CBL- Chemical and Biopharmaceutical Laboratories
13 CPL Sachse
14 CRMO Pharmmatecch
15 CTX Lifesciences
16 Cambrex Corporation
17 Cayman Pharma s.r.o
18 ChemCon GmbH
19 ChemGenix Laboratories Pvt Ltd
20 Chemtos
21 Cohance Lifesciences
22 Curia
23 DOTTIKON EXCLUSIVE SYNTHESIS AG
24 Dalton Pharma Services
25 Diverchim S.A.
26 EUROAPI
27 Evonik
28 Farmhispania
29 Huvepharma Italia S.r.l
30 Inabata France S.A.S
31 Infinium Pharmachem
32 Inke S.A
33 Kekule Pharma
34 LEBSA
35 Legacy Pharmaceuticals Switzerland
36 M2i Group
37 Maithili Life Sciences
38 Malladi Drugs & Pharmaceuticals Limited
39 Menadiona
40 Merck Millipore
41 Metrochem API Private Limited
42 Minakem
43 Neuland Laboratories
44 Olon S.p.A
45 PMC Isochem
46 Pfanstiehl
47 Polfa Tarchomin
48 Polpharma
49 Priyans Drugs
50 Procos
51 Quality Chemicals
52 Quotient Sciences
53 Recipharm AB
54 Robinson Brothers
55 ScinoPharm Taiwan, Ltd
56 Seqens
57 Servier
58 Shanghai Chemspec Corporation
59 Siegfried AG
60 Solara Active Pharma Sciences
61 Stason Pharmaceuticals, Inc.
62 TopChem Pharmaceuticals
63 Valsynthese
64 ZACH System SA
01 Canada
02 China
03 China
04 Czech Republic
05 France
06 France
07 France
08 France
09 France
10 France
11 France
12 France
13 Germany
14 Germany
15 Germany
16 Greece
17 India
18 India
19 India
20 India
21 India
22 India
23 Ireland
24 Italy
25 Poland
26 Poland
27 Singapore
28 Spain
29 Spain
30 Spain
31 Spain
32 Spain
33 Sweden
34 Switzerland
35 Switzerland
36 Switzerland
37 Taiwan
38 U.S.A
39 U.S.A
40 United Kingdom
41 United Kingdom

- Analytical > Analytical Method Development
- Analytical > Analytical Testing Services > Inhalation Products
- Analytical > BioAnalytical Services
- API & Drug Product Development > API Development
- API & Drug Product Development > API Development > Antibody Drug Conjugate
- API & Drug Product Development > API Development > Fine Chemical / Intermediate
- API & Drug Product Development > API Development > High Potency APIs (HPAPIs)
- API & Drug Product Development > API Development > Impurity / Reference Standard
- API & Drug Product Development > API Development > Oligonucleotide / Polynucleotide
- API & Drug Product Development > API Development > Oligosaccharides & Polysaccharides
- API & Drug Product Development > API Development > Overview
- API & Drug Product Development > API Development > Process Development & Optimization
- API & Drug Product Development > API Development > Protein / Peptide
- API & Drug Product Development > API Development > Separation & Purification
- API & Drug Product Development > API Development > Small Molecules
- API & Drug Product Development > API Development > Spray Drying
- API & Drug Product Development > Formulation Development
- API & Drug Product Development > Formulation Development > Buccal / Orodispersible
- API & Drug Product Development > Formulation Development > Capsule
- API & Drug Product Development > Formulation Development > Chewable / Suckable
- API & Drug Product Development > Formulation Development > Clinical Supply
- API & Drug Product Development > Formulation Development > Compounding
- API & Drug Product Development > Formulation Development > Controlled / Immediate / Modified Release
- API & Drug Product Development > Formulation Development > Controlled Substance
- API & Drug Product Development > Formulation Development > Granule / Pellets
- API & Drug Product Development > Formulation Development > Inhalation / Nasal
- API & Drug Product Development > Formulation Development > Injectable / Parenteral
- API & Drug Product Development > Formulation Development > Liquid Formulation
- API & Drug Product Development > Formulation Development > Lyophilization
- API & Drug Product Development > Formulation Development > Ophthalmic
- API & Drug Product Development > Formulation Development > Pediatric Formulation
- API & Drug Product Development > Formulation Development > Scale-Up Capabilities
- API & Drug Product Development > Formulation Development > Sterile Liquid Formulation
- API & Drug Product Development > Formulation Development > Suspension
- API & Drug Product Development > Formulation Development > Tablet
- API & Drug Product Development > Formulation Development > Topical
- API & Drug Product Development > Preformulation & Material Science > Particle Size Reduction & Micronization
- API & Drug Product Development > Preformulation & Material Science > Polymorph & Crystal Screening
- API & Drug Product Development > Preformulation & Material Science > Solubility Assessment & Enhancement
- API & Drug Product Development > Preformulation & Material Science > Taste Masking
- API Manufacturing > Antibiotic
- API Manufacturing > Antibody Drug Conjugate
- API Manufacturing > Biologics, Bioprocess & Fermentation
- API Manufacturing > Chiral Synthesis
- API Manufacturing > Clinical Supply
- API Manufacturing > Continuous Flow Process
- API Manufacturing > Contract Manufacturing
- API Manufacturing > Controlled Substance
- API Manufacturing > Custom Synthesis & Manufacturing
- API Manufacturing > Cytotoxic Compound
- API Manufacturing > Drying > Spray Drying
- API Manufacturing > Fine Chemical / Intermediate
- API Manufacturing > GMP Manufacturing
- API Manufacturing > Hazardous Chemistry
- API Manufacturing > High Potency APIs (HPAPIs)
- API Manufacturing > Micronization
- API Manufacturing > Oligonucleotide / Polynucleotide
- API Manufacturing > Oligosaccharides & Polysaccharides
- API Manufacturing > Organometallic Chemistry
- API Manufacturing > Organometallic Chemistry > Cyanation
- API Manufacturing > Organometallic Chemistry > Metal Hydride Reduction
- API Manufacturing > Ozonolysis
- API Manufacturing > Process Development & Optimization
- API Manufacturing > Protein / Peptide > Synthesis
- API Manufacturing > Reference Standard
- API Manufacturing > Scale Up
- API Manufacturing > Separation & Purification
- API Manufacturing > Small Molecules
- Clinical Trials > Compliance, Regulatory & Consulting
- Clinical Trials > Packaging & Logistics
- Clinical Trials > Medical Writing & Language Translation
- Clinical Trials > Patient / Investigator Recruitment
- Clinical Trials > Technology / Data / Analytics
- Drug Product Manufacturing > Biologic Drugs
- Drug Product Manufacturing > Capsule
- Drug Product Manufacturing > Capsule > Steroid / Hormone
- Drug Product Manufacturing > Compounding
- Drug Product Manufacturing > Cream / Lotion / Ointment
- Drug Product Manufacturing > Emulsion > Overview
- Drug Product Manufacturing > Gel > Overview
- Drug Product Manufacturing > Granule / Pellet
- Drug Product Manufacturing > Injectable / Parenteral
- Drug Product Manufacturing > Injectable / Parenteral > Overview
- Drug Product Manufacturing > Injectable / Parenteral > Pre-Filled Syringe
- Drug Product Manufacturing > Liquid
- Drug Product Manufacturing > Lyophilization
- Drug Product Manufacturing > Nasal
- Drug Product Manufacturing > Softgel Capsule
- Drug Product Manufacturing > Solution > Overview
- Drug Product Manufacturing > Spray
- Drug Product Manufacturing > Suppository
- Drug Product Manufacturing > Suspension > Overview
- Drug Product Manufacturing > Syrup
- Drug Product Manufacturing > Tablet
- Drug Product Manufacturing > Technologies
- Drug Product Manufacturing > Technologies > Orally Disintegrating Tablets (ODTs)
- Drug Product Manufacturing > Technologies > Taste Masking
- Packaging > Clinical Services
- Packaging > Contract Services
- Packaging > Contract Services > Serialization Compliance
- Packaging > Logistic Services
- Empty Capsules
- Empty Capsules > Clinical Supply
- Empty Capsules > HardGel
- Empty Capsules > Inhalation
- Emulsifying Agents
- Soft Gelatin
- Solubilizers
Overview of custom API manufacturing services, from pre-clinical & clinical manufacturing to commercial manufacturing, offered by CDMOs, CMOs, & CROs.
Q1. What is custom API manufacturing?
Custom API manufacturing refers to the production of desired quantities of pharma APIs, intermediates, fine chemicals, small molecules, reference standards, impurities, and other drug substances. API production is carried out exclusively according to a specified scale, which may include large scale custom API capabilities or commercial scale APIs.
The amounts produced during drug substance custom manufacturing tend to be small, ranging from a few milligrams to about 10 kg or so, and can be carried out in-house or by contract active pharmaceutical ingredient manufacturers. An active pharmaceutical ingredient (API) is any substance or mixture of substances intended to be used as active ingredients in medicinal drug products. Active ingredients have direct effects in the diagnosis, cure, mitigation, treatment, and prevention of diseases.
Pharma APIs and raw materials are often confused due to the similar usage of the two terms, however, raw materials refer to the chemical compounds used as a base for API production. The API production process is not completed in a single step, but rather via several chemical reactions between raw materials. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate.
Intermediates are the building blocks of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates are by-products of API synthesis. Furthermore, these pharmaceutical intermediates are produced during each and every reaction of API synthesis. The intermediates are then used in API production for bulk drugs and also for contract research and development (R&D) purposes by various pharma companies.
Fully integrated contract development and manufacturing organizations offer cGMP API manufacturing services from small scale cGMP contract manufacturing of API to large scale custom API capabilities. Many of the CDMOs and CMOs offer small scale cGMP contract manufacturing of active pharmaceutical ingredients or custom synthesis of small molecules as a contract research project or as a custom synthesis project.
The integrated cGMP API manufacturing services allow small scale cGMP contract manufacturing of APIs, from inception all the way through to clinical custom manufacturing and can even advance to production at a commercial scale. Custom API manufacturing or drug substance custom manufacturing ultimately provides the platform necessary for clients to accelerate time to market for finished dosage forms (FDF).
Various pharmaceutical contract development organizations (CDMOs) can take projects from initial process development and scale-up through final validation and manufacturing at a commercial scale, by applying the appropriate drug manufacturing strategies and custom API manufacturing services. Custom API manufacturing services involve - Manufacturing of High Potent APIs (HPAPIs) or HPAPI custom synthesis, Key Starting Materials (KSMs), Registered Starting Materials (RSMs), key GMP intermediates, commercial scale APIs, etc.
Q2. What are the different capabilities involved in drug substance or API custom manufacturing?
Drug Manufacturing Strategies Involved in API Custom Manufacturing:
Step 1: Physicochemical Studies In this stage of API synthesis, the physicochemical properties of a drug substance are characterized and established. Every drug substance has intrinsic chemical and physical properties which need to be considered before latter drug manufacturing strategies can be conducted at a larger scale.
Physicochemical studies include:
- Selection of suitable drug substance candidates for API production
- Planning API and drug substance custom development & manufacturing processes
- Advancement of analytical development cGMP API manufacturing services
- Assignment of pharma API retest periods
- Synthetic route scouting custom API manufacturing services
Route Scouting & Route Optimization:
Synthetic route scouting, during early stages of process development and drug manufacturing, offers significant benefits by decreasing processing times, reducing the steps involved in process chemistry, improving quality and safety profiles, reducing chemical waste production, and improving scalability.
Route optimization can reduce costs, increase the efficiency of drug substance cGMP manufacturing, increase the safety of drug products, and accelerate the drug substance custom development and manufacturing process altogether.
Custom synthesis and route scouting go hand in hand, lately there has been an increasing trend towards achieving route optimization and all the benefits that the custom API manufacturing service imparts to the pharmaceutical product development process. Contract manufacturers provide such process chemistry, route scouting and route optimization - discovery and development services.
Step 2: Selection of Raw material: Active pharmaceutical ingredient (API) manufacturers take the raw materials, chosen during the early stages of drug substance development, and treat them in a reactor to obtain the required intermediates.
Step 3: Intermediates are purified to obtain individual drug products via sedimentation, filtration, centrifugation, crystallization, etc.
Step 4: Standards- The products that are obtained as a result are checked for their strength. Each pharmaceutical company employs different standards to measure the strength of its API.
Step 5: Physicochemical studies, reactor treatments, and purification are followed by scale-up custom API manufacturing services. Scale up is generally defined as the process of increasing batch sizes. In process scale up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing of commercial scale APIs in a full-scale production CDMO facility.
Q3. What are the key features of cGMP API manufacturing?
Good manufacturing practices (GMP) and to be GMP certified means that the active pharmaceutical ingredient (API) manufacturer has demonstrated a strong regulatory commitment compliant with international GMP standards. The jump to cGMP manufacturing is never simple, producing complex molecules within specification for the first time in cGMP is fraught with potential peril at every turn.
API production has traditionally been done by pharmaceutical companies themselves in their home countries, but in recent years many corporations have opted to outsource manufacturing overseas to various CDMOs and CMOs. All the drug manufacturing strategies from selection of raw materials to commercial manufacturing of pharma APIs are performed under cGMP (current Good Manufacturing Practices) conditions.
GMP is followed to ensure that pharmaceutical products (drug substances or drug products) are consistently produced and controlled according to quality standards and to minimize the risks involved in pharmaceutical production. Key elements of GMP API manufacturing must be clearly defined, agreed and controlled in order to avoid misunderstandings which could result in unsatisfactory products.
Key Elements in GMP API Contract Manufacturing:
- Quality Agreement
- Adherence to manufacturing process
- Supplier Audit
- Release of manufactured product
- Documentation and archive
- Cleaning Validation
- Change control
Q4. What are the key attributes when performing cGMP scale up in custom API manufacturing?
Drug substances are needed for a large number of safety studies and clinical trials. Custom synthesis and manufacturing services to go from preclinical to clinical manufacturing, and finally to commercial manufacturing can be challenging.
It is essential that the drug substance manufacturing process, called scale up, is carried out to produce large quantities of active pharmaceutical ingredients. Additionally, when progressing a drug substance from milligram to kilogram scale, there are various characteristics of the drug substance that can impact formulation and need to be considered prior to implementing scale up.
Pharmaceutical GMP scale-up deals with a subject vitally important to the industry—the procedures of transferring the results obtained via discovery and development services, from laboratory scale to the pharmaceutical pilot unit, and finally to production scale under GMP (Good Manufacturing Practices) conditions.
Laboratory Scale: The early stage development phase, generally 100-1000 times lesser in quantity (milligrams) as compared to the production batch, takes place during the laboratory scale stage of formulation scale-up.
Pilot Plant: It is used to test the behavior of a product during small scale custom API development and manufacturing, before proceeding with large scale custom API capabilities at a commercial scale. Pilot labs often use kilo lab units to achieve low volume, test batches of active pharmaceutical ingredients.
It is also an important stage for hazard identification and toxicity testing of drug products in a quality controlled testing laboratory. The pilot plant stage is where a lab scale formula is transformed into a viable product by using practical custom synthesis services and manufacturing procedures.
GMP Production Scale: The last stage of scale-up (kilogram stage) is the production scale. Production batches are referred to as the 100X batch and this is the scale at which fully integrated contract research organizations, and more importantly contract development and manufacturing organizations, run during routine marketing of products.
Fully integrated contract manufacturers, for API and molecule development, have the custom synthesis expertise to provide GMP scale up services at the laboratory and pilot scale of drug development.
All Suppliers
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Pharma Service : API Manufacturing
API CUSTOM SYNTHESIS & MANUFACTURING

Category : Custom Synthesis & Manufacturing
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API CUSTOM SYNTHESIS & MANUFACTURING

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API CUSTOM SYNTHESIS & MANUFACTURING

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ROUTE SCOUTING & CUSTOM SYNTHESIS

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API CUSTOM SYNTHESIS & MANUFACTURING

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API CUSTOM SYNTHESIS & MANUFACTURING

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CUSTOM API MANUFACTURING SERVICES

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PEPTIDE CUSTOM SYNTHESIS & MANUFACTURING

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API CUSTOM SYNTHESIS & MANUFACTURING

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DRUG SUBSTANCE SYNTHESIS & MANUFACTURING

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OLIGONUCLEOTIDE API CUSTOM SYNTHESIS

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COMPLEX MULTI-STEP ORGANIC SYNTHESIS

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API CUSTOM SYNTHESIS & MANUFACTURING

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MULTI-STEP SYNTHESIS OF SMALL MOLECULES

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CDMO FOR ADVANCED ORGANIC SYNTHESIS

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CUSTOM API SYNTHESIS VIA FERMENTATION

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CLINICAL TO COMMERCIAL MANUFACTURING

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CUSTOM SYNTHESIS AND PROCESS DEVELOPMENT

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CUSTOM SYNTHESIS OF APIs & INTERMEDIATE...

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CUSTOM MANUFACTURING PROJECT EXECUTION

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CUSTOM SYNTHESIS FOR API MANUFACTURING

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CUSTOM SYNTHESIS OF BULK ACTIVES

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CUSTOM PEPTIDE SYNTHESIS & MANUFACTURING

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CUSTOM SYNTHESIS FOR EARLY PHASE

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CUSTOM SYNTHESIS OF PHARMACEUTICAL INTER...

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SYNTHESIS OF SMALL FUNCTIONALISED MOLECU...

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SYNTHESIS OF SMALL FOCUSED LIBRARIES

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CUSTOM SYNTHESIS AND MANUFACTURING

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CUSTOM ORGANIC SYNTHESIS & BIOSYNTHESIS

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NINE cGMP MULTI-TON PRODUCTION PLANTS

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API CUSTOM SYNTHESIS & MANUFACTURING

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NEW SYNTHETIC ROUTES DEVELOPMENT

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CUSTOM SYNTHESIS FOR API MANUFACTURING

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CUSTOM MANUFACTURING OF GENERIC & INNOVA...

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NON-INFRINGING SYNTHETIC ROUTES

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CUSTOM SYNTHESIS FOR API MANUFACTURING

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PROVEN TRACK RECORD IN DESIGNING NEW SYN...

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COMPLEX MULTI-STEP ORGANIC SYNTHESIS

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CUSTOM - CONTRACT MANUFACTURING

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CUSTOM SYNTHESIS & MANUFACTURING

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
79


Pharma Service : API Manufacturing
ROUTE SCOUTING TO FULL PROCESS DEVELOPME...

Category : Custom Synthesis & Manufacturing
Sub Category : Route Scouting
Pharma Service : API Manufacturing
80


Pharma Service : API Manufacturing

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
81


Pharma Service : API Manufacturing
CUSTOM PURIFICATION & SYNTHESIS

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
82


Pharma Service : API Manufacturing
EMULSION OR SOLUTION POLYMERIZATION SYNT...

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
83


Pharma Service : API Manufacturing
ELECTRONIC CHEMICALS SYNTHESIS

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
84


Pharma Service : API Manufacturing
CUSTOM SYNTHESIS AND MANUFACTURING

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
85


Pharma Service : API Manufacturing
GMP FRIENDLY ALTERNATIVE SYNTHETIC ROUTE...

Category : Custom Synthesis & Manufacturing
Sub Category : Route Scouting
Pharma Service : API Manufacturing
86


Pharma Service : API Manufacturing
IP PROTECTED SYNTHETIC ROUTES DEVELOPMEN...

Category : Custom Synthesis & Manufacturing
Sub Category : Route Scouting
Pharma Service : API Manufacturing
87


Pharma Service : API Manufacturing
CUSTOMIZED MANUFACTURING SOLUTIONS

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
88


Pharma Service : API Manufacturing
DEVELOPMENT OF SYNTHETIC ROUTE OF NEW CH...

Category : Custom Synthesis & Manufacturing
Sub Category : Route Scouting
Pharma Service : API Manufacturing
89


Pharma Service : API Manufacturing
DEVELOPMENT OF ENTIRELY NEW SYNTHETIC RO...

Category : Custom Synthesis & Manufacturing
Sub Category : Route Scouting
Pharma Service : API Manufacturing
90


Pharma Service : API Manufacturing

Category : Custom Synthesis & Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing