01 APC Ltd
02 AXYNTIS Group
03 Angelini Pharma
05 Aspen API
06 Aurigene Pharmaceutical Services
08 Biophore India Pharmaceuticals Pvt Ltd
09 Bioplus Life Sciences
10 Century Pharmaceuticals
12 DrugOn Pharma Switzerland
13 Eurofins CDMO
14 Extrovis AG
15 Fermion Oy
16 Flamma SpA
18 Hameln rds
19 Huvepharma Italia S.r.l
20 Inke S.A
22 Laboratorium Ofichem B.V
23 Malladi Drugs & Pharmaceuticals Limited
24 Microchem SRL
26 Nanjing Dorra Pharmaceutical Technology Co.,Ltd
27 Neuland Laboratories
28 Ocimum Labs
29 POLYPHARMA TECH & SCIENCES
31 Pfizer CentreOne
32 Phyton Biotech LLC
33 Pierre Fabre
34 Piramal Pharma Solutions
36 Provepharm Life Solutions
37 Recipharm AB
38 SEQUENT SCIENTIFIC LTD
41 Solara Active Pharma Sciences
42 Tianjin Hankang Pharmaceutical Biotechnology
44 Vagdevi InnoScience
Overview of API Custom Development & leading CMOs, CDMOs offering custom synthesis & contract manufacturing services for APIs & Intermediates.
An active pharmaceutical ingredient (API) is any substance or a mixture of substances used in a finished pharmaceutical drug product to provide pharmacological action. Custom API development refers to the production of desired quantities of APIs exclusively on a specified scale as per the customer's requirement.
Drug substance development and manufacturing is the foundation on which pharmaceutical products are built. A company can use either a traditional approach or an enhanced approach to drug substance development, or a combination of both. The amounts produced during the synthesis of APIs tend to be small, ranging from a few milligrams to about 10 kilograms, and this can be carried out in-house or by manufacturers.
Custom development is essential to the pharmaceutical industry as many active pharmaceutical ingredients (APIs) are sometimes very difficult to find or are hard to synthesize. Custom synthesis provides a platform to the clients to accelerate time to market for finished dosage forms (FDF).
The requirements for complex chemicals to facilitate new innovations in drug development pose challenges for all drug development firms. The need for custom drug substance development and manufacturing in the pharmaceutical and biotechnology industries continues to expand.
There are many active pharmaceutical ingredients (APIs), such as small molecule APIs, high potency APIs, small molecules, cytotoxic compounds, biological drug substances and large molecules such as peptides that require complex procedures for their synthesis. Companies prefer to outsource them to contract development and manufacturing organizations and contract manufacturing organizations.
These pharmaceutical companies offer drug substance development services and custom API development and manufacturing along with pharmaceutical drug products. Custom drug substance development companies offer various services, including process and analytical validation, quality control and quality assurance, kilo scale, pilot scale and commercial production. Fully integrated contract development & manufacturing organizations offer drug substance manufacturing and enable the outsourcing of a broad variety of contract development activities from cytotoxic compounds, peptides, biological substance, small molecule drug substance manufacturing to the full scale clinical and commercial manufacturing.
The API development process is a highly challenging task. There are several steps involved in API development and manufacturing and all of them have to be coordinated carefully.
Steps involved in API development and manufacturing are noted below:
Drug development begins with the synthesis of an API and preclinical research to determine the efficacy and safety of the drug. An active pharmaceutical ingredient (API) synthesis process is a related series of operations that results in the preparation of an active pharmaceutical ingredient. A significant part of the quality of the finished pharmaceutical product is dependent on the quality of the active pharmaceutical ingredients (APIs) used in the formulation.
The key factors driving the growth of the active pharmaceutical ingredients (APIs) market are the increasing drug research and development activities for drug manufacturing, the growing importance of generics and the increasing number of biopharmaceuticals. The most important reason in favor of generics is the fact that they are far less expensive to manufacture than their branded counterparts.
Contract Manufacturing Organizations (CMOs) have gained prominence amid the increasing cost of manufacturing drugs and the rise in chronic diseases. API suppliers who can secure their supply chains, from raw materials through to ingredients, are likely to see a considerable increase in demand from pharmaceutical firms.The trend of outsourcing work to CMOs by big pharmaceutical firms is expected to grow in the future, and this will result in a growth in demand for quality APIs.
Proper profiling of your drug is the first step that you should consider before undertaking API synthesis. This includes considering its toxicology, which will have an impact on the facilities required and controls to be put in place to meet all safety and hygiene standards.
The second step is to choose the route that will have the best efficiency. Before starting your experiments, you should first focus on important things like which reagents to use and how to make the process as efficient as possible.
The third step involves preparing for scale-up, which includes at least three kilo scale-up trials of the process while still in the lab, before heading into the far more costly cGMP drug substance manufacturing facility for commercial processing. The last step involves developing a sound synthetic route process. While there are many things to consider and multiple steps to undertake in selecting a synthetic process for a drug candidate, the best CMOs focus on chemical yield, cycle time, number of chemical steps and convergence, etc.
There are various pharmaceutical organizations, such as contract pharmaceutical development and manufacturing organizations (CDMOs) that have the capabilities to offer active pharmaceutical ingredient development or API development services. The leading companies offering custom API development services are mentioned below.
Ofichem - API Development Services
With over 45 years of experience in the production of niche APIs, Laboratory Ofichem develops, produces & distributes APIs worldwide. It can safely & simultaneously produce a broad range of active pharmaceutical ingredients (APIs) for the human & veterinary pharmaceutical markets.
Pfizer CentreOne - API Contract Manufacturing Services
Pfizer CentreOne, a global API contract manufacturing and active pharma ingredient development organization, offers contract manufacturing services for intermediates, small molecules, large molecules and biological drug substances for clinical & commercial manufacturing.
Minakem - HPAPI & API development services
Minakem provides HPAPI development & API contract manufacturing services. Its facility in Louvain-la-Neuve pioneered the utilization of containment technology for the development of highly active pharmaceutical ingredients (HAPI) as well as cytotoxic compounds for clinical & commercial manufacturing.
Polpharma - Active Pharmaceutical Ingredient Development Services
Polpharma provides API contract manufacturing and development services for API synthesis & contract manufacturing services for FDFs. It has compliant and FDA-approved multipurpose facilities which offer an individual approach to each CDMO project.
Phyton Biotech LLC - Plant-based drug substance development services
Phyton offers comprehensive development and API contract manufacturing services for plant-based small molecules, extracts and recombinant products for use in traditional Chinese medicines (TCMs), cosmetics, agriculture as well as food & pharmaceutical industries.
Solara Active Pharma Sciences - Custom API development services
Solara offers contract research, manufacturing & active pharmaceutical ingredient development services across the entire value chain of a new chemical entity, from the preclinical phase to commercial production. It provides drug substance development services with custom active pharmaceutical ingredient (API) synthesis and API integration services.
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With over 45 years of experience in the production of niche APIs, Laboratory Ofichem develops, produces & distributes APIs worldwide. It can safely & simultaneously develop & produce a broad range of APIs for the human & veterinary pharmaceutical markets.
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Pfizer CentreOne, a global contract development and manufacturing organization (CDMO), offers API development and manufacturing services for small molecules, large molecule biologics, specialty APIs, intermediates, etc.
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Minakem offers high-potency active pharma ingredient development & contract manufacturing services. Its facility in Louvain-la-Neuve pioneered the utilization of containment technology for the development of highly active pharmaceutical ingredients/HAPIs.
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Phyton Biotech offers comprehensive development and contract manufacturing services for plant-based molecules, extracts and recombinant products used in traditional Chinese medicines (TCMs), cosmetics, agriculture, food and pharmaceutical industries.
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