Overview of APIs, Raw Materials, Leading CMOs and CDMOs for Custom Synthesis and Contract Manufacturing of APIs and Intermediates

What is Active Pharmaceutical Ingredient (API) ?

An active pharmaceutical ingredient (API) is any substance or mixture of substances used in a finished drug product to achieve a pharmacological effect. Custom API development refers to manufacturing the required quantity of APIs only at a specific scale according to the customer’s requirements.

Companies can use either traditional or advanced approaches to drug substance development, or a combination of both. The quantities produced by API synthesis are typically small, ranging from a few milligrams to about 10 kilograms, and this can be done in-house or by the manufacturer.

What are Raw Materials & Excipients?

Pharmaceutical raw materials include both active pharmaceutical ingredients (APIs) and inactive ingredients or excipients.

Manufacturers must employ a variety of raw materials in order to develop high-quality medicines. These consist of powders and liquids derived from many substances, including chemicals, minerals, plants, and animals. The kind of material required for a given medicine depends on its intended use. The majority of chemicals used in pharmaceuticals come from natural gas or petroleum resources.

Typically, pharmaceutical raw materials fall into one of the three groups listed below: Pharmaceutically Active Ingredients (APIs) Excipients or inactive ingredients. Raw materials packaging.

What are CMOs and CDMOs?

A contract development and manufacturing organisation (CDMO) and a contract manufacturing organisation (CMO) differ in terms of development. In contrast to CDMOs, which handle both the development and manufacturing of a drug, CMOs are businesses that take a drug that has already been pre-formulated and manufacture it.

Pharmaceutical company Contract Development and Manufacture Organization (CDMO) offers services for both drug development and manufacturing. To outsource medication development and manufacture, pharmaceutical corporations work with CDMOs.

What actions must to be taken into account before starting an active pharmaceutical ingredient (API) synthesis project?

Preclinical research to ascertain the medicine's safety and efficacy follows the synthesis of an API in the early stages of drug development. An associated set of actions that leads to the manufacture of an active pharmaceutical ingredient is known as an active pharmaceutical ingredient (API) synthesis process. The quality of the active pharmaceutical ingredients (APIs) employed in the formulation plays a significant role on the final pharmaceutical product's quality.

The first thing you should do before starting API synthesis is to properly profile your medicine. This includes taking its toxicity into account, which will affect the facilities needed and the controls that need to be put in place to meet all safety and hygiene regulations.

Choosing the route with the most efficiency is the second stage. You should initially concentrate on essential issues like which reagents to employ and how to make the process as efficient as possible before beginning your research.

Before moving into the much more expensive cGMP drug substance manufacturing facility for commercial processing, the third step involves preparation for scale-up, which comprises at least three kilo scale-up trials of the process while still in the lab. The final step entails creating a reliable synthetic route procedure. The finest CMOs concentrate on chemical yield, cycle duration, number of chemical steps, convergence, and other factors even though there are several factors to take into account and numerous procedures to follow when choosing a synthetic process for a drug candidate.

Which are the leading pharmaceutical companies offering API Development contract Services?

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.

Novartis International AG

Novartis International AG, headquartered in Switzerland, provides patented prescription medicines to patients. The company’s Sandoz segment offers active ingredients and finished dosage forms of pharmaceuticals in cardiovascular, central nervous system, dermatology, gastrointestinal and hormonal therapy, metabolism, oncology, ophthalmic, pain, and respiratory areas.

Ofichem – API Development Services

The Ofichem Group manufactures, develops and distributes active pharmaceutical ingredients (APIs) for both the veterinary and human market.

Pfizer CentreOne – API Contract Manufacturing Services

Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) backed by Pfizer resources and a leading supplier of specialty APIs.

TAPI

TAPI (Teva Active Pharmaceutical Ingredients) is one of the leading manufacturers of APIs in the world at present with more than 75 years of experience and around USD 750 million in third party sales. The company presently holds the industry’s largest portfolio of more than 300 APIs.

Minakem – HPAPI & API development services

MINAKEM is a fully integrated development partner (CDMO) and commercial manufacturer of APIs, Highly Potent APIs for pharmaceutical companies.

Polpharma – Active Pharmaceutical Ingredient Development Services

Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs). Highest quality of products and cost-competitive processes.

Solara Active Pharma Sciences – Custom API development services

Phyton Biotech LLC – Plant-based drug substance development services

Phyton Biotech is a pharmaceutical R&D/mfg company specializing in Plant Cell Fermentation (PCF) technology to create drugs that treat cancer & other diseases.