Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. In a biologic drug, the active ingredient is known as a bulk process intermediate (BPI).
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Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma and cancer.
The information provided in the download document is drafted for pharmaceutical executives, research and development (R&D) executives, quality control and quality assurance executives, as well as API manufacturers, distributors, suppliers, sales managers, process engineers, technicians, research associates and production chemists, and any other individuals involved in the operations of the API and active pharmaceutical intermediates industry.
The download contains detailed information on API manufacturers to aid in purchasing decisions, including product ranges and contact details.
Related Buyer&#;s Guides which cover an extensive range of pharmaceutical technologies, equipment, and manufacturers, can also be found here.
APIs are broadly categorised into two types &#; synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used.
Synthetic chemical APIs, also known as small molecules, constitute a large part of the pharmaceutical market, with many small molecule drugs commercially available in the market.
Natural APIs are used in making biologics, which are increasingly becoming the top-selling drugs in the market. Despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.
Based on the solubility, APIs are categorised into insoluble and soluble drugs.
Pharmaceutical Technology has listed the leading suppliers of active pharmaceutical ingredients and intermediates based on its intel, insights and decades-long experience in the sector. The list includes companies that can develop and supply high-quality pharmaceutical materials, including, but not limited to:
The list also includes suppliers of mixing and drying technologies, polymer coatings for drug delivery, extraction technologies for high-purity APIs, and dispersion and wet milling technology. Providers of automatic capsule filling machines, dry powder and liquid-based material handling systems, analytic services for biological assays, pharma tablet manufacturing machines, and custom synthesis services are detailed in the document as well.
Active pharmaceutical ingredients (APIs) are the biologically active components of drugs responsible for producing the desired therapeutic effect. APIs can be synthetic, produced through chemical processes, or derived from natural sources such as plants or animals. The API is combined with other substances, known as excipients, to create the final pharmaceutical product.
APIs are divided into two primary categories: synthetic and natural. Synthetic APIs, which include small molecule drugs, dominate the pharmaceutical market. Natural APIs are used in biologics, such as vaccines and cell therapies, but remain fewer in number.
APIs are classified into soluble and insoluble drugs. Soluble APIs dissolve in bodily fluids, aiding absorption, while insoluble APIs require specialised formulations to ensure effective delivery and absorption within the body.
The guide is used by pharmaceutical executives, R&D teams, quality control experts, and API manufacturers. It provides valuable insights into API suppliers, product ranges, and contact information, helping users make informed purchasing decisions.
Despite challenges such as high manufacturing costs and regulatory hurdles, the API market continues to grow, driven by the rising prevalence of chronic diseases like diabetes, asthma, and cancer. This growth is further fuelled by increasing demand for biologics and advanced therapeutics.
In the intricate landscape of pharmaceutical development and manufacturing, a fundamental understanding of Active Pharmaceutical Ingredients (APIs), intermediates, and finished dosage forms is paramount for professionals in the field.
Each stage is crucial in ensuring efficacy, safety, and regulatory compliance, from the inception of a drug&#;s synthesis to its final formulation.
This guide aims to provide pharmaceutical professionals with a comprehensive overview of APIs, intermediates, and finished dosage forms, delving into their intricacies, and regulatory considerations within the pharmaceutical industry.
APIs constitute the central ingredient of any drug formulation, providing pharmacological activity or other direct effects in disease treatment, prevention, or diagnosis. They are manufactured through chemical synthesis, fermentation, recombinant DNA technology, or isolation from natural sources.
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API Process Development and Production involves several processing stages, such as reaction, crystallisation, separation, purification, filter cake washing, solvent swapping, and solvent exchange.
API Process Development Stage: Following drug discovery and early formulation, scientists determine how to convert the Active Pharmaceutical Ingredient (API) into an appropriate dose form for pilot production. Methods devised during this stage are later scaled up for commercial manufacturing pending successful clinical studies.
Selection of Pharmaceutical Manufacturing Machinery: The choice of machinery for blending, extrusion, drying, milling, and micronization is critical. This selection significantly influences the final drug product&#;s physical characteristics and quality features.
Powder Processing and Particle Size Distribution (PSD): Powder processing involves milling, which reduces particle size for optimal processability, bioavailability, reactivity, and safety. Achieving the suitable particle size distribution (PSD) ensures drug efficacy and delivery to targeted body sites.
API production is a complex process involving chemical synthesis or biochemical methods. According to the FDA, Indian and Chinese companies dominate the API manufacturing sector. Pharmaceutical companies usually adhere to their country&#;s safety standards when manufacturing the final product.
The safety and efficacy of drug products hinge on the quality of their active ingredients, ensured through optimised processes.
Poor API process development and production, along with contaminated active ingredients, are linked to adverse health effects, including fatalities. Thus, regulatory procedures for approving active ingredients are being strengthened globally.
This regulation bolsters the pharmaceutical supply chain, enhancing medication quality and safety. APIs undergo independent pre-qualification processes, ensuring adherence to WHO Good Manufacturing Practices (GMP) and streamlining FPP pre-qualification.
Pharmaceutical intermediates are chemical compounds synthesised and used to produce active pharmaceutical ingredients (APIs). They are formed at various stages in API synthesis and facilitate API synthesis by serving as building blocks or precursor molecules. They undergo chemical modifications to create the desired API.
Intermediates play a vital role in API synthesis by enabling controlled modifications for desired chemical properties. They represent various stages in the synthesis pathway toward the API, contributing significantly to the efficiency, scalability, and quality of the synthesis process. Well-designed intermediates can simplify complex routes, enhance yield, and reduce costs.
For example, a common intermediate in API synthesis is [benzene], which can be modified to produce a wide range of APIs. This versatility is one of the reasons why intermediates are so important in API synthesis.
Pharmaceutical intermediates are subject to GMP guidelines for quality control, compelling manufacturers to establish appropriate systems and processes. To ensure safety and quality, they must identify and control synthesis-related impurities as regulatory authorities require.
Process validation is necessary to maintain consistent quality in manufacturing, with manufacturers obliged to demonstrate process capability to meet specified standards. Additionally, comprehensive documentation is vital for traceability and regulatory assessment, ensuring integrity and compliance throughout the pharmaceutical intermediate manufacturing process.
A finished dosage form (FDF) represents the consumable, finalised drug product. It encompasses tablets, pills, liquid solutions, and other forms of FDFs. All FDFs contain an API along with other inactive components.
There are various types of finished dosage forms, each with unique properties and applications:
The FDA mandates manufacturers to demonstrate the efficacy of medications through laboratory settings and clinical trials involving actual patients. Stricter criteria and inspections have been implemented to regulate medications produced outside the home countries of pharmaceutical corporations.
Understanding APIs, intermediates, and finished dosage forms is pivotal for pharmaceutical professionals. The production of APIs encompasses rigorous processes, impacting the efficacy and safety of drug products from development to manufacturing.
Regulatory compliance ensures quality and safety, with intermediates playing a vital role in API synthesis. Diverse finished dosage forms cater to various patient needs. They are regulated to ensure efficacy and safety. Strengthening regulatory oversight is crucial for maintaining medication quality and safety and safeguarding public health globally.
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