What Is Considered an Active Pharmaceutical Ingredient?

An active pharmaceutical ingredient (API) is any substance or combination of substances in a pharmaceutical product intended to produce pharmacological activity or direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease. APIs are sometimes called bulk active ingredients or drug substances.

What Are Examples of Active Pharmaceutical Ingredients?

Common API examples include: Acetaminophen (paracetamol) – pain/fever reliever (Tylenol’s API) Ibuprofen – anti-inflammatory pain reliever Amoxicillin – antibiotic Metformin – diabetes management Atorvastatin – cholesterol-lowering agent Semaglutide – API in Ozempic for diabetes/type 2 diabetes

What Is API in Pharmaceuticals?

API refers to the pure, active drug substance before it’s formulated with other inactive ingredients (excipients) into a finished product such as tablets, capsules, injections, or syrups. The API is what treats or prevents disease, while excipients help with stability, absorption, and delivery.

What Are Pharmaceutical Services and Active Ingredients?

Pharmaceutical services include API manufacturing, custom synthesis, quality assurance, regulatory support, scale-up, and supply chain management for drug companies. They ensure APIs meet GMP (Good Manufacturing Practices) and regulatory standards. Active ingredients are the core compounds delivered by these services to drug manufacturers worldwide.

What Is the API in Tylenol?

Acetaminophen (paracetamol) is the API in Tylenol—responsible for its pain-relieving and fever-reducing effects.

Where Do Active Pharmaceutical Ingredients Come From?

APIs are manufactured via chemical synthesis, fermentation, plant extraction, or biotechnological processes. They originate from global API manufacturers—major hubs include China, India, the USA, and Europe. Plant-derived APIs are produced by extracting and purifying compounds from medicinal plants.

What Is the Most Common Active Ingredient in Medicine?

Acetaminophen (paracetamol) is one of the world’s most frequently used APIs, found in painkillers, cold/flu tablets, and fever reducers.

Which Is the Largest Producer of Active Pharmaceutical Ingredients?

China and India are the world’s largest producers and exporters of APIs, supplying both generic and patented pharmaceutical companies globally. The USA and Europe are also major manufacturers, particularly for high-value, patented, and regulated APIs.

Can APIs Be Plant-Derived?

Yes! Many APIs are plant-derived, such as: Digoxin (from foxglove, for heart conditions) Paclitaxel (from Pacific yew tree, for cancer) Morphine (from opium poppy, for pain) Botanical APIs are key in both prescription and herbal medicines.

What Is the Active Ingredient in Ozempic?

Semaglutide is the API in Ozempic, a GLP-1 receptor agonist used for type 2 diabetes and, increasingly, weight management.

Vaccines contain APIs—often as biological or protein-based antigens, inactivated viruses, or mRNA—that trigger an immune response rather than treat symptoms. The API in a vaccine is not a traditional small molecule, but rather a biological active substance.

What Is API in Drugs?

API stands for Active Pharmaceutical Ingredient—the component in drugs responsible for their therapeutic action.

What Is a Generic Active Pharmaceutical Ingredient?

A generic API is an active ingredient with the same chemical composition as its brand-name equivalent but produced after the original patent expires. It must meet all quality, efficacy, and regulatory standards for FDA approval.

Who Are the API Suppliers in the US?

Top US API suppliers include: Pfizer CentreOne Cambrex BASF Lonza Siegfried USA Mountainside Medical Equipment Specialty biotech firms and custom API manufacturers support domestic and global supply.

What Are Biological Active Pharmaceutical Ingredients?

Biological APIs (biologics) are large, complex molecules produced by living cells or organisms. Examples include insulin, growth hormone, monoclonal antibodies, vaccines, and recombinant proteins. They differ from small-molecule chemical drugs.

What Is Another Name for an Active Pharmaceutical Ingredient?

Drug substance Bulk drug Active ingredient Bulk active These terms all refer to the pharmacologically active component of a medicine.

Key Features & Industry Benefits

High-purity, GMP-compliant APIs for every therapeutic class Supports brand-name and generic drug manufacturing Small molecule, biological, synthetic, and plant-derived APIs Global supply chains with regulatory support Custom synthesis, scale-up, and documentation for FDA/EMA

Active Pharmaceutical Ingredients (APIs)

Explore premium Active Pharmaceutical Ingredients (APIs) for advanced drug formulation and pharmaceutical manufacturing. Our APIs meet strict GMP and FDA standards, ensuring purity, potency, and safety. Ideal for antibiotics, antivirals, analgesics, cardiovascular, oncology, and diabetes medications, our APIs support pharmaceutical research, generic drugs, and innovation. Optimize medicine production, quality control, and efficacy with our trusted, high-quality APIs for top healthcare solutions.

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from $ 195.00

Vitamin E Acetate (DL) USP Liquid For Compounding (API)
Mountainside Medical

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Vitamin E Acetate (DL) USP Liquid for Compounding (API) is used to create tailored formulations for skin and nutritional health. Known for its anti...
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from $ 49.95

Verapamil Hydrochloride USP For Compounding (API)
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Verapamil Hydrochloride USP for Compounding (API) is an active pharmaceutical ingredient used to formulate medications for managing cardiovascular ...
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from $ 250.00

Vancomycin Hydrochloride USP For Compounding (API)
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Vancomycin Hydrochloride USP for Compounding (API) is an active pharmaceutical ingredient used to formulate customized medications for treating ser...
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from $ 46.00

Valine (L) USP For Compounding (API)
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Valine USP is a synthetic amino acid that is used as an active pharmaceutical ingredient (API) in the production of various pharmaceutical drugs. I...
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from $ 68.00

Valacyclovir Hydrochloride USP For Compounding (API)
Mountainside Medical

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Valacyclovir Hydrochloride USP for Compounding (API) is an active pharmaceutical ingredient used to prepare antiviral medications for treating infe...
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from $ 150.00

Ursodiol USP/EP For Compounding (API)
Mountainside Medical

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Ursodiol USP/EP for Compounding (API) is an active pharmaceutical ingredient used to create customized medications for liver and gallbladder condit...
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from $ 75.00

Urea USP For Compounding (API)
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Urea USP for Compounding (API) is an active pharmaceutical ingredient used in topical formulations to treat various skin conditions. Known for its ...
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from $ 225.00

Trichlormethiazide USP For Compounding (API)
Mountainside Medical

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Trichlormethiazide USP for Compounding (API) is an active pharmaceutical ingredient used in the formulation of diuretic medications. It is primaril...
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from $ 325.00

Topiramate USP For Compounding (API)
Mountainside Medical

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Topiramate USP for Compounding (API) is an active pharmaceutical ingredient used to create personalized medications for managing epilepsy and migra...
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from $ 875.00

Tizanidine Hydrochloride USP For Compounding (API)
Mountainside Medical

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Timolol Maleate USP for Compounding (API) is an active pharmaceutical ingredient used to formulate ophthalmic solutions and other medications for t...
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from $ 99.95

Timolol Maleate USP For Compounding (API)
Mountainside Medical

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Timolol Maleate USP for Compounding (API) is an active pharmaceutical ingredient used to formulate ophthalmic solutions and other medications for t...
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from $ 175.00

Tetracycline Hydrochloride USP For Compounding (API)
Mountainside Medical

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Tetracycline Hydrochloride USP for Compounding (API) is an active pharmaceutical ingredient used in the preparation of customized medications to tr...
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from $ 585.00

Terbinafine Hydrochloride USP For Compounding (API)
Mountainside Medical

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Terbinafine Hydrochloride USP for Compounding (API) is an active pharmaceutical ingredient used in the preparation of tailored antifungal medicatio...
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from $ 295.00

Tacrolimus USP (Monohydrate) For Compounding (API)
Mountainside Medical

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Tacrolimus USP (Monohydrate) is an active pharmaceutical ingredient (API) used in the formulation of medications to treat various inflammatory and ...
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from $ 99.00

Sulfasalazine USP For Compounding (API)
Mountainside Medical

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Sulfasalazine USP for Compounding (API) is used in the formulation of customized medications primarily for the treatment of inflammatory conditions...
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Original price $ 150.00

Current price $ 110.00

Sodium Lauryl Sulfate NF For Compounding (API) 500 g
Mountainside Medical

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Sodium Lauryl Sulfate NF for Compounding (API) is a widely used surfactant and emulsifying agent in pharmaceutical formulations. It serves multiple...
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from $ 175.00

Sodium Hyaluronate (Cosmetic Grade) For Compounding (API) **Refrigerated**
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Sodium Hyaluronate (Cosmetic Grade) is a compound used in the cosmetic industry as a skin moisturizer and anti-aging ingredient. When used in skin ...
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from $ 1,400.00

Polymyxin B Sulfate USP (Micronized) For Compounding (API)
Mountainside Medical

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Polymyxin B Sulfate USP (Micronized) for Compounding is an active pharmaceutical ingredient used primarily in the preparation of customized medicat...
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from $ 59.00

Polyethylene glycol 3350 USP (PEG-75) For Compounding (API)
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Polyethylene Glycol 3350 USP (PEG-75) for Compounding is an active pharmaceutical ingredient used to formulate medications primarily intended for t...
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from $ 125.00

Piroxicam USP For Compounding (API)
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Piroxicam USP is a non-steroidal anti-inflammatory drug (NSAID) that is commonly used for compounding purposes. It is used to relieve pain, inflamm...
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from $ 75.00

Pilocarpine Hydrochloride USP For Compounding (API)
Mountainside Medical

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Pilocarpine Hydrochloride USP for Compounding is an active pharmaceutical ingredient used to formulate customized medications for the treatment of ...
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from $ 130.00

Phytonadione USP (Phytomenadione) (Vitamin K1) For Compounding (API)
Mountainside Medical

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Phytonadione USP (Phytomenadione, Vitamin K1) for Compounding is an active pharmaceutical ingredient used to formulate customized medications aimed...
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from $ 145.00

Phosphatidylcholine For Compounding (API) **Refrigerated**
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Phosphatidylcholine for Compounding (API) is a versatile active ingredient used in the formulation of customized medications and supplements. It is...
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from $ 95.00

Pentoxifylline USP For Compounding (API)
Mountainside Medical

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Pentoxifylline USP for Compounding (API) is an active pharmaceutical ingredient used in the formulation of customized medications to improve blood ...
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