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Diphenhydramine
HCl

Diphenhydramine HCl is suitable for manufacturing a wide variety of pharmaceutical forms

HUMAN API

Diphenhydramine

Diphenhydramine is a foundational Active Pharmaceutical Ingredient (API) belonging to the first generation of Antihistamines. It is distinguished by its triple action: Antiallergic, Sedative, and Anticholinergic, making it a versatile material used in allergy relief, sleep aids, and cold/flu formulations. We supply Diphenhydramine in its Hydrochloride (HCl) salt form to ensure optimal solubility and stability.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
First-Generation Antihistamine and Sleep Aid.
Mechanism of Action:
Inhibits H1 histamine receptors in the CNS and peripheral tissues, reducing the effects of allergy-inducing histamine. It crosses the blood-brain barrier, accounting for its notable sedative effect.
Clinical Application:
Treatment of allergy symptoms (e.g., sneezing, runny nose, rashes), use as a sleep aid (due to its sedative properties), and management of motion sickness symptoms.
Competitive Advantage:
A multi-purpose API used in popular Over-The-Counter (OTC) formulations, broadening market opportunities.
Tablets and Capsules

Immediate-release tablets, compressed capsules, and liquid-filled capsules.

Provides good powder flow and cohesiveness, facilitating high-speed compression and filling processes.

Liquid Formulations

Cough/cold syrups and sleep-aid solutions for children and adults.

The high solubility of the Hydrochloride salt ensures the preparation of clear, stable aqueous solutions.

Topical Preparations

Creams and lotions for relieving itching and insect bites.

Good compatibility with dermal bases for manufacturing effective topical symptom-relief products.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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