Anti-Histamine APIs
Premium Active Pharmaceutical Ingredients for Allergy Relief and Urticaria Treatment
About Anti-Histamine APIs
Holiness Pharmaceutical specializes in manufacturing and exporting high-quality Anti-Histamine APIs for treating allergic conditions. Our portfolio includes first-generation and second-generation antihistamines, including non-sedating formulations manufactured under WHO-GMP standards. We serve pharmaceutical companies worldwide in developing over-the-counter and prescription allergy medications that improve quality of life for millions suffering from allergic rhinitis, urticaria, and related conditions.
Key Features
- WHO-GMP certified antihistamine manufacturing facility
- Compliance with IP, BP, USP, and EP pharmacopeial standards
- Both sedating and non-sedating antihistamine classes
- Advanced chiral synthesis for enantiomerically pure drugs
- Comprehensive impurity profiling and control
- Multiple dosage form specifications available
- Complete regulatory documentation and DMF support
- Technical support for OTC and prescription formulations
Application Areas
Allergic Rhinitis
Relief from seasonal and perennial hay fever, sneezing, and nasal congestion
Urticaria and Hives
Treatment of acute and chronic itching, skin rash, and allergic skin reactions
Allergic Conjunctivitis
Relief from eye itching, redness, and watering due to allergies
Pruritus
Management of itching associated with various dermatological conditions
Anaphylaxis Adjunct
Supportive treatment in severe allergic reactions alongside epinephrine
Quality Assurance
Our anti-histamine APIs undergo comprehensive quality testing including HPLC analysis for purity and related substances, chiral purity assessment for enantiomeric drugs using validated chiral methods, residual solvent analysis, heavy metal testing, and thorough microbiological evaluation. Each batch is certified to meet stringent international standards for allergy medications.
Our Anti-Histamine APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Bromhexine Hydrochloride API | 611-75-6 | IP/BP/EP/USP | API Powder | View Product |
Cetirizine Hydrochloride API | 83881-51-0 | IP/BP/EP/USP | API Powder | View Product |
Desloratadine API | 100643-71-8 | IP/BP/EP/USP | API Powder | View Product |
Fexofenadine HCl API | 153439-40-8 | IP/BP/USP | API Powder | View Product |
Fexofenadine HCl API | 153439-40-8 | IP/BP/USP | API Powder | View Product |
Levocetirizine Hydrochloride API | 130018-77-8 | IP/BP/EP/USP | API Powder | View Product |
Levocetirizine Hydrochloride API | 130018-77-8 | IP/BP/EP/USP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Histamine APIs?
Anti-Histamine APIs are active pharmaceutical ingredients that block histamine receptors, preventing or reducing allergic symptoms like sneezing, itching, runny nose, and hives. They include first-generation antihistamines (sedating) and second-generation antihistamines (non-sedating) that selectively target peripheral H1 receptors without significant CNS penetration.
Which anti-histamine APIs does Holiness Pharmaceutical manufacture?
We manufacture Cetirizine Hydrochloride, Levocetirizine Hydrochloride (active enantiomer of cetirizine), Desloratadine (active metabolite of loratadine), and Bromhexine Hydrochloride (mucolytic with antihistamine properties). All products meet IP, BP, EP, and USP pharmacopeial standards suitable for various allergy formulations.
What is the difference between first and second-generation antihistamines?
First-generation antihistamines cross the blood-brain barrier causing sedation and drowsiness, while second-generation antihistamines are peripherally selective with minimal CNS effects, making them non-sedating. Second-generation drugs like cetirizine and desloratadine are preferred for daily use as they don't impair cognitive function or driving ability.
Why is Levocetirizine more potent than Cetirizine?
Levocetirizine is the active R-enantiomer of cetirizine, while the S-enantiomer has minimal activity. By isolating the active enantiomer, levocetirizine provides equivalent therapeutic effect at half the dose with potentially faster onset and improved receptor binding affinity. We ensure >99% enantiomeric purity through chiral HPLC analysis.
Can your anti-histamine APIs be used in pediatric formulations?
Yes, our anti-histamine APIs are suitable for pediatric formulations. We provide particle size specifications for suspensions and syrups, taste-masking guidance, and technical support for developing age-appropriate dosage forms. Second-generation antihistamines are particularly suitable for children due to their non-sedating nature and established safety profiles.
Do you manufacture APIs for combination cold and allergy products?
Yes, we supply antihistamine APIs for combination products with decongestants, analgesics, or cough suppressants. We provide compatibility data, stability studies in combination, co-processing guidelines, and regulatory support for fixed-dose combination products commonly used in OTC cold and allergy medications.
What dosage forms can be developed with your anti-histamine APIs?
Our anti-histamine APIs support various dosage forms including immediate-release tablets, orally disintegrating tablets (ODT), oral solutions and syrups, extended-release formulations for once-daily dosing, and combination products. We provide technical data including solubility, particle size, and dissolution characteristics for each dosage form.
How do you ensure the stability of anti-histamine APIs?
We conduct comprehensive stability studies under ICH guidelines including long-term, accelerated, and photostability testing. Antihistamines are packaged in moisture-barrier containers with appropriate labeling of storage conditions. We provide stability data supporting 2-3 year shelf life with retest periods. Particular attention is given to protecting from light and moisture which can affect stability.