Antihistamine & Anti-Allergic APIs: Micronized & Injectable Ophthalmic/Nasal Grades
Antihistamine Active Pharmaceutical Ingredients (APIs) represent a core pillar in the treatment of allergic rhinitis, chronic idiopathic urticaria, allergic conjunctivitis, and severe anaphylactic symptoms. By selectively blocking peripheral histamine $H_1$-receptors, second- and third-generation antihistamines mitigate histamine-mediated vascular permeability, bronchial constriction, pruritus, and mucosal edema without crossing the blood-brain barrier—delivering potent anti-allergic relief without sedation.
At Micro Orgo Chem (MOC), we manufacture high-purity antihistamine and anti-allergic APIs at our WHO-GMP certified facility in Vapi, Gujarat. We specialize in precision Micronized Grades ($D_{90} < 5\mu\text{m}$ for nasal/ophthalmic suspensions and 90 < 10 for fast-dissolving oral films/tablets). Additionally, we provide a validated Injectable Grade processed in aseptic Class 100 environments, featuring strict Bacterial Endotoxin (BET) controls for sterile eye drops, nasal sprays, and parenteral formulations.
Antihistamine Products Portfolio
| ACTIVE PHARMACEUTICAL INGREDIENTS PRODUCTS | ||||
|---|---|---|---|---|
| PRODUCT NAME | PHARMACOPEIAL GRADE | DMF STATUS (Open Part) | DMF STATUS (Close Part) | |
| AZELASTINE HYDROCHLORIDE | IP/BP/EP/JP/USP | AVAILABLE | ||
Global Supply Chain Resilience & Regulatory Assurance
Micro Orgo Chem ensures complete supply chain stability for high-demand anti-allergic APIs. Manufactured at our WHO-GMP certified facility in Vapi, Gujarat, our synthesis lines maintain multi-source raw material security and strict batch-to-batch polymorphic reproducibility. We provide full regulatory documentation—including **Drug Master Files (DMFs), CTD Dossiers, and ICH Stability Data Packages**—empowering our global partners to secure fast approvals across regulated and semi-regulated markets.
Supply Continuity & Regulatory Support
Our Clients
