Neurological & CNS

Betahistine DihydrochlorideThird Party Manufacturing in India

Looking to get Betahistine Dihydrochloride manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
5579-84-0
Drug Class
Histamine analogue (H1 agonist and H3 antagonist)
Molecular Formula
C₈H₁₂N₂ · 2HCl
Molecular Weight
209.12 g/mol
Grade Standards
IP, BP, EP
Therapeutic Category
Neurological & CNS
MOQ
Contact us for MOQ — varies by strength and dosage form
Dosage Forms
Tablet

Mechanism of Action

Betahistine Dihydrochloride works by acting as a strong antagonist at histamine H3 receptors and a weak agonist at histamine H1 receptors in the nervous system to improve inner ear microcirculation.

By blocking presynaptic histamine H3 receptors, Betahistine increases the release of endogenous histamine and other neurotransmitters in the inner ear. At the same time, its agonist activity at postsynaptic H1 receptors induces local vasodilation in the inner ear. This dual action increases blood flow in the stria vascularis and capillary bed of the cochlea and vestibular system. It also reduces endolymphatic pressure (hydrops) and dampens the firing rate of vestibular neurons, which helps stabilize sensory inputs.

Unlike traditional antihistamines that cause drowsiness, Betahistine Dihydrochloride is non-sedating and promotes vestibular compensation to restore balance. It is highly effective and well-tolerated for the management of vertigo and tinnitus associated with Meniere's disease.

Therapeutic Uses & Indications

Therapeutic Uses

Betahistine Dihydrochloride is prescribed for the treatment of:

  • Meniere's Disease: Manages the core triad of symptoms: vertigo, tinnitus (ringing in the ears), and progressive hearing loss.
  • Vestibular Vertigo: Relieves spinning sensations and dizziness caused by inner ear vestibular system disorders.
  • Tinnitus: Reduces persistent ringing or buzzing sounds in the ears associated with labyrinthine disturbances.
  • Peripheral Vertigo: Used to treat dizziness of peripheral origin in adults.

Why Manufacturers Choose Betahistine Dihydrochloride

Betahistine Dihydrochloride is a highly stable, high-demand molecule in the ENT and neurology segments. Vertigo and balance disorders affect a large percentage of the aging population, ensuring a consistent and growing market.

For third party manufacturing in India, Betahistine represents a core product for companies with strong tableting capabilities. Because vertigo treatment requires long-term therapy, patient compliance is highly dependent on formulation quality and the absence of side effects. Sourcing Betahistine tablets from WHO-GMP certified facilities ensures precise active ingredient distribution across lower strengths (like 8mg, 16mg, and 24mg) and uniform dissolution profiles. This high level of quality control is essential for secure registration in export markets and establishing a strong brand reputation domestically.

This makes Betahistine Dihydrochloride one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
8mg · 16mg · 24mg

Frequently Asked Questions

What is the minimum order quantity for Betahistine Dihydrochloride?
Minimum order quantity for Betahistine Dihydrochloride is Contact us for MOQ — varies by strength and dosage form. Please contact us for bulk pricing and custom quantities.
What dosage forms of Betahistine Dihydrochloride can you manufacture?
We manufacture Betahistine Dihydrochloride as: Tablet (8mg, 16mg, 24mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Betahistine Dihydrochloride for export?
Yes. We provide export-ready Betahistine Dihydrochloride formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Betahistine Dihydrochloride?
We manufacture Betahistine Dihydrochloride to IP, BP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Betahistine Dihydrochloride made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines.

Start Manufacturing Betahistine Dihydrochloride Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Betahistine Dihydrochloride across all dosage forms. PCD franchise and export orders welcome.

Need something? Chat with us!