Betahistine

Betahistine is a widely prescribed histamine analog used in the treatment of vertigo, tinnitus, and hearing loss associated with Meniere’s disease. Known for its excellent safety profile and high efficacy in managing inner ear disorders, Betahistine has become a mainstay in otolaryngology (ENT) and neurology practices worldwide.

At BluepillExpress, we are dedicated to offering comprehensive third-party manufacturing solutions for Betahistine. With WHO-GMP-certified production facilities, international quality standards, and a focus on customized formulations, we support pharmaceutical brands, hospitals, government health systems, and private label clients in delivering premium Betahistine products globally.

Product Overview

Product Name: Betahistine
Therapeutic Class: Antivertigo Agent / Histamine Analog
Pharmacological Class: Histamine H1 agonist and H3 antagonist

Available Dosage Forms and Strengths:

• Tablets:
  • Betahistine Dihydrochloride 8 mg
  • Betahistine Dihydrochloride 16 mg
  • Betahistine Dihydrochloride 24 mg
• Oral Disintegrating Tablets (ODTs): On request
• Extended-Release Formulations: Available for custom development

Route of Administration: Oral
Packaging Options:

• Blister packs (PVC-Alu / Alu-Alu)
• HDPE bottles for institutional supply
• Carton packaging with multilingual labeling
• Private label and export-ready options available

Therapeutic Uses and Indications

Betahistine is indicated for the management of:

• Meniere’s Disease: Characterized by episodes of vertigo, tinnitus, hearing loss, and a feeling of pressure in the ear
• Vertigo of vestibular origin: Acute and chronic
• Tinnitus management: In cases of cochlear or vestibular dysfunction
• Post-labyrinthitis or vestibular neuronitis
• Motion sickness or balance-related disorders (off-label)

Betahistine improves microcirculation in the inner ear, enhancing cochlear and vestibular function and reducing the frequency and intensity of vertigo episodes.

Mechanism of Action

Betahistine acts through dual mechanisms:

1. H1 Receptor Agonism: Improves blood flow in the inner ear by vasodilation, reducing endolymphatic pressure.
2. H3 Receptor Antagonism: Increases the turnover and release of histamine and other neurotransmitters in the central nervous system, aiding vestibular compensation.

These combined actions restore balance and hearing function and decrease the severity and duration of vertigo episodes.

Pharmacokinetics

• Absorption: Rapidly and completely absorbed from the gastrointestinal tract
• Metabolism: Extensively metabolized to 2-pyridylacetic acid
• Excretion: Primarily excreted in urine
• Half-life: Approximately 3.5 hours, with effects lasting longer due to sustained histaminergic activity

These pharmacokinetic properties make Betahistine suitable for twice- or thrice-daily dosing, with potential for extended-release development.

Why Choose BluepillExpress for Betahistine Manufacturing?

1. WHO-GMP Certified Production Facilities

Our manufacturing infrastructure complies with:

• WHO-GMP
• ISO 9001:2015
• Schedule M (India)
• International pharmacopoeial standards (IP/USP/Ph.Eur)

We operate dedicated cleanroom zones for solid oral dosage forms and utilize modern technology such as:

• High-speed rotary compression machines
• Fluid bed dryers and granulators
• Coating pans and blenders
• Automated blister and bottle packaging lines

2. Custom Formulation Services

Our in-house R&D team supports:

• Custom tablet strength formulation (8 mg, 16 mg, 24 mg, or extended-release)
• Taste-masked ODTs for geriatric use
• Fixed-dose combinations (Betahistine + other agents on demand)
• Innovative delivery systems such as ER/modified-release tablets

We also offer pilot batch development, formulation feasibility analysis, and technology transfer support.

Quality Control and Assurance

At BluepillExpress, each product batch undergoes rigorous testing in our fully equipped quality control labs. Tests conducted include:

• Assay and content uniformity of Betahistine
• Dissolution and disintegration tests
• Friability, hardness, and weight variation
• Stability studies (accelerated and real-time)
• Microbial limit testing
• Residual solvents and heavy metal analysis

All tests are performed in accordance with IP, USP, and BP specifications, and every batch is released only after meeting stringent QA/QC parameters.

Regulatory and Documentation Support

We provide clients with a comprehensive suite of regulatory documentation required for product registration and export:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Free Sale Certificate (FSC)
• Certificate of Origin (CoO)
• GMP and ISO certifications
• Stability data and shelf-life reports
• Common Technical Document (CTD) or ACTD dossiers
• Product specifications and method of analysis (MoA)
• Material Safety Data Sheet (MSDS)

Our regulatory team has experience in handling registrations across Africa, Southeast Asia, Latin America, CIS, and GCC countries.

Private Label and Packaging Services

We provide end-to-end private label solutions, which include:

• Customized packaging design with client logo and artwork
• Multilingual labeling and inserts (Arabic, French, Spanish, etc.)
• Export-compliant barcoding and serialization
• Tamper-evident and eco-conscious packaging materials
• Blister or bottle formats based on market preference
• QR coding and anti-counterfeit security printing (optional)

Our team supports branding for pharmaceutical marketers, hospitals, and institutional buyers, enabling faster market entry.

Export Readiness and Global Logistics

BluepillExpress has a strong track record in the export of Betahistine and ENT formulations to more than 35 countries. We offer:

• Assistance with product registration in importing countries
• Temperature-controlled shipping (if required)
• Coordination with third-party inspection agencies (SGS, Bureau Veritas)
• Regulatory dossier submission support for tender participation
• Efficient freight management via air and sea routes
• Batch-wise documentation for government health departments and NGOs

Whether shipping 1,000 packs or 1 million tablets, we maintain consistency, speed, and full compliance.

Third-Party Manufacturing Process at BluepillExpress

Our process ensures transparency, accountability, and on-time delivery:

1. Requirement Finalization
   • Strength, dosage form, packaging specs, and target country compliance
2. Quotation and Agreement
   • Cost estimates, lead time, and NDA execution
3. Sample Development (if applicable)
   • R&D batch production and evaluation
4. Artwork and Labeling
   • Client-approved designs and multilingual label support
5. Commercial Batch Production
   • GMP manufacturing with real-time monitoring
6. Quality Control and Documentation
   • Release after lab testing, document handover
7. Dispatch and Export Logistics
   • Freight, customs clearance, and client notification

Average Lead Time: 30–40 working days from final artwork and approval

Target Clients and Applications

Our Betahistine third-party manufacturing program serves:

• Generic pharmaceutical companies
• OTC and prescription drug marketers
• Hospitals and clinical institutions
• Medical distributors and pharmacy chains
• International aid and public health organizations

Whether it’s for retail pharmacies, hospital tenders, or global export markets, BluepillExpress provides flexible solutions for diverse business models.

Benefits of Partnering with BluepillExpress

• WHO-GMP certified and globally compliant facilities
• Expert formulation and R&D team
• Transparent and efficient process from development to dispatch
• Customized labeling, branding, and documentation
• Scalable capacity for bulk or niche market needs
• Competitive pricing and full confidentiality guaranteed
• Fast turnaround times and export coordination

Conclusion

Betahistine continues to play a vital role in managing vertigo and balance-related disorders worldwide. As the demand for safe, affordable, and effective ENT medications grows, choosing a reliable manufacturing partner is crucial for success.

At BluepillExpress, we provide customized, compliant, and high-quality third-party manufacturing services for Betahistine. With our global outlook, regulatory strength, and unwavering commitment to quality, we empower our partners to bring life-enhancing medicines to the market efficiently and confidently.