Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing sales7@sinochem-nanjing.com 3389378665@qq.com
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Meclozine

    • Product Name Meclozine
    • Alias Bonamine
    • Einecs 204-593-9
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry sales7@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    419232

    Generic Name Meclozine
    Alternative Names Meclizine, Antivert, Bonine
    Drug Class Antihistamine
    Main Use Prevention and treatment of nausea, vomiting, and dizziness associated with motion sickness and vertigo
    Route Of Administration Oral
    Common Dosage Form Tablets or chewable tablets
    Onset Of Action 1 hour
    Duration Of Action 8 to 24 hours
    Pregnancy Category B
    Prescription Status Over-the-counter (varies by country)

    As an accredited Meclozine factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing The Meclozine 25 mg tablets come in a white and blue blister pack containing 10 tablets, labeled with dosage and manufacturer details.
    Shipping Meclozine is shipped as a pharmaceutical chemical in securely sealed containers to prevent contamination and degradation. It is typically transported at ambient temperature unless specified otherwise. All shipments comply with relevant safety and regulatory guidelines, including proper labeling and documentation to ensure safe handling and delivery to authorized personnel or facilities.
    Storage Meclozine should be stored in a tightly sealed container at room temperature, ideally between 15°C and 30°C (59°F to 86°F). Keep it away from moisture, direct sunlight, and heat sources. Store in a dry, well-ventilated area, away from incompatible substances, and out of reach of children and unauthorized personnel. Avoid freezing and ensure proper labeling at all times.
    Application of Meclozine

    Applications of Meclozine in Industrial Manufacturing

    Meclozine, an established piperazine derivative, finds targeted use in multiple regulated downstream industries. Our manufacturing process delivers consistent quality, supporting integration in pharmaceutical, veterinary, and specialty formulation sectors where compliance and specification control are critical.

    1. Pharmaceutical Oral Solid Dosage Form Manufacturing

    Formulators incorporate meclozine as the active pharmaceutical ingredient in oral solid dosage forms, such as tablets and capsules, for antiemetic applications. The process involves direct blending with excipients, followed by wet granulation or direct compression to achieve consistent bioavailability and dissolution rates. Stability, compatibility with common binders and disintegrants, and adherence to regulatory monograph standards are critical for release to market. Quality control protocols address uniformity, residual solvents, and assay accuracy at every batch stage.

    Industry compliance standards

    • USP-NF (United States Pharmacopeia)
    • Ph. Eur. (European Pharmacopoeia)
    • BP (British Pharmacopoeia)
    • ICH Q7 GMP Guidelines
    • 21 CFR 210/211 (FDA cGMP for pharmaceuticals)

    Typical usage ratio

    • 8 mg per tablet (standard adult strength), adjusted 5–12 mg per dosage unit for different patient groups or regulatory labeling
    • Active content typically 1–3% w/w in tablet blend, depending on excipient load and form factor

    Downstream process integration

    • API charging during pre-mixing before granulation step
    • Dry blending with diluents, binders, and lubricants in high-shear mixer
    • Controlled humidity environments to protect active content stability

    Final product types

    • Antiemetic tablets
    • Chewable anti-motion sickness tablets
    • Capsule dosage forms for travel sickness

    2. Pediatric Syrup and Liquid Suspension Production

    Producers formulate meclozine into liquid syrup or suspension forms, especially for pediatric administration where dosing flexibility and palatability are critical. The compound is solubilized or uniformly dispersed with co-solvents, sweeteners, and stabilizers, followed by homogenization and filtration to ensure clarity and content uniformity. Analytical testing focuses on sedimentation, viscosity, and preservation against microbial growth during shelf-life. Tight batch traceability and allergen control substantiate compliance for children’s pharmaceuticals.

    Industry compliance standards

    • USP Monograph for Meclozine Hydrochloride Oral Liquid
    • ICH Q3C for residual solvents
    • EU Regulation 1907/2006 (REACH) for excipients
    • PIC/S GMP guidelines for liquid dosage forms

    Typical usage ratio

    • Approximately 1 mg/ml to 2 mg/ml, tailored to age-specific dosing protocols
    • 0.5%–1.5% w/v as active content, depending on syrup volume and sweetness matrix

    Downstream process integration

    • Dissolution in heated aqueous media with glycerin or sorbitol base
    • High-shear mixing to achieve clear solution or stable suspension
    • Filling under Class 100,000 cleanroom conditions to prevent contamination

    Final product types

    • Children’s motion sickness syrups
    • Liquid emetic suppressants for pediatric prescriptions
    • Ready-to-drink anti-nausea suspension bottles

    3. Veterinary Injectable Solution Formulation

    Veterinary health producers utilize meclozine in sterile injectable solutions to manage motion sickness and nausea in companion animals. The sterile production sequence includes API dissolution, pH buffering, and terminal sterilization via autoclave or sterile filtration. Monitoring of endotoxin levels, osmolarity, and injection site tolerance is mandated for animal safety. Regulatory approval relies heavily on Good Manufacturing Practices for veterinary medicinal products and region-specific dossiers.

    Industry compliance standards

    • European Medicines Agency (EMA) - Veterinary Medicines Regulation (EU) 2019/6
    • VICH GL9 GMP for Veterinary Products
    • US FDA Center for Veterinary Medicine (CVM) Guidance
    • Japanese Pharmacopoeia veterinary monographs

    Typical usage ratio

    • Formulated 0.5–2% w/v in injectable ampoules
    • Adjusted per ml to suit weight-dosing regimens for small and large animals

    Downstream process integration

    • Mixing with isotonic solutions and buffering agents before terminal filtration
    • Sterile filtration (0.22 micron) prior to ampoule filling
    • Endotoxin testing and sterility validation on each batch

    Final product types

    • Veterinary antiemetic ampoules for dogs and cats
    • Transport-stress injectable solutions for livestock
    • Ready-to-use prefilled veterinary syringes

    4. Antihistaminic Combination Formulations

    Pharmaceutical manufacturers formulate meclozine with other antihistamines to target allergic reactions paired with nausea, particularly in branded multi-functional cold, allergy, or travel medicines. The compounding process requires precise dosage calibration to avoid therapeutic overlap and to balance pharmacokinetics with other actives like pyridoxine or pseudoephedrine. Dual-delivery tablets or combination liquid formulas pass through repeated blending, granulation, and content uniformity checks. Regulatory dossiers must detail every active-ingredient interaction and stability assessment for combination drugs.

    Industry compliance standards

    • Directive 2001/83/EC (EU medicines for human use)
    • US FDA Combination Drug Products Guidance
    • ICH M4 CTD quality guidelines
    • CFDA (China National Medical Products Administration) GB standards

    Typical usage ratio

    • 4–8 mg meclozine per tablet or per 5 ml syrup, paired with 10–25 mg secondary antihistamine
    • Fine-tuned to local pharmacopoeial monograph and labeling requirements

    Downstream process integration

    • Co-blending of APIs with excipients in rotary blenders
    • Tableting or filling performed with specific sequence to maintain API separation during manufacturing
    • Batch reconciliation documentation for every API lot

    Final product types

    • Allergy and motion sickness dual-action tablets
    • Combination travel sickness liquids with antihistaminic action
    • Extended-release cold/flu combination tablets for retail pharmacy
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    Certification & Compliance
    More Introduction

    Introducing Meclozine: A Reliable Solution from the Manufacturing Floor

    Why We Stand by Meclozine

    At our facility, Meclozine isn’t just an output—it’s the result of steady process improvement, bead-by-bead quality checks, and years of experience working with chemists who know these molecules inside and out. We have witnessed this compound’s evolution from a basic antihistamine to a trusted pharmaceutical active. Every batch comes out of reactors that our maintenance team calibrates daily to meet the specs we’ve refined over hundreds of campaigns.

    Meclozine hydrochloride, as we produce it, comes with the expected chemical profile: C25H27ClN2·2HCl. Our production lines yield high-purity, off-white crystalline powder that dissolves easily in ethanol, slightly in water, and not at all in ether. We ship our product with a moisture content consistently under 0.5% w/w and residue on ignition less than 0.2%, pointing to tightly controlled operations rather than theoretical targets. Each sample undergoes repeated HPLC assay, with purity exceeding 99%, before our QC manager signs off. The typical melting range sits in the bracket between 217 and 222°C, which lines up perfectly with international monographs.

    Unlike some batch-made products that bounce between facilities, all our Meclozine is synthesized, dried, milled, and packed inside one campus. We stand behind the chain of custody, and when customers visit, we show them the line, the raw input bins, and the triple-filtration process that cuts down any chance of cross-contamination. Over time, we’ve seen consistency pay dividends—not only in assay values, but in the trust of regular clients who demand on-schedule supply for repeat orders.

    Day-to-Day Uses: What We See on the Factory Floor

    Most applications of Meclozine center around motion sickness and vertigo. We get regular calls from pharma groups blending it into chewable tablets or syrupy liquids, especially for products aimed at children and older adults. The hands-on formulation work makes everything clear: Meclozine’s gentle onset and mild sedative action seem to suit those who need relief for long car journeys or persistent dizziness.

    We’ve watched customers ask for specific particle size distributions, aiming for optimal tablet compressibility and content uniformity. Our technicians blend these grades with microcrystalline cellulose and see uniform dispersal, so tablets stay robust whether formed by direct compression or via granulation. Liquids manufacturers favor our finer sieve-cut, which disperses quickly without unwanted floating specks. Our staff often get involved during customer plant audits, explaining these subtle adjustments and sharing data on stability under different humidity and heat conditions.

    Veterinary pharma processors use Meclozine for similar symptoms in companion animals, favoring stable suspensions that don’t settle out. In export markets where regulatory monographs run strict, our analytical team works weekly to support filings—handing over validated methods for residual solvents, reporting trace metals, and minimizing API loss during downstream processing.

    We sometimes hear from researchers developing new combination therapies. Their interest in Meclozine doesn’t stop at established use—it extends to oncology, rare neurogenic disorders, and even anti-allergic formulations. For them, our ability to provide gram-to-ton orders, coupled with full traceability and compliance paperwork—matters just as much as the chemistry itself.

    What Sets Meclozine Apart Within Our Product Range

    Across our API portfolio, Meclozine holds its own thanks to reliable handling characteristics and a safety margin that supports both OTC and Rx positioning in many markets. Some older antihistamines we manufacture come with stricter handling protocols and frequent customer complaints around dust or static buildup. Meclozine, in contrast, flows easily from hoppers and doesn’t cling to steel or rubber—appreciated by those running high-speed tablet presses.

    The synthesis process for Meclozine is robust yet more streamlined, compared to multi-step, highly sensitive APIs like cetirizine or loratadine, which sometimes present unpredictable byproduct profiles and tricky purification work. Our Meclozine line runs efficiently, with a lower reject rate, fewer reworks, and less need for batch-specific revalidation. Operators need only make small parameter tweaks for batch size or minor excipient differences, rather than major retooling.

    Stability in storage comes up in conversation with customers who worry about active loss during maritime shipment. Through repeated real-world studies, we have seen Meclozine powder maintain potency at 25°C/60% RH for over two years, provided it stays in our double-layer laminated bags—a point of reassurance when vessels are held up at port.

    Some might compare Meclozine to dimenhydrinate, another motion sickness agent. Unlike dimenhydrinate, which combines diphenhydramine and 8-chlorotheophylline, Meclozine’s simpler structure and milder sedative load make it a better fit for users sensitive to drowsiness. Dimenhydrinate often brings on marked sleepiness, sometimes limiting daytime use, whereas Meclozine strikes a middle ground that our pharma partners find easier to dose, especially in pediatric and geriatric products. Most of the feedback we receive highlights improved compliance and lower incidence of CNS side effects.

    Manufacturing Challenges and How We Work Around Them

    Making Meclozine at scale looks straightforward on a flowchart, but the devil lives in process controls. Early on, our operations team faced crystallization inconsistencies, especially in humid seasons, which led to variable particle size and downstream mixing headaches. Precision cooling curves, moisture monitoring, and in-line sieving reduced batch-to-batch variation by nearly 40% over two years.

    Another sticking point has always been residual solvents. Regulatory scrutiny tightened, so in practice, we switched to greener solvents and improved our vacuum drying cycle. This cut methylated impurity traces to low ppm levels—well below limits that top-tier customers demand. During inspections, regulators seem to appreciate full traceability for all these adjustments, since we keep batch logs going back five years.

    Safety matters, too. Meclozine isn’t classified under acute toxicity hazards, but making it means handling precursor amines and specialty chlorinated reagents. We outfit our process area with local exhaust and air monitoring, keep PPE stocked and supervisors on the floor. With each scale-up, tech transfer, or in-process tweak, our lab repeats safety audits and endpoint checks—catching potential risks before they affect our frontline staff or the product itself.

    With each calendar quarter, GMP rules evolve. Customers who export to tougher markets rely on us to provide not only a product that passes spec, but full DMF (Drug Master File) updates, stability data, and exact impurity profiles. Our regulatory staff log every change—from procedural tweaks to new instrument installs—so we’re always inspection-ready and able to back up our claims without hesitation.

    Meeting Market Demands – What Customers Ask For

    Our larger institutional buyers often look for custom packaging solutions—HDPE drums, nitrogen flushed liners, and moisture indicator cards. Many prefer batch sizes of 50 kg, aligned with monthly compression runs or suspension blend schedules. Growing custom requests push us to optimize everything upstream, from mill screen sizes to improved moisture barrier packaging. Our operations staff noticed fewer caking incidents and easier on-site dispensing once these real-world adjustments rolled out.

    Quality audits and country-specific filings require not only a bulletproof API, but full traceability of excipients and solvents. Our documentation team works directly with customers to prepare CoAs, TSE/BSE statements, non-GMO certifications, and full impurity profiles. We’ve built a reputation for quick turnarounds on technical queries—meaning no long wait to resolve a regulatory request or certificate chase that slows down downstream product launches.

    In parallel, the rise in demand for non-sedating antihistamines led some customers to ask whether Meclozine still holds value. End-user feedback underscores this: Meclozine’s effectiveness in motion-related symptoms and mild vestibular disorders keeps it relevant, even as options multiply. Its time-tested nature, gentle onset, and proven track record anchor our clients’ decision to keep it as a mainstay in both single-ingredient and fixed-dose combination products.

    Environmental and Social Responsibility at Work

    In the chemical sector, community and environmental responsibilities mean more than just ticking a checklist. Sourcing raw materials for Meclozine means looking at both purity and ethical footprints. Our purchasing officers vet suppliers not just on cost, but also on responsible disposal practices and audit compliance, ensuring our input chain supports broader sustainability targets.

    Every phase, from reaction through drying to final sieving, generates waste streams. We reduce mother liquor discharge by recycling solvents, minimize utility usage through heat recovery, and send all process effluent for secondary treatment before it enters any public system. Local environmental regulators have walked our plant, inspected sample archives, and periodically test our air and water outputs. Yearly certifications keep us accountable. It’s not optional. Our team holds internal process improvement meetings with a direct line from the shop floor to management, ensuring everyone—from new hires to senior operators—stays aware of both chemical safety and broader social impacts tied to the business.

    Operator safety and fair labor standards count just as much. Our floor teams run on scheduled maintenance, peer safety checks, and ongoing training. Crew leaders step up for ISO audits, safety drills, and emergency response run-throughs. Behind each drum leaving the plant stands a group of individuals who drive process quality with practical experience, not only with numbers on a screen but by understanding the feel and look of each batch.

    Final Thoughts from Our End of the Industry

    We see Meclozine not as a commodity, but as a long-standing collaboration between manufacturing operations, clients, and, ultimately, end-users who trust medications to improve everyday life. Our batch logs bear the evidence of every process tweak, customer audit, and regulatory review we have handled so far. Behind each lot stands an open-door policy—clients visit, walk the lines, and ask questions, pushing us to keep quality both visible and real.

    Meclozine’s ongoing viability in competitive therapeutic spaces owes much to this cycle of feedback, revision, and commitment. As end-use patterns shift, and as new regulatory requirements emerge, we keep improving core processes and train fresh generations of technicians on shop-floor technique. The industry moves, science keeps marching forward, but the fundamentals—safe, clean, reliable manufacturing—stay unchanged.

    None of that is abstract; it’s hours on your feet inside a hot process bay, late-night calibration runs, and frank talks with technical staff over how to solve sampling issues. From procurement to shipping, every link adds up to product integrity. When we put our name behind Meclozine, it comes with years of measurable performance, hands-on experience, and the kind of practical innovation that only comes from daily involvement in every part of the supply chain.