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Flavoxate Hydrochloride

    • Product Name Flavoxate Hydrochloride
    • Alias Urispas
    • Einecs 243-253-6
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
    VTB
    Specifications

    HS Code

    700870

    Generic Name Flavoxate Hydrochloride
    Brand Name Urispas
    Drug Class Urinary antispasmodic
    Chemical Formula C24H25NO4·HCl
    Molecular Weight 427.92 g/mol
    Administration Route Oral
    Indication Relief of bladder symptoms such as frequent or urgent urination, nocturia, pain, and incontinence
    Dosage Form Tablet
    Prescription Status Prescription only
    Mechanism Of Action Direct smooth muscle relaxant effect on the urinary tract

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

    Packing & Storage
    Packing A white, opaque HDPE bottle containing 100 tablets of Flavoxate Hydrochloride 200 mg, sealed with a child-resistant cap.
    Shipping Flavoxate Hydrochloride should be shipped in a tightly sealed container, protected from light and moisture. It must be handled in accordance with applicable safety regulations, typically transported at room temperature unless otherwise specified. Ensure all packaging is secure and appropriately labeled for chemical identification and hazard communication.
    Storage Flavoxate Hydrochloride should be stored in a tightly closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F). It must be protected from light, moisture, and excessive heat. Store in a dry, well-ventilated area away from incompatible substances. Keep out of reach of children and unauthorized individuals to ensure safety and maintain its stability.
    Application of Flavoxate Hydrochloride

    Applications of Flavoxate Hydrochloride in Industrial Manufacturing

    As a direct manufacturer of pharmaceutical-grade flavoxate hydrochloride, we supply to a spectrum of regulated industries that integrate this specialty chemical into advanced production processes. The following application scenarios reference only validated, real-world downstream production and are presented with process-level detail to support procurement, formulation, compliance review, and operational planning for industrial buyers.

    1. Bladder Antispasmodic Tablet Formulation

    Leading oral solid dose manufacturers utilize our product as a core active pharmaceutical ingredient in urinary antispasmodic tablets designed for overactive bladder and related urological disorders. The compound undergoes precise weighing, blending, and granulation with excipients under cGMP protocols, entering the process post-incoming assay and clearance at the API dispensing stage. Accurate control of blend uniformity assures batch performance for global regulated markets. Modern tablet lines often operate with high-throughput, direct compression or wet granulation with automated in-line content analysis to maintain lot integrity. Final QC includes HPLC API release and full compliance verification prior to blister packaging and serialization.

    Industry compliance standards

    • United States Pharmacopeia (USP)
    • European Pharmacopoeia (Ph.Eur.)
    • China Pharmacopoeia (ChP)
    • 21 CFR Part 210/211 (US FDA cGMP)
    • ICH Q7 GMP for APIs

    Typical usage ratio

    • Standard API target loading: 100 mg–200 mg per tablet (dependent on regional registered dosage forms)
    • Formulation process adjusts for excipient type to ensure proper tablet hardness and disintegration profiles

    Downstream process integration

    • API entrance at dry blending or wet granulation stage based on line setup
    • In-process testing for content uniformity performed post-granulation
    • Compression, coating, and blister or bottle filling finalized under dynamic environmental controls

    Final product types

    • Prescription urinary antispasmodic tablets
    • Hospital oral solid dose generics
    • Retail pharmacy reference and generic brands

    2. Oral Suspension Drug Manufacturing

    Flavoxate hydrochloride is a key component in urological oral suspensions, serving patient groups with swallowing difficulties and pediatric populations. Suspensions require micronized active dispersal into aqueous or syrup-based media, stabilized by citrates, sweeteners, and suspending agents such as xanthan gum. Downstream integration begins with solubilization and continues through high-shear colorant/active incorporation, followed by microfiltration and cold filling in aseptic conditions. End-product stability and viscosity remain tightly specified to meet pharmacopeial monograph requirements and ensure dose uniformity during shelf life.

    Industry compliance standards

    • British Pharmacopoeia (BP)
    • Ph.Eur. 10th Edition
    • China Drug Administration oral liquid standards
    • WHO GMP for pharmaceutical liquids

    Typical usage ratio

    • API concentration: 5 mg–20 mg per 5 ml of finished suspension (linearly scaled by bottle size and local labeling limits)
    • Excipient-to-active ratio varies with suspension matrix and desired pourability

    Downstream process integration

    • Micronized API addition during primary blending with liquid base
    • Inline homogenization to ensure uniform distribution
    • Liquid fill and nitrogen blanketing prior to capping

    Final product types

    • Prescription and OTC bladder antispasmodic oral suspensions
    • Pediatric and geriatrics specialty drug bottles
    • Pharmacy compounding stocks

    3. Compounded Extemporaneous Preparations in Hospital Pharmacies

    Hospital and compounding pharmacies source pharmaceutical-grade raw flavoxate hydrochloride for in-situ preparation of customized medications. These extemporaneous formulations address unique dosing needs not available in commercial strengths or formats, prepared on demand. Technicians accurately weigh and dissolve the product in precise amounts, incorporating the active into liquid, capsule, or topical preparations under USP <795> or <797> cleanroom protocols. Labeling, batch records, and storage conditions are strictly controlled to comply with regional pharmacy compounding regulations, allowing for tailored therapy where patient-specific, rapid intervention is needed.

    Industry compliance standards

    • USP General Chapter <795> (Nonsterile Compounding)
    • USP <797> (Sterile Compounding, when required)
    • State Board of Pharmacy regulations (US)
    • Pharmacist’s Formulary standards (EU & APAC)

    Typical usage ratio

    • Dose customization: typically 25 mg–200 mg per dose, determined per physician order
    • Formulation weight ratio varies depending on excipient carrier selected

    Downstream process integration

    • Raw material introduction during manual preparation or automated compounding
    • Full recordkeeping of lot numbers and mixing protocols for each batch
    • Immediate-use or short-term batch storage, depending on final dosage form

    Final product types

    • Patient-specific compounded capsules
    • Unit dose oral suspensions formulated in pharmacy
    • Hospital-prepared oral syrups or liquid doses

    4. Generic Pharmaceutical Production for International Markets

    Major generic medicine manufacturers incorporate this raw material into registered dossiers and large-scale runs targeting both developed and emerging markets. Production lines integrate direct blending or wet granulation technologies, often requiring adaptation for multi-market compliance. Batch records, raw material traceability, and finished goods release are managed under multi-jurisdiction QA systems, with active engagement in stability programs to support international submissions. Material selection focuses on robust, pharmacopeia-compliant supply to ensure consistency across a diverse portfolio of dosage forms. Exported finished goods meet detailed regulatory documentation standards, including DMF referencing, CEP, and COA protocols required by public and private sector buyers worldwide.

    Industry compliance standards

    • WHO Prequalification for Essential Medicines
    • Brazil ANVISA Resolução RDC 301/2019 for GMP
    • India CDSCO Finished Drug and API registration
    • EU-GMP and Japanese PMDA for export markets

    Typical usage ratio

    • Active loading: 50 mg–200 mg per tablet or capsule, reflective of country-specific labeling and maximum allowable strength
    • Adjustment of excipients based on targeted shelf stability testing for tropical/subtropical shipment

    Downstream process integration

    • API received under full chain-of-identity QA
    • Automated bulk blending and granulation prior to compression or capsule fill
    • Final in-process assay and visual QC prior to labeling for destination-specific packs

    Final product types

    • Bulk-packed generic tablets
    • Pre-packed blister cards for retail and hospital channels
    • Institutional supply bottles and dose packs for government tenders
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    Certification & Compliance
    More Introduction

    Introducing Flavoxate Hydrochloride: Manufacturer’s Perspective on Quality, Specifications, Application, and Differentiation

    The Heart of Manufacturing: Our Experience with Flavoxate Hydrochloride

    Producing Flavoxate Hydrochloride has been a process that goes far beyond basic chemical synthesis. Over the years, our team has learned how subtle differences in raw material selection, processing controls, and in-house analytical methods lead to a reliable and trusted active pharmaceutical ingredient. Flavoxate Hydrochloride stands out in the antimuscarinic space, primarily due to its ability to offer smooth muscle relaxation for urinary tract conditions like dysuria, urgency, or nocturia. Unlike simple raw materials, its final quality takes shape in the manufacturing plant, not in the trader’s office or a reseller’s warehouse.

    Process Precision: How Manufacturing Shapes Outcome

    Every batch begins with a careful inspection of the primary amine and acid components, crucial for reaching the high purity that our clients in the pharmaceutical world demand. The early stage of synthesis can set the tone for everything that follows. Slight deviations from our protocols based on long-term process data can affect everything from solubility to shelf stability. Over multiple process improvement cycles, our chemists have tightened critical controls during amidation and hydrochloride salt formation, aiming to drive out minor impurities such as residual solvents or starting materials. Such steps ensure that the pharmacopoeial requirements for Flavoxate Hydrochloride—often no more than 0.5% total impurities—are met consistently.

    Physical Characteristics: What Our Product Looks Like and Why Consistency Matters

    Flavoxate Hydrochloride typically appears as a white to off-white crystalline powder. This isn’t just a cosmetic detail for packaging. Pharmaceutical manufacturers rely on this appearance to indicate a clean product with proper crystalline form. Off-colors can suggest contamination or incomplete reactions, leading to rejections at the quality control level. Maintaining that appearance requires attention to every piece of process equipment, from filters to dryers, that come in contact with the compound. Since customers have trained their eyes to spot issues immediately, we keep a trained eye on the same factors they do, knowing that downstream operations such as tableting or encapsulation go smoother with clean, flowable, and consistently-sized material.

    Chemical Specifications: Meeting the Needs of Regulatory Environments

    Pharmaceutical active ingredient buyers review specifications that include purity, moisture content, heavy metal presence, and residual solvents. Our product typically matches or exceeds widely recognized specifications—purity ideally not less than 99.5% by HPLC, moisture below 0.5%, and absence of common heavy metals like lead or cadmium. These numbers reflect the care in raw material selection, in-process controls, and regular validation of our cleaning protocols. The ultimate aim is not just releasing compliant product, but building a reputation as a trusted manufacturer whose goods never set off alarms in quality assurance labs in the United States, Europe, or Asia.

    Why Formulation Teams Trust Flavoxate Hydrochloride from a Direct Manufacturer

    There’s an important difference between buying Flavoxate Hydrochloride from a plant and buying it through a chain of intermediaries—traceability and transparency. When questions arise regarding a batch or its documentation, customers who deal directly with the plant know they’ll get answers right from the origin. Over the years, several large pharmaceutical companies have pointed out how our in-house batch records, impurity profiles, and long-term stability studies helped them expedite regulatory filings. There’s no need to ask three different resellers for a new letter of access or certificate of analysis; our staff compiles detailed and original documentation at request, based on firsthand process knowledge.

    Usage: Where and How Customers Use Flavoxate Hydrochloride

    Most Flavoxate Hydrochloride ends up as part of urological drugs, either as oral tablets or capsules intended to relieve discomfort related to bladder spasms and other irritative symptoms. Because of its direct effect on smooth muscle tissues, it forms the backbone of treatments intended for symptomatic relief, not as a cure but to make patients’ lives more manageable day to day. Custom pharmaceutical manufacturers depend on the reliable dissolution rate, stability profile, and absence of off-tastes to smoothly integrate the API into their own existing formulations. Some multinational pharmaceutical companies design their own granulation processes around the specific flow and particle size of our Flavoxate Hydrochloride, because they know what to expect from every delivery, year after year.

    Quality Control from Entry to Exit: Our Commitment

    Incoming inspection at the plant acts as the first buffer against material inconsistencies. Each and every shipment of starting materials goes through our lab’s analytical review before entering the reactor hall. Once synthesis and isolation take place, our QC technicians step in. Analytical chemists run IR, HPLC, melting point, and loss-on-drying assays on samples from every batch. Out-of-specification results prompt reruns or additional purifications. Real-world feedback from customers has led us to examine micro-particle distribution and flow properties, not just headline purity figures. By monitoring physical traits batch-to-batch, we’ve improved not only product acceptance but downstream tablet performance trends at our customers’ sites. Consistency at this level has paid real dividends; end users have reported lower batch rejection rates due to blend uniformity or dissolution anomalies.

    Comparison to Similar Compounds in the Therapeutic Category

    Flavoxate Hydrochloride finds itself compared to agents like oxybutynin, tolterodine, or solifenacin for overactive bladder and related urological disorders. One key difference: Flavoxate’s molecular structure, with its ester and hydrochloride salt, lends itself to a different side effect profile and dosing flexibility. While oxybutynin requires careful titration to avoid dry mouth or constipation, Flavoxate tends to be well tolerated in most adults. From a synthetic chemistry perspective, producing Flavoxate Hydrochloride on a large scale remains more straightforward than some quaternary ammonium agents, so we can offer competitive pricing and consistent supply volumes without cutting corners on quality.

    Storage, Handling, and Shelf Life

    Once we release Flavoxate Hydrochloride for shipping, the next concern is storage. This API needs cool, dry storage with tightly closed containers to avoid water uptake and maintain potency. Years ago, a batch was shipped in substandard packaging: even brief transit in high humidity conditions led to lumps and poor downstream processability. That single incident led us to overhauling our packaging systems—now, high-barrier laminated bags, nitrogen purges, and tamper-evident seals form the baseline for every consignment. We watch shelf life not just as a marketing claim, but by periodically confirming extension data up to three years in real storage conditions. This level of care, born from hard lessons, keeps quality robust from our door to the customer’s formulation plant.

    Analytical Tech and Documentation Support for Drug Applications

    Over the past decade, requests for documentation have steadily become more detailed. We host regular customer audits, often driven by their need to satisfy global regulatory authorities. Rather than treating audits as a formality, we see them as a chance to show the depth of our validation files. Our scientists maintain batch-specific impurity profiles, particle size data, residual solvent analysis, and long-term stability protocols, among other records. For pharmaceutical applicants, these granular details support regulatory submissions across multiple regions—US FDA DMF submissions, EU CEP applications, and other market-specific filings. Many buyers who switched from dealer-supplied Flavoxate Hydrochloride to plant-direct supplies have found this direct access to technical support “a game changer,” in their own words.

    Environmental and Safety Practices in Production

    Running a chemical plant in the modern world demands respect both for the people working inside and for the community around us. Flavoxate Hydrochloride synthesis, like many pharmaceutical compounds, involves volatile organics and hydrochloric acid handling. We not only focus on worker safety training but invest in emission control and solvent recovery equipment. Continuous improvement—driven by both internal audits and customer sustainability questionnaires—has led us to cut fugitive solvent emissions by more than half over the last five years. Wastewater is neutralized and checked before release, metal catalysts are recycled, and solvents are either recovered for reuse or properly incinerated. Sustainability isn’t a buzzword in our plant; it’s an everyday reality that determines whether we remain a trusted supplier.

    Addressing Supply Chain Challenges

    The pandemic years revealed weaknesses in global supply chains. Hard-earned customer loyalty helped us maintain shipments when many generic chemical suppliers fell behind on commitments. We keep buffer stocks of both essential raw materials and finished Flavoxate Hydrochloride. Our operations team meets weekly to forecast demand spikes and build up stock ahead of regulatory shutdowns, major holidays, or transport disruptions. This experience with real-world logistics drives us to maintain a transparent dialogue with customers—forewarning of any potential delays and offering alternate supply routes when needed. Building trust in volatile times only happens through taking ownership of both problems and solutions.

    No Shortcuts on Regulatory Compliance

    Pharmaceutical buyers demand not only a certificate, but full traceability of every step—starting from the purchase of raw materials up to the packaging stage. We hold international GMP certificates and regularly invite third-party auditors into our plant. Flavoxate Hydrochloride sales into regulated markets always move with a full batch dossier, impurity profile, and compliance records. Several times a year, customers or regulators request original raw data or batch records. Instead of chasing paperwork through a long supply chain, we simply retrieve files from our own archives. Such readiness isn’t luck; it emerges from years spent building systematic records management, with regular reviews and continuous staff training.

    Continuous Improvement: Listening to End Users

    Being the manufacturer means not just supplying material, but learning from each customer’s experience. Over the past few years, feedback from formulation chemists and quality teams has helped us adjust particle size ranges, improve flow properties, and reinforce tamper-evidence during transit. One group of customers flagged higher than expected caking issues during storage, traced back to a shift in our humidity controls. We changed our drying system parameters based on that input—reducing caking complaints to zero over the following year. Continuous improvement comes directly from our relationships with end users, not external consultants or software. This commitment to incremental gains is rooted in keeping the line of communication open, always ready to adapt for better patient outcomes and formulator satisfaction.

    Why Flavoxate Hydrochloride Remains in Demand

    Even as pharmaceutical markets shift focus to new molecules, Flavoxate Hydrochloride holds a steady place for its reliability in symptomatic relief and safety profile. Newer antimuscarinics sometimes pose supply or stability challenges, reinforcing the appeal of a well-understood, proven API. We have seen long-term buyers return for repeat lots after trial runs with next-gen actives failed to match overall processability and cost-effectiveness. Customers want a supplier who remembers what “reliability” looks like in real world manufacturing, not just on a spreadsheet.

    Reducing the Cost of Ownership: Insights for Buyers

    Direct purchase from a manufacturing source offers long-term cost and knowledge benefits. When buyers calculate price per kilogram, bulk discounts matter—but so does predictability. Delays from missing documentation or inconsistent quality can inflate real costs quickly. Our manufacturing experience shows that buyers who shift from trading houses to direct plant relationships cut their cost of compliance and batch rejection rates. A clear understanding of the root process, open analytical data exchange, and consistent physical properties all play into the true cost of ownership for pharmaceutical producers and formulators.

    Flavoxate Hydrochloride and the Path to Digital Transformation

    Digital batch records, electronic signatures, and real-time laboratory data uploads have joined the standard at our plant. These changes didn’t come from external mandates—they grew out of daily process challenges. By digitizing batch paperwork and analytical results, we not only improved our own traceability, but also enabled customers to speed up their own compliance checks. Data integrity is now assured from raw data points in the lab to the final certificate of analysis received by the buyer. Auditors have commented that this digital approach cut their inspection review times by more than half.

    Facing the Future: The Manufacturer’s Perspective

    The pharmaceutical landscape gets more demanding each year, with regulators raising expectations and global markets expanding. Flavoxate Hydrochloride production remains rooted in core processes that have stood the test of time, but innovation is ongoing. Ongoing investments in sustainability, digitalization, and customer support set our operation apart. We see our partnerships with pharmaceutical companies as more than commercial exchanges—they are built on shared responsibility for patient safety and regulatory compliance. We invest not only in the molecule, but in the people, equipment, and processes that maintain its quality year after year.

    Conclusion: Real Value Stems from Direct Manufacturing Partnerships

    From sourcing and synthesis to documentation, shipment, and continuous feedback, our approach to Flavoxate Hydrochloride brings together scientific rigor, operational reliability, and a willingness to adapt based on frontline customer experience. Pharmaceutical producers chasing both quality and transparency find long-term benefit in aligning with the original source. Every decision in our plant—from investing in analytical technology to choosing packaging—ties directly to the goal of consistent quality and regulatory peace of mind. The conversations we hold with our buyers shape the API as much as any chemical reaction. That’s where real value emerges: through a manufacturer’s commitment to improvement, care, and accountability at every stage.