Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:

Acamprosate Calcium

    • Product Name Acamprosate Calcium
    • Alias Campral
    • Einecs 274-407-1
    • 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

    291583

    Generic Name Acamprosate Calcium
    Brand Names Campral
    Chemical Formula C10H20CaN2O8
    Molecular Weight 400.45 g/mol
    Drug Class Alcohol dependence therapy agent
    Indication Maintenance of abstinence in alcohol-dependent patients
    Route Of Administration Oral
    Dosage Form Tablet
    Typical Adult Dose 666 mg three times daily
    Mechanism Of Action Modulates glutamatergic and GABA neurotransmission
    Contraindication Severe renal impairment
    Common Side Effects Diarrhea, nausea, depression
    Pregnancy Category C
    Half Life 20-33 hours
    Storage Conditions Store at 20°C to 25°C (68°F to 77°F)

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

    Packing & Storage
    Packing Acamprosate Calcium is packaged in a sealed, amber glass bottle containing 100 grams, labeled with product details, batch number, and expiration date.
    Shipping Acamprosate Calcium is shipped in tightly sealed, moisture-resistant containers to prevent contamination and degradation. Packaging complies with standard chemical handling and transportation regulations. The product is labeled according to regulatory requirements and is shipped at ambient temperature, unless specified otherwise, ensuring safe and stable delivery to the designated address.
    Storage Acamprosate Calcium should be stored in a tightly closed container, protected from moisture and light. Keep it at room temperature, typically between 20°C and 25°C (68°F to 77°F). Store in a dry place, away from incompatible substances and out of reach of children. Avoid exposure to excessive heat and humidity to ensure chemical stability and effectiveness.
    Application of Acamprosate Calcium

    Applications of Acamprosate Calcium in Industrial Manufacturing

    As the direct manufacturer of Acamprosate Calcium, we deliver pharmaceutical-grade raw materials to partners engaged in specialized downstream processing. Our focus remains on supporting the core medical and related fields where this active pharmaceutical ingredient underpins regulatory-approved finished goods. The following application sectors reflect real-world integrations of Acamprosate Calcium based on validated manufacturing processes, governed by region-specific compliance and quality controls.

    1. Prescription Medication Production for Alcohol Dependence Therapy

    Licensed pharmaceutical manufacturers incorporate Acamprosate Calcium as the primary active ingredient in the formulation of oral tablets designed for alcohol dependence therapy. The ingredient enters the tableting process in accordance with pharmacopeial specifications, requiring stringent handling to maintain stability and dose accuracy. The formulation’s critical parameter revolves around maintaining a steady drug release profile, necessitating precise blending and granulation with excipients under GMP environments. Each production batch undergoes validated analytical testing to confirm purity, potency, and absence of contaminants before tableting and final packaging.

    Industry compliance standards

    • European Pharmacopoeia (Ph. Eur.) Monograph 01/2016:2498
    • United States Pharmacopeia (USP) Monograph
    • ICH Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients
    • WHO GMP for Finished Pharmaceutical Products

    Typical usage ratio

    • Approximately 300 mg per tablet, with dosing tailored by regional health authority approvals. Formulation commonly involves 20–40% w/w Acamprosate Calcium relative to total tablet mass, adjusted for tablet strength and excipient profile.

    Downstream process integration

    • Direct addition during powder blending, followed by wet or dry granulation, compression, and coating steps under controlled environmental conditions.

    Final product types

    • Film-coated tablets in blister packs
    • Bottled tablets for outpatient dispensing
    • Hospital bulk packs for clinical use

    2. Development of Generic Drug Formulations

    Contract development and manufacturing organizations (CDMOs) utilize Acamprosate Calcium supplied with full traceability for the formulation of generic equivalents to patented alcohol abstinence drugs. The material’s chemical consistency and analytical profile must align with reference-listed drugs for bioequivalence studies. During scale-up, rigorous in-process controls verify blend uniformity and dissolution rates, while regulatory dossiers necessitate detailed source documentation and certificates of analysis. Finished dosage forms often undergo stability trials in accordance with ICH guidelines before market release.

    Industry compliance standards

    • US FDA 21 CFR Part 314 (ANDA Submission)
    • European Medicines Agency (EMA) Guideline on the Investigation of Bioequivalence
    • GMP Certification (ISO 15378)
    • Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide

    Typical usage ratio

    • Parallels reference product label claim: 333 mg per tablet or caplet. Ratio to excipients is product-specific, ranging 18–35% w/w, optimized during formulation development to match dissolution and pharmacokinetic profiles.

    Downstream process integration

    • Introduced during initial formulation blending in R&D labs, then scaled for mass production with in-line particle size testing and environmental monitoring to safeguard batch reproducibility.

    Final product types

    • Generic coated tablets for retail pharmacy channels
    • Hospital-labeled generic packages
    • Patient adherence starter kits

    3. Clinical Trial Supplies Manufacturing

    CROs and clinical supply manufacturers employ our material for the preparation of blinded or open-label investigational medicinal products (IMPs) in accordance with clinical protocols. Each batch undergoes QA and QC batch release procedures, ensuring compliance with investigational drug supply chain integrity and GCP-linked documentation requirements. The precise lot-specific identity of Acamprosate Calcium must be traceable through randomization and packaging stages for clinical site distribution.

    Industry compliance standards

    • Good Clinical Practice (ICH E6)
    • EU Clinical Trial Regulation (CTR) 536/2014
    • US FDA cGMP for Phase I Materials (21 CFR 210/211 exemption for investigational use)
    • Annex 13 – Manufacture of Investigational Medicinal Products (EU GMP)

    Typical usage ratio

    • Aligns with approved clinical research protocols, most commonly 300–333 mg Acamprosate Calcium per IMP unit. Proportion versus excipients is determined by study-specific pharmacokinetic modeling.

    Downstream process integration

    • Added during GMP-compliant blending for clinical lot preparation, with segregation between placebo and active arms to guarantee blinding integrity.

    Final product types

    • Blinded clinical doses in sealed containers
    • Open-label tablet vials for investigator-initiated trials
    • Patient kits for subject use during dosing phases

    4. Reference Standard Production for Analytical Laboratories

    Certified reference material (CRM) producers require Acamprosate Calcium as a raw analyte for development of high-purity working standards deployed in pharmaceutical QC labs. Rigorous purification, sub-batching, and homogeneity assessment precede fill-finish into ampoules or vials, with cross-validation to pharmacopeial standards. Our lot-specific supply enables downstream users to prepare calibration curves for HPLC, LC-MS, or UV analysis, underpinning regulatory batch release and stability testing for commercial drugs.

    Industry compliance standards

    • ISO 17034:2016 General Requirements for the Competence of Reference Material Producers
    • ISO/IEC 17025:2017 Laboratory Accreditation
    • USP Reference Standards Program Guidelines
    • European Pharmacopoeia Reference Standard Framework

    Typical usage ratio

    • Processed in pure analyte form; final CRM ampoule contains precisely quantified content, usually 10–100 mg per vial, defined by downstream customer’s method validation needs.

    Downstream process integration

    • Receives additional analytical validation, dilution, and sterile filtration prior to ampoule/vial filling for distribution to analytical testing laboratories.

    Final product types

    • Certified reference standards (CRS) vials
    • Analytical quality control ampoules
    • Secondary working standards for manufacturing QC
    Free Quote

    Competitive Acamprosate Calcium prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: admin@sinochem-nanjing.com

    Get Free Quote of Sinochem Nanjing Corporation

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Acamprosate Calcium: Our Perspective as a Chemical Manufacturer

    Deep Roots in the Synthesis of Acamprosate Calcium

    Moving away from surface introductions, let’s get into what matters: producing Acamprosate Calcium takes careful control from the earliest steps of synthesis to final packaging. Our team has spent years refining each detail in the process, from raw material sourcing to crystallization, filtration, and drying. Careful pH adjustment, precise temperature management, and filtration shape the product’s final purity and consistency. We learned through hands-on experience that even small lapses bring about variations in particle size and yield, both of which impact downstream formulation. Regular feedback from formulation teams has proved vital; they push us to tighten controls and continually enhance reproducibility. Our engineers and chemists work side by side, addressing each challenge—clumping in drying beds, inconsistent salt forms, or trace impurities—by tweaking process steps rather than patching symptoms. Reliable Acamprosate Calcium manufacturing always means being ready to recalibrate, never assuming a one-size-fits-all method works for all batches. We understand that in medication manufacturing, predictability in every single batch trumps sheer output volume.

    Model and Specifications—Shaped by Experience, Not Just Numbers

    Acamprosate Calcium carries the chemical name calcium acetylhomotaurinate. In our operation, we focus on very specific batch-to-batch specs demanded by pharmaceutical applications. A typical batch targets a calcium content of 13.0–14.0%, moisture under 5%, and purity over 98.5%. Achieving these numbers is more than ticking boxes. During the synthesis, calcium levels can drift as a result of raw calcium source variability. Early on, we used to see more deviation between batches until we tightened supplier controls and introduced more intermediate testing. Water content, often overlooked as trivial, needs constant attention during the final drying stage—residual moisture can affect flow properties, shelf life, and even blending for tablet production. Each specification serves a practical purpose developed after years in the trenches: the focus on bulk density grew out of direct conversations with tableting engineers frustrated by inconsistent fill weights. White to off-white powder may seem like a small detail, but visual clues save hours troubleshooting flow and purity problems down the line.

    Particle size matters much more than the uninitiated often realize. Our QC labs measure for D90 under 60 microns, because this grade supports immediate-release and extended-release tablet forms without clumping or sticking during blending. Good flow properties cut down on production stoppages—something our customers appreciate and something we track closely ourselves. Grades for injection or solution require even stricter particle uniformity and tighter microbial limits; those demands reach further back into process design, influencing not just filtration, but every step from recrystallization to packaging.

    Why Pharmaceutical Grade Production Can’t Rely on Luck

    People unfamiliar with the hands-on aspects of chemical manufacturing often assume high purity comes as a given, but every lot is a test of systems in place. We respond to regulatory and pharmacopeial requirements like USP and EP—these aren’t just boxes to check but ongoing conversations with real consequences. Auditors and client QA teams visit us to scrutinize documentation, batch records, and laboratory notebooks. We aim for transparency by recording every deviation, every new trend observed in chromatography results, every change in cleaning cycle frequency. Failures or even near misses aren’t swept under the rug but studied in postmortems to identify true causes. This level of rigor exists because small impurities, left unmanaged, spell trouble in downstream tableting processes and patient safety. Allergen, microbial, and elemental impurities—lead, cadmium, arsenic—get monitored on every batch. We’ve had to retire old stainless tanks and overhaul air-handling units in response to trace metal spikes. No shortcut or luck gets a batch to meet all ATP (acceptable test parameter) limits every time; process discipline and well-trained staff create dependability.

    Within our facility, air handling and zone segregation gain as much attention as the reaction kettles themselves. We separate synthesis and packing lines physically, using positive airflow and regular swabbing to minimize cross-contamination from earlier steps or neighboring lines producing unrelated substances. Acamprosate Calcium doesn’t tolerate heavy metal cross-contamination; even minuscule traces drift into measurements. If our environmental monitors pick up more than 2 ppm, we mobilize teams to deep clean and retest until the issue resolves. The production floor isn’t just about chemistry—it’s about routine.

    Addressing Bulk Handling Challenges Unique to Acamprosate Calcium

    Large-scale chemical production throws curveballs often missed in lab-scale trials. Acamprosate Calcium, with its hydrophilic nature, wants to pick up moisture from air, agglomerate, and create compacted lumps inside drums. This tendency frustrated us for years, leading to in-process blockages, unplanned downtime, and uneven blending downstream. Making excuses didn’t help—spending extra to rework sticky batches or pass them through a mill after drying never matched batches handled well from the get-go.

    By rebuilding our drying and storage protocols, we found better consistency. Sealed containers and low-humidity rooms keep most of the trouble out. Hoppers and bulk transfer lines received PTFE linings to prevent bridging and caking. All of this came about by listening to feedback from packaging operators and downstream customers, not just relying on textbook instructions. It’s the small changes—improved gaskets, a shorter interval between drying and packing—rather than grand overhauls, that made the most measurable difference.

    Acamprosate Calcium in Formulation

    The product matters most where it’s used. Our formulator clients, whether they blend tablets or make powder for suspension, care deeply about the product behaving consistently. Specifically, moisture, flow, and mixing properties must repeat themselves every time. Early production runs that failed to mix evenly led to variable dosage forms, which forced us to address the smallest sources of error before releasing any batch. The need for rapid dissolution in water-based media means we monitor for not just chemical purity but also physical form: too many large particles slow dissolving and complicate homogeneity. Inconsistencies in appearance serve as an early warning system in our facility, not just a cosmetic issue.

    Some formulators use Acamprosate Calcium as it is, others micronize it for even finer distribution. We see a trend toward ready-to-use, granular grades as a way to streamline production logistics, reducing dust in the air and the need for additional onsite size reduction. Each customer draws on the material’s surface area, wettability, and density for slightly different endpoints. Our feedback loop—inviting clients onsite, running pilot tests, sharing lab notes—drives ongoing process changes. Without close contact with formulation partners, half of the quirks in downstream mixing and compaction would surprise us later. Listening and refining keeps our product matching the expectations and strict standards required for regulatory filings and ongoing commercialization.

    Comparing Acamprosate Calcium to Similar Molecules

    Chemical manufacturers habitually field questions about why one compound is chosen over another. Acamprosate Calcium, unlike naltrexone, disulfiram, or baclofen, addresses alcohol dependence by targeting the brain’s glutamatergic system—reducing post-acute withdrawal symptoms through a different mechanism than opioid antagonists or GABA derivatives. We don’t dabble in mechanism speculation, but we hear from research partners that Acamprosate’s pharmacological nuances lend it an important place alongside, and not merely in place of, alternatives. From our side of the business, this means increased documentation and supply chain oversight. Unique regulatory reporting obligations attach to every batch, especially when a molecule occupies a distinct pharmacological niche.

    From a production perspective, Acamprosate Calcium doesn’t present the same hazards as disulfiram, which involves reactive intermediates. Our plant teams monitor batch records closely, but the steps governing Acamprosate’s synthesis remain more routine, so long as the environment remains clean and the controls tight. In contrast, other products might use more hazardous solvents or catalysts, requiring extra containment and emergency planning. Handling Acamprosate demands mostly vigilance against trace impurities and moisture, rather than significant toxicology or explosion risks. This makes Acamprosate attractive for continuous manufacturing, as the line switching and environmental cleanout routines don’t require as heavy a hand.

    There are subtleties even within Acamprosate that aren’t immediately apparent until scale-up. Different salt forms appear in literature and small-batch suppliers—yet only the calcium salt finds broad regulatory acceptance and meets the needs of major pharmaceutical programs. Acamprosate magnesium or sodium species may offer theoretical advantages in solubility, but regulatory and clinical inertia favors calcium. Our own research into alternate salts reveals formulation headaches outweigh gains in dissolution rates or taste masking. We’ve learned to focus on what works repeatedly on scale, in batch after batch, where the smallest instability snowballs into major costs during distribution and shelf life studies.

    Quality Control With an Operator’s Mindset

    Checking boxes on quality control protocols never stands in for hands-on vigilance. The trained eyes of our operators catch abnormalities quickly: off-color powder triggers an immediate investigation; sudden caking or drop in pH gets flagged well before automated alarms. Our lab teams pull samples at every step, comparing against historical data, identifying trends in impurity peaks, and recalibrating analytical equipment when drift appears. Dissolution testing isn’t just a regulatory hurdle—it’s a regular rehearsal for what end users will experience in real-world formulations.

    Our system for batch tracing lets us link every kilogram of Acamprosate Calcium back to the raw material lot, shift, operator, and blending run. This system doesn’t just protect us—it reassures customers and enables troubleshooting when a downstream deviation arises. Failures occur, not from negligence but from real-world complexity, and a manufacturer’s reputation grows from admitting errors, retracing steps, and preventing repetition. It’s not enough to read a certificate of analysis; direct involvement in the process uncovers practical issues before they escalate.

    Sustainability and Practical Impact

    We operate under the constant scrutiny of environmental responsibility. Wastewater from Acamprosate Calcium production, loaded with trace organics and low-level calcium, used to require off-site disposal at high cost. Over time, we invested in in-house neutralization and filtration; this step not only reduced our spend, but lessened the community impact. Some solvents used in earlier steps now get recycled through distillation columns rather than disposed outright. The main motivator for these changes was not abstract environmentalism, but direct cost and regulatory inspection pressure. Now, we find customers ask about carbon footprint and local water impact as often as they query assay results. Transparent reporting on waste streams and continuous process improvement calm regulatory nerves and open export doors, particularly in regions with strict compliance standards. As a manufacturer, skipping these investments seems short-sighted: responsible stewardship of byproducts and waste ensures long-term viability as much as price or turnaround time.

    Supply Chain Risks and Reliability

    COVID-era logistics jolted the chemical industry, save for those rooted in flexible, local raw materials. Overseas lockdowns and shipping container backups delayed key intermediates, and Acamprosate Calcium production slowed in some plants. Ours kept going, largely because we drew supplies from closer, vetted partners and maintained standing inventories—even when cost savings tempted us offshore. In an age of global volatility, supply assurance demands local relationships, higher working inventories, and honesty in lead time commitments. While traders and brokers can smooth shortfalls temporarily, only those directly involved in production can fix issues before raw material gaps become lost batches.

    We also invest in redundancy: dual qualified suppliers for calcium carbonate, multiple testing labs vetting intermediates, and contingency plans for transportation. Each month we review potential bottlenecks and seek ways to reduce single points of failure. No amount of contractual protection substitutes for direct oversight and a buffer stock strategy—hard-learned advice for any manufacturer aiming to survive regulatory and market shocks alike. Knowing what could go wrong shapes day-to-day practice more than just quarterly profit or loss tallies.

    How Our Team Shapes Product Quality

    No manufacturer succeeds on equipment and procedures alone. We invest in the ongoing education of our operators, QC chemists, and maintenance crews. Direct exposure to customer feedback, regular process audits, and team rotations through the plant foster a culture where staff see daily how their attention to detail links to customers’ final product quality and safety. Several of our long-term staff began careers on the packaging line; their advice reshaped protocols that now shave hours off changeovers or reduce dust exposure across the warehouse. Solutions come as much from within the team as from outside consultants.

    Operator training goes beyond routine: we simulate failures, bring in adverse event scenarios, and review real-world recalls from across the industry. Our plant remains ready not just for regular runs, but for problems that appear without warning. It builds confidence and adaptability—and most of all, accountability, across shift changes and generations of staff. The early culture of “good enough” rarely survives client audits; those who stay long in this business develop the discipline it takes to exceed minimal compliance and aim for excellence in each batch.

    Feedback Loops for Quality Improvement

    No regulatory checklist ever builds product quality as well as detailed feedback from formulators, equipment operators, or regulatory reviewers. Our relationship with Acamprosate Calcium buyers includes rapid response to quality incidents, root cause analysis, and iterative process improvement in partnership with clients. Open invitation for third-party audits, transparency in deviation reporting, and willingness to share “bad news” have drawn stronger relationships with buyers and regulatory agencies alike. We keep a priority list drawn from direct feedback—whether packaging integrity, labeling clarity, or changes to desiccant capsules—and use it to shape daily operations.

    Any deviation in performance—whether a blending problem at a client’s site or a shelf life anomaly—triggers a full-circle investigation. We treat each as a source of learning, cataloging real lessons rather than brushing off outliers. Over time, what appears as routine—tighter moisture management, improved container seals, or faster swab tests—accrues meaningful gains in product robustness. No committee or outside consultant would engineer exactly these solutions without the context given by real-world production and user experience. Acamprosate Calcium owes its current quality to decades of these hard-won, incremental improvements rather than any single innovation or executive decision.

    What Sets Manufacturer Experience Apart

    It’s easy to forget that behind every lot of chemical delivered, people and processes have wrestled with variables impossible to see on a safety data sheet. Acamprosate Calcium manufacturing involves daily observation, routine adjustment, and a willingness to document and revisit every misstep. Major pharmaceutical clients and generic drug makers only return if traceability, reproducibility, and service meet their standards. As actual manufacturers, we own the full lifecycle of a batch, from raw mineral to handed-off drum or bag, and remain responsible for the outcome.

    Each plant has its quirks, each batch poses its own personality, and teams spend equal time maintaining control and adapting to surprise. Somewhere between policy and practice, we build the hard-won expertise that makes reliable, repeatable Acamprosate Calcium supply possible. In a changing world, our confidence rests not on paperwork, but on decades of handled material, site-worn notebooks, and open lines of communication from the plant floor to the user’s tableting room. Real value lies not only in the powder but in everything it took to produce it to exacting standards.