Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of fluconazole capsule in China. Welcome to wholesale bulk high quality fluconazole capsule for sale here from our factory. Good service and reasonable price are available.
Fluconazole capsule is a widely used systemic antifungal drug and a representative of the third-generation triazole compounds - a core product in Bloomtechz's antifungal portfolio. Its mechanism of action involves highly selective inhibition of 14α-lanosterol demethylase (encoded by the ERG11 gene) in the fungal cytochrome P450 enzyme family, blocking the biosynthesis of ergosterol, a key component of the fungal cell membrane. Manufactured by Bloomtechz under strict quality control, every batch of our fluconazole capsules delivers consistent purity and performance for global partners.
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Additional information of chemical compound:
Our product form
Fluconazole COA
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| Certificate of Analysis | ||
| Compound name | Fluconazole | |
| Grade | Pharmaceutical grade | |
| CAS No. | 86386-73-4 | |
| Quantity | 19g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090057 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.21% |
| Loss on drying | ≤1.0% | 0.58% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.86% |
| Single impurity | <0.8% | 0.53% |
| Total microbial count | ≤750cfu/g | 427 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 535ppm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
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Product Introduction
The capsules are filled with white or off-white crystalline powder in hard or soft shell forms, and a micronization process is applied to ensure uniform particle size (D90 < 50 μm), significantly improving the drug dissolution rate. The trifluoromethyl (–CF₃) group in its chemical structure enhances molecular lipophilicity, while the hydroxyl (–OH) group promotes gastrointestinal penetration through hydrogen bonding. Although fluconazole itself is slightly soluble in water (solubility approximately 0.5–1 mg/mL), excipient optimization - such as lactose and cross-linked carboxymethyl cellulose sodium as disintegrants - allows the capsule to disintegrate rapidly in gastric acid (disintegration time < 15 minutes), releasing the drug particles.
After oral administration, fluconazole is rapidly and completely absorbed in the gastrointestinal tract, with a bioavailability of over 90%. Food has no significant effect on absorption, so patients can take it with or without meals, greatly improving medication convenience. Every step of this formulation, from micronization to encapsulation, is carried out at Bloomtechz's facility under controlled pharmaceutical conditions to ensure batch-to-batch consistency.In terms of formulation technology, Bloomtechz's fluconazole capsules adopt moisture-proof coating technology, effectively protecting the drug from degradation in humid and hot environments (accelerated stability testing at 40 °C / 75% RH for 6 months shows a content decrease of less than 2%),
ensuring long-term product stability. The specifications cover multiple strengths - 50 mg, 100 mg, 150 mg and 200 mg - flexibly meeting the needs of different infection types (e.g., 50–150 mg/day for superficial fungal infections and 200–400 mg/day for deep fungal infections) and special populations (e.g., 3–12 mg/kg/day for children). Clinical studies show that fluconazole capsules are as effective as intravenous preparations in treating oral and pharyngeal candidiasis, with a lower incidence of adverse reactions (mainly mild gastrointestinal discomfort and headache), making them the preferred dosage form for outpatient and long-term treatment.
Endemic fungal diseases are infections caused by fungi present in a specific geographic area, which reproduce in specific environments such as soil, vegetation, or animal hosts. Humans become infected through exposure to contaminated environments or inhalation of fungal spores. Fluconazole as a broad-spectrum and potent triazole antifungal drug, has become an important choice for the treatment and prevention of endemic fungal diseases due to its unique pharmacokinetic properties (such as high oral absorption rate, strong blood-brain barrier penetration, and wide tissue distribution) and low toxicity. Below, from the perspectives of treatment and prevention, combined with specific types of diseases, we will elaborate on their uses in detail.
Therapeutic use
1. Coccidiomycosis
Sphingosporosis is caused by Colletotrichum crus or Aspergillus nidulans, and is mainly prevalent in arid and semi-arid regions of the southwestern United States, Mexico, and Central and South America. Patients can be infected by inhaling spores from the air, and the lesions can affect the lungs, skin, bones, and central nervous system.
(1) Mild to moderate pulmonary coccidiosis
It is one of the preferred therapeutic drugs for mild to moderate pulmonary coccidiosis. It inhibits fungal growth by suppressing the synthesis of ergosterol on the cell membrane, disrupting membrane integrity.
The recommended dosage is 400-800 mg orally per day, and the course of treatment is usually 3-6 months.For patients with normal immune function, this course of treatment can effectively clear lung lesions; For those with impaired immune function (such as AIDS patients and organ transplant recipients), the course of treatment should be extended to 12 months or longer to prevent recurrence.
(2) Pneumocystis jirovecii
Skin lesions: Fluconal can treat cutaneous coccidiomycosis by inhibiting fungal proliferation in skin tissue, alleviating symptoms such as erythema, nodules, or ulcers. The dosage is the same as that of Pneumocystis aeruginosa, and the treatment course needs to be adjusted according to the severity and healing of the skin lesions.
Skeletal infection: For osteococcosis, fluconal can penetrate bone tissue to achieve effective therapeutic concentrations. Usually, combined surgical debridement or fixation surgery is required, with a daily dose of 400-800 mg and a course of treatment of 6-12 months.
(3) Pneumocystis aeruginosa meningitis
Fluconazole capsule is the preferred medication for maintenance treatment of Pneumocystis aeruginosa meningitis. Due to the long-term maintenance of treatment after induction therapy with amphotericin B to prevent recurrence, fluconal is an ideal choice as it can penetrate the blood-brain barrier well (cerebrospinal fluid concentration reaches 60% -80% of blood drug concentration).
The recommended dosage is 400-800 mg orally per day, and the course of treatment is usually 12-24 months, adjusted according to cerebrospinal fluid examination and imaging results.
2. Budding bacterial disease
Botrytis is caused by dermatitis caused by bacteria and is mainly prevalent in eastern North America, some parts of Africa, and India. Human infection through inhalation of spores can affect the lungs, skin, bones, and central nervous system.
(1) Mild to moderate pulmonary blastomycosis
Fluconal is an alternative treatment for mild to moderate pulmonary aspergillosis (itraconazole is preferred). It exerts antibacterial effects by inhibiting fungal cell membrane synthesis.
The recommended dosage is 400-800 mg orally per day for a course of 6-12 months. During the treatment period, regular follow-up chest X-rays or CT scans are required to evaluate the absorption of lung lesions.
(2) Blastomycosis cutis
Fluconal can treat cutaneous blastomycosis by inhibiting fungal proliferation in skin tissue, alleviating ulcers, nodules, or wart lesions. The dosage is the same as that of pulmonary aspergillosis, and the course of treatment needs to be adjusted according to the severity and healing of the skin lesions, usually ranging from 6 to 12 months.
(3) Severe budding bacterial disease
Disseminated blastomycosis: For disseminated blastomycosis involving multiple organs, fluconal needs to be used in combination with amphotericin B. Amphotericin B is used for induction therapy (rapid control of the condition), followed by sequential use of fluconal for long-term maintenance therapy (prevention of recurrence). Combination therapy can improve efficacy and reduce drug resistance.
Central nervous system blastomycosis: Fluconal is the preferred medication for maintenance treatment of central nervous system blastomycosis. After induction therapy with amphotericin B,
the recommended dosage is 400-800 mg orally per day for a course of 12-24 months, adjusted according to cerebrospinal fluid examination and imaging results.
3. Organic cytoplasmic bacterial disease
Histoplasmosis is caused by Clostridium perfringens and is mainly prevalent in parts of North America, South America, Africa, and Asia. Human beings can be infected by inhaling spores, and the lesions can affect multiple organs such as lungs, lymph nodes, liver, and spleen.
(1) Acute pulmonary histoplasmosis
Fluconal is an alternative treatment for mild to moderate acute pulmonary interstitial bacterial disease (itraconazole is preferred).
The recommended dosage is 400-800 mg orally per day for a course of 6-12 weeks. During the treatment period, it is necessary to monitor the improvement of symptoms such as fever, cough, and chest pain.
(2) Chronic pulmonary histoplasmosis
Simple chronic pulmonary tissue cytoplasmic bacterial disease: Fluconal can be used to treat uncomplicated chronic pulmonary tissue cytoplasmic bacterial disease, with a dose of 400-800 mg orally per day for a course of 12-18 months. Regular follow-up chest X-rays or CT scans are required during treatment to assess the progression of pulmonary fibrosis or cavities.
Complex chronic pulmonary histiocytosis: Fluconal should be used in combination with amphotericin B for patients with concomitant pulmonary fibrosis, pulmonary arterial hypertension, or respiratory failure. Amphotericin B is used for induction therapy, followed by sequential use of fluconal for long-term maintenance therapy.
(3) Histoplasmosis
Patients with normal immune function: Fluconal is an alternative treatment for mild to moderate disseminated histiocytosis (itraconazole is preferred). The recommended dosage is 400-800 mg orally per day for a course of 12-18 months.During the treatment period, it is necessary to monitor liver and kidney function and blood routine,
and adjust the dosage in a timely manner.
Patients with impaired immune function: For patients with AIDS, organ transplantation or long-term use of immunosuppressants, fluconal should be used in combination with amphotericin B. Amphotericin B is used for induction therapy, followed by sequential use of fluconal for long-term maintenance therapy (which may require lifelong medication).
Pneumocystis aeruginosa disease
Paracoccidiosis is caused by Brazilian paracoccidiomycosis and is mainly prevalent in tropical and subtropical regions of South America. Human infection through inhalation of spores can affect the lungs, skin, mucous membranes, and lymph nodes.Mild to moderate Pneumocystis aeruginosa infection
Fluconal is an alternative treatment for mild to moderate Pneumocystis aeruginosa disease (itraconazole is preferred). The recommended dosage is 400-800 mg orally per day for a course of 6-12 months. During the treatment period, it is necessary to monitor the improvement of symptoms such as fever, cough, and skin ulcers.
Severe Pneumocystis aeruginosa infection
Disseminated paracoccidiosis: For disseminated paracoccidiosis involving multiple organs, Fluconazole capsule needs to be used in combination with amphotericin B. Amphotericin B is used for induction therapy, followed by sequential use of fluconal for long-term maintenance therapy.
Fluconal is the preferred medication for maintenance treatment of central nervous system paracoccidiosis. After induction therapy with amphotericin B, the recommended dosage is 400-800 mg orally per day for a course of 12-24 months, adjusted according to cerebrospinal fluid examination and imaging results.
Main Raw Materials and Excipients
The core raw material is fluconazole with a purity complying with pharmacopoeial standards to ensure stable pharmaceutical efficacy. Pharmaceutical excipients include diluents (dextrin, microcrystalline cellulose, etc.), binders (povidone alcoholic solution, etc.) and sustained-release materials (ethyl cellulose, etc.). The selection of excipients shall meet pharmaceutical specifications with no harmful impurities, and the excipients must ensure the drug release performance and stability, meeting the requirements for capsule preparations.
Core Preparation Process
A large-scale preparation process with a concise and controllable flow is adopted: first, prepare blank pill cores, mix the diluents for granulation and drying for subsequent use; then mix fluconazole with stearic acid and sieve the mixture, spray the pill cores with the binder to moisten them, apply powder and dry to obtain plain pellets; subsequently, coat the pellets with sustained-release materials and dry to produce fluconazole pellets; finally, fill the pellets into enteric-soluble empty capsules and precisely control the filling amount to obtain the finished products. Key parameters such as temperature and humidity are strictly controlled throughout the process, making it suitable for industrial production.
Quality Control Standards
Strictly in accordance with pharmacopoeial specifications, the core control indicators are as follows: the content shall be 90.0%～110.0% of the labeled amount; the total content of related substances shall not exceed 1.0%; the dissolution rate shall reach more than 80% of the labeled amount within 45 minutes. Identification and content determination are carried out via thin-layer chromatography (TLC), high performance liquid chromatography (HPLC) and other methods to ensure the uniform quality and reliable pharmaceutical efficacy of the finished products.
Specifications and Storage Requirements
The common specifications are 50mg, 100mg and 150mg, which can meet the medication needs for different diseases. The finished products shall be hermetically packaged and stored in a dry place, protected from moisture and light to prevent drug degradation and inactivation and ensure quality stability during storage. The shelf life is usually 24 months, and all requirements under the capsule preparation monograph shall be complied with throughout the storage period.
References
[1]Fluconazole. (2024). In StatPearls. StatPearls Publishing.
[2]DIFLUCAN (fluconazole tablets, fluconazole injection, fluconazole for oral suspension) [Prescribing information]. (2010). U.S. Food and Drug Administration.
[3]Pappas, P. G., Kauffman, C. A., Andes, D. R., Clancy, C. J., Marr, K. A., Ostrosky-Zeichner, L., Reboli, A. C., Schuster, M. G., Vazquez, J. A., Walsh, T. J., Zaoutis, T. E., & Sobel, J. D. (2016). Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clinical Infectious Diseases, 62(4), e1–e50.
[4]Centers for Disease Control and Prevention. (2024, September 16). Prevent fungal diseases in the workplace. National Institute for Occupational Safety and Health.
[5]International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). Stability testing of new drug substances and products Q1A(R2).
Frequently Asked Questions
1. What is the minimum order quantity (MOQ)?
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Our MOQ is flexible and tailored to the order type. For first-time cooperation we offer small trial orders so you can verify Bloomtechz quality before scaling up, and volume pricing improves as your order size grows. Send us your target quantity and we will come back with the best available terms.
2. Can I get a sample before placing an order?
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Yes. Bloomtechz provides samples of our standard strengths (50 mg, 100 mg, 150 mg, 200 mg) free of charge, with only shipping costs on your side. Every sample is shipped with its Certificate of Analysis so you can confirm purity and quality before you buy.
3. Do you support OEM/ODM and private-label production?
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We do. As a contract manufacturer, Bloomtechz supports custom strengths, private-label packaging (blister, bottle, carton), custom branding and multilingual labels, with formulation and process support from our R&D team. Your design and IP are protected by NDA. Share your requirements and our engineers will confirm feasibility and give you a development timeline.
4. What quality documents do you provide?
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Every batch produced by Bloomtechz is shipped with a Certificate of Analysis (COA), and we can provide stability data, certificates, and complete export documentation on request. Third-party inspection (SGS, BV, etc.) is welcome before shipment, and customer audits are always open.
5. What is your lead time and how do you ship?
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Lead times are confirmed per order - we dispatch stock items quickly, and Bloomtechz's OEM/ODM production follows a schedule agreed with you upfront. We ship worldwide by sea, air or express under FOB, CIF or DDP terms with full export documentation. Contact us and we will confirm the fastest available schedule.
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