99% Amphotericin B API Of GMP Factory
Amphotericin B is a critical antifungal agent used in life-saving treatments for severe fungal infections, including systemic candidiasis, aspergillosis, and cryptococcal meningitis.
OCTAGONCHEM is a trusted global supplier of high-purity Amphotericin B Active Pharmaceutical Ingredient (API). We specialize in providing cGMP-compliant APIs to pharmaceutical manufacturers, API importers, and compounding pharmacies worldwide.
Our Amphotericin B API is manufactured under stringent quality controls to ensure consistency, potency, and safety for critical antifungal therapeutics.
Whether you are developing injectable formulations, producing finished dosage forms, or compounding patient-specific medications, our reliable supply chain and extensive documentation support your regulatory and quality requirements.
Why Import Amphotericin B API From Us?
#1. GMP/DMF Available:
China NMPA has approved our Amphotericin B API manufacturing line, and our manufacturing facility has been issued a Good Manufacturing Practice (GMP) certificate.
#2. Low MOQ:
Our MOQ for liposomal injection-grade powder starts at 1 KG, but the topical type starts at 100 Grams
We offer customized packages tailored to your specific lab research needs.
#3. Faster Shipping:
If you are taking a standard package, we can ship it within 2 days and provide you with FedEx tracking information.
Amphotericin B API Applications and Specifications
Applications:
Amphotericin B API is a yellow-to-orange powder.
It is insoluble in water but readily soluble in lipids and is often made into liposomal injections.
Amphotericin binds to ergosterol to depolarize the membrane and alter cell membrane permeability.
This allows key intracellular components to leak out of cells, leading to bacterial cell death.
Technical Documents Download
Product Name: Amphotericin B APIs (两性霉素B)
Appearance: An orange-to-yellow powder
Cas Number: 1397-89-3
Molecular Formula: C47H73NO17
Molecular Weight: 924.1 g/mol
Chemical Name: (1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid
HS Code: 2941909099 (Other antibiotics-其他抗菌素)
Suitability to be shipped by air as common goods: suitable to be shipped by air.
Grade: Pharma-Grade (Oral/injection/liposomal)
Purity or Assay/Potency: 80%~99% (Different grades have different purities)
Standards: Current USP Standards
Certificates available: GMP/DMF
Documents Available: COA/MSDS
Supply Capability: 100KG per year
MOQ: 100G
Oral Amphotericin B API Bulk Price Ideas In 2025: 1800USD~11000USD~20000USD/1KG, depending on your desired grade. (Contact us directly through WhatsApp or email for more updated prices)
Lead Time: 5~7 days for quantities less than 10KG, 3~4 days for orders less than 1KG.
Stock Status: Over 20KG
Shipping Temperature: Room temperature for topical grade, 2~8 Degrees Celsius for injection grade.
Technical Data for Topical Grade:
Loss on drying: NMT5.0%
Residue on ignition: NMT3.0%
Limit of amphotericin A: NMT15%
Assay: NLT750ug/mg
Microbial limits: Total aerobic counts: NMT100cfu/g, Salmonella: Negative, Escherichia: Negative.
Residual solvents: Ethanol: NMT5000ppm, Acetone: NMT5000ppm
If you are looking for China’s leading Amphotericin B GMP Manufacturer, please leave us a message, and we will provide you with an offer for your reference. We continually aim to add value to all our customers.
Why Choose Us As Your Amphotericin B API Supplier?
- 15+ Years of Expertise: Decades of experience supplying APIs to 50+ countries, with a focus on antifungal and oncology activities.
- End-to-End Support: From pre-formulation guidance to post-purchase technical assistance, our R&D team is with you at every stage.
- Sustainable Sourcing: Ethical raw material procurement and eco-friendly packaging options (recyclable drums, biodegradable sachets).
- 24/7 Customer Access: Dedicated account managers for urgent inquiries, order tracking, and supply chain optimization.
FAQs About Our Amphotericin B API
1. What is the primary therapeutic use of your Amphotericin B API?
Our bulk Amphotericin B API is used as the active ingredient in antifungal medications. It is critically important for the treatment of severe, systemic fungal infections and leishmaniasis. These infections are often life-threatening and can affect immunocompromised patients, such as those undergoing chemotherapy, organ transplant recipients, or individuals with HIV/AIDS.
2. What forms of Amphotericin B API do you supply?
We primarily supply conventional Topical-grade Amphotericin B raw materials, the standard form used in many antifungal injections. Additionally, we offer high-purity grades suitable for developing advanced drug delivery systems, including liposomal Amphotericin B formulations (such as Ambisome® generics). Please get in touch with our technical sales team to discuss the grade that best suits your application.
3. Are you a manufacturer or a trader? Can you provide a DMF?
OCTAGONCHEM is a distributor of the Amphotericin B API. Yes, we maintain a fully updated and active Drug Master File (DMF) for our Amphotericin B API to support commercial order quantities. This document is submitted to regulatory agencies to support our customers’ drug application filings and streamline their approval process.
4. What quality certifications and standards do you comply with?
Our manufacturing facilities and processes are designed to meet global regulatory standards. We are compliant with current Good Manufacturing Practice (cGMP). Our Amphotericin B API consistently meets the specifications of major pharmacopeias, including:
USP (United States Pharmacopeia)
EP (European Pharmacopeia)
JP (Japanese Pharmacopeia)
Each batch is accompanied by a comprehensive Certificate of Analysis (COA) verifying its identity, purity, potency, and safety.
5. What documentation do you provide with each shipment?
With every order, you will receive a complete set of documents to ensure smooth customs clearance and quality assurance:
Certificate of Analysis (C of A): Batch-specific analytical results.
Material Safety Data Sheet (MSDS/SDS): For safe handling and transport.
Commercial Invoice & Packing List.
Certificate of Origin.
6. What is your minimum order quantity (MOQ) and lead time?
Our standard Minimum Order Quantity (MOQ) is 1 kilogram. However, we understand the needs of compounding pharmacies and R&D departments and can accommodate smaller quantities for evaluation. We recommend contacting us for specific and urgent requirements.
7. How should Amphotericin B API be stored, and what is its shelf life?
Amphotericin B is a light-sensitive and thermolabile compound. It must be stored in tight, light-resistant containers at a controlled temperature of 2°C to 8°C (refrigerated, do not freeze). Under these conditions, the typical shelf life is 24 months from the date of manufacture. The exact expiry date is stated on the certificate of analysis and the product label.
8. Do you offer custom synthesis or contract manufacturing for Amphotericin B?
Yes, we have the capability for custom synthesis and contract manufacturing. This includes developing specific particle sizes, purities, or salt forms to meet unique formulation needs. If you are creating a novel drug delivery system or require a proprietary-grade product, our R&D team is available to collaborate with you. Please reach out to discuss your project specifics.
9. I am a compounding pharmacy. Is your API suitable for sterile compounding?
Absolutely. Our high-purity, low-endotoxin-grade Amphotericin B API is an excellent choice for sterile compounding pharmacies preparing patient-specific antifungal formulations. We provide the necessary documentation to support your compounding activities. It is crucial to follow all USP <797> and <800> guidelines when handling sterile and hazardous drugs during compounding.
10. How does the stability and solubility of Amphotericin B impact formulation?
Amphotericin B is poorly soluble in water, which is why it is formulated with deoxycholate or in liposomal complexes for intravenous administration. Its instability to light, heat, and extreme pH requires careful handling during manufacturing. Our technical data sheet provides detailed information on solubility and stability profiles to support your formulation scientists’ process development.
11. What is the difference between Amphotericin A and Amphotericin B?
This is a key technical distinction. While both are polyene macrolide antibiotics produced by Streptomyces bacteria, Amphotericin B is therapeutically significant and vastly more potent against fungal pathogens. Amphotericin A has minimal antifungal activity. All our products are Amphotericin B, the only form used in human and veterinary medicine.
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