99% FDA-Approved Bacitracin API Of GMP/CEP Factory In China
Supply your formulations with confidence using our USP-grade Bacitracin Active Pharmaceutical Ingredient (API).
Engineered for topical, ophthalmic, and veterinary applications, our Bacitracin API delivers the consistent potency required by global manufacturers and compounding pharmacies.
We don’t just supply APIs – we deliver end‑to‑end service excellence.
Our Bacitracin API is manufactured under strict current Good Manufacturing Practice (cGMP) conditions, meeting USP, EP, and ChP pharmacopoeial standards. Whether you’re a pharmaceutical manufacturer developing topical or ophthalmic formulations, a compounding pharmacy preparing patient-specific preparations, or an API buyer seeking reliable supply, we deliver consistency, traceability, and regulatory confidence with every batch.
Why Choose Us As Your Bacitracin API Supplier?
#1. GMP/CEP/USFDA Approval for foreign MOH registration:
Our Bacitracin API factory has been manufacturing it for over 20 years. Many customers from the USA and Canada have audited our production facility.
#2. High quality:
Strictly meeting USP42 standards.
We also have injection-grade powder packed in a sterile container.
#3. Quality Guarantee:
OCTAGONCHEM is a bacitracin API supplier in China that offers a full refund or a free exchange of another batch for any quality issues that may arise after you receive it.
Bacitracin API Applications and Specifications
Trusted by Global Manufacturers for Consistent Purity, Reliability, and Compliance
Manufacturer Documents Download
Topical Antibiotic Preparations
Bacitracin is widely used in topical formulations to prevent and treat localized skin infections. First-aid antibiotic ointments containing Bacitracin (often in combination with neomycin and polymyxin B) are used to help prevent infection in minor cuts, burns, and scrapes. Its efficacy against common Gram-positive pathogens, including Staphylococci and Streptococci, makes it a trusted component of over-the-counter and prescription topical antibiotic products.
Ophthalmic Applications
Bacitracin is indicated for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin-susceptible organisms. It is formulated as a sterile ophthalmic ointment, often in combination with polymyxin B sulfate. Ophthalmic preparations containing Bacitracin are used for:
Superficial bacterial infections of the external eye and its adnexa
Corticosteroid-responsive ocular conditions with concurrent superficial bacterial infection or risk of infection
Injectable Formulations
Bacitracin for Injection, USP, is a sterile preparation for intramuscular administration. It is used for systemic antibiotic therapy in serious infections caused by susceptible organisms. A dose of 200–300 units/kg every 6 hours achieves serum levels of 0.2 to 2 mcg/mL in individuals with normal renal function. Bacitracin for Injection is typically administered only in hospital settings due to its nephrotoxicity profile.
Compounding Pharmacy Applications
For compounding pharmacies, our Bacitracin API provides the flexibility to formulate:
Topical ointments and creams — for wound care and skin infections
Ophthalmic ointments — for ocular infections
Custom combination products — with neomycin, polymyxin B, or corticosteroids
Specialized preparations — for patients with sensitivities to other antibiotics
Bacitracin for prescription compounding is the purified, dried form intended for extemporaneous compounding by practicing pharmacists. For prescription compounding use, the label should indicate that it is not sterile and that the potency cannot be assured for longer than 60 days after opening — a critical consideration for compounding pharmacists managing beyond-use dating.
Product Name: Bacitracin APIs (Bacitracina, 杆菌肽)
Appearance: A white to off-white powder
Cas Number: 1405-87-4
Molecular Formula: C66H102N17O16S
Molecular Weight: 1421.69 g/mol
Chemical Name: (4R)-4-[[(2S)-2-[[(4R)-2-[(1S,2S)-1-amino-2-methylbutyl]-4,5-dihydro-1,3-thiazole-4-carbonyl]amino]-4-methylpentanoyl]amino]-5-[[(2S,3S)-1-[[(3S,6R,9S,12R,15S,18R,21S)-3-(2-amino-2-oxoethyl)-18-(3-aminopropyl)-12-benzyl-15-[(2S)-butan-2-yl]-6-(carboxymethyl)-9-(1H-imidazol-5-ylmethyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptazacyclopentacos-21-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
HS Code: 2941909099 (Other antibiotics-其他抗菌素)
Suitability to be shipped by air as common goods: suitable. It is safe to ship by air as a common good.
Grade: Pharma-Grade (non-sterile/sterile)
Purity or Assay: 99%
Standards: Current USP Standards
Manufacturer Certificates available: GMP/WC/COPP
Manufacturer Documents Available: COA/MSDS/MOA
Supply Capability: 200KG per month
MOQ: 100G
Price Ideas In 2024: 1100USD/1KG (Contact us by WhatsApp for more updated prices)
Lead Time: 2~3 days for quantities less than 5KG, 1~2 days for orders less than 500 g.
Stock Status: Over 20KG
Shipping Temperature: Room temperature
Storage: 2~8 °C (Long time)
FAQs about Bacitracin API
Q1. Is your bacitracin API suitable for FDA-Approved Formulation manufacturing and pharmacy compounding in Europe and North America?
A1. Yes, it is.
Our bacitracin API is certified to Chinese GMP (NMPA), CoPP (US FDA), and CEP (EDQM/EMA).
These three certificates enable us to export bacitracin API to Europe and the USA as an active pharmaceutical ingredient for use in the production of human medicine and pharmacy compounding.
Q2. Do you have the same price for injection-grade bacitracin and topical-grade API?
A2. Currently yes.
Our sterile injection-grade bacitracin API can be used to produce injections. We supply both sterile and non-sterile raw materials. If you require the topical/non-sterile grade, we will charge the same price as for the sterile type.
Q3. Is your bacitracin API micronized? We need it in a fine particle form for an ointment.
A3. Yes, it is.
Our bacitracin raw material is a micronized powder with a particle size distribution (PSD) of 100% smaller than 100 microns. If you need other particle sizes, we can micronize them accordingly.
Q4. Will you add ice bags to the package to stabilize the injection-grade bacitracin API during transport?
A4. We may consider adding ice bags for orders during the summer when temperatures exceed 40 Degrees Celsius. However, for seasons with temperatures below room temperature, it is safe not to use ice bags.
Q5. What is your minimum order quantity (MOQ) for Bacitracin API?
A5. Our MOQ is flexible to your needs. Whether it is 100 grams or 500 grams, we will repackage accordingly. Please get in touch with us directly for more information.
Q6. What is your lead time for Bacitracin API?
A6. Our lead time depends on your order quantities and quality requirements, such as specific Particle Size Distribution (PSD).
If you order our regular bacitracin API, we can ship the goods within 3 to 5 business days for orders under 50 kg.
Q7. Do you provide registration documents for Bacitracin API?
A7. Yes, we do.
We will provide a Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and Method of Analysis (MOA) for any orders our customers place.
We don’t provide DMF for commercial orders under 10 KG.
Q8. How do you ensure the quality of Bacitracin API?
A8. We follow strict GMP guidelines and conduct rigorous quality control and assurance procedures to maintain our high-quality standards.
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