Azithromycin API bulk supplier for pharma manufacturers

Azithromycin API Suppliers & Bulk Manufacturers

Available Forms: Crystalline powder

Available Strengths: API Purity: 98% (on dry basis) / Standard content expressed as Azithromycin equivalent

Reference Brands: Zithromax (US/EU)

Category: Active Pharmaceutical Ingredient

Azithromycin used to treat or prevent certain bacterial infections: Acute bacterial exacerbations of chronic bronchitis in adults; acute bacterial sinusitis in adults; uncomplicated skin and skin structure infections in adults; urethritis and cervicitis in adults; genital ulcer disease in men; acute otitis media in pediatric patients; community-acquired pneumonia in adults and pediatric patients; pharyngitis/tonsillitis in adults and pediatric patients.

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Manufacture or export Azithromycin API? List it or send an offer →

Product Description:

Azithromycin is a macrolide antibiotic used in tablets, capsules, oral suspensions, intravenous infusions and eye drops. It works by blocking bacterial protein synthesis and is active against many respiratory, skin and sexually transmitted pathogens, including atypical organisms such as Chlamydia and Mycoplasma. The reference brand is Zithromax.

Azithromycin API manufacturing in India

Azithromycin API is made by many Indian bulk-drug manufacturers, and Indian companies hold a number of US Drug Master Files and European Certificates of Suitability (CEPs) for it. The API is semi-synthetic: it is made in several chemical steps from erythromycin A, which is itself produced by fermentation. Because erythromycin supply drives cost and availability, it is worth asking a manufacturer where its erythromycin comes from.

Most commercial azithromycin API is azithromycin dihydrate. Azithromycin monohydrate is also made and is more hygroscopic. The two forms are not interchangeable in a registered product, so confirm which one your dossier specifies before you ask for quotes.

What to ask an azithromycin API supplier

Grade: USP, Ph. Eur., BP or IP, matching your registration.
Regulatory documents: a US DMF, a European CEP or the dossier format your regulator accepts, plus the site's GMP certificate.
A recent Certificate of Analysis covering assay, related substances, water content and residual solvents.
A nitrosamine risk assessment, which most regulators now expect for every API.
Particle size and bulk density, which matter for suspensions and direct-compression tablets.

Our explainers on the Drug Master File, the Certificate of Analysis and how APIs are bought cover these points in more detail.

Finished azithromycin products

If you need the finished product rather than the API, we also list azithromycin tablets (250, 500 and 600 mg), azithromycin intravenous infusion, azithromycin oral suspension and azithromycin eye drops, which we source from GMP-certified manufacturers for export or third-party manufacturing.

Tell us the grade, quantity and destination market and send us an RFQ. We match your enquiry with manufacturers whose documents fit that market and confirm price, lead time and document status before you commit.

Buying an API? See what to check in an API supplier: the DMF or CEP, written confirmation for the EU, GMP evidence and the Certificate of Analysis.

Azithromycin API — third party manufacturing & bulk supply

Azithromycin API is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Azithromycin API is supplied as Crystalline powder — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Azithromycin API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.

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Frequently Asked Questions

Azithromycin API is made by many Indian bulk-drug manufacturers, several of which hold US DMFs and European CEPs. We match each enquiry with manufacturers whose grade, approvals and documents fit your destination market.

It is semi-synthetic. Erythromycin A, produced by fermentation, is converted to azithromycin in a series of chemical steps and then crystallised, usually as the dihydrate.

They are the same active substance with different amounts of bound water. The dihydrate is the more common commercial form; the monohydrate is more hygroscopic. Use the form named in your registration dossier.

A Certificate of Analysis to the relevant pharmacopoeia, a DMF or CEP for your market, the manufacturer's GMP certificate and a nitrosamine risk assessment. From a new supplier, ask for a sample and stability data as well.