Azithromycin API Manufacturer in India — WHO-GMP Certified Supplier & Exporter

Aarise Pharmaceuticals is a leading Azithromycin API manufacturer in India, supplying USP/BP/EP grade Azithromycin (CAS: 83905-01-5) to pharmaceutical companies in 18+ countries. Our WHO-GMP certified facility in Haridwar, India produces Azithromycin API at 99%+ purity for global regulated markets.

Azithromycin API — Product Specifications

About Azithromycin API

Azithromycin is a broad-spectrum macrolide antibiotic API widely used in the formulation of tablets, capsules, oral suspensions, and IV preparations. It is indicated for respiratory tract infections, skin infections, sexually transmitted infections, and community-acquired pneumonia. Azithromycin is on the WHO List of Essential Medicines and is one of the most widely prescribed antibiotics globally.

Why Source Azithromycin API from Aarise Pharmaceuticals?

• WHO-GMP Certified — manufacturing under cGMP standards accepted by global regulators
• 99%+ Purity — USP/BP/EP grade with full analytical package (CoA, RS, residual solvents)
• Regulatory Documentation — DMF support, CEP guidance, and regulatory dossier assistance
• Competitive Pricing — direct manufacturer pricing, no middlemen
• Reliable Supply — consistent batch-to-batch quality with adequate stock for commercial orders
• Export Experience — shipping to USA, Germany, Brazil, Mexico, UAE, South Africa and 12+ more countries
• Fast Turnaround — 7-14 day lead time for commercial quantities

Azithromycin API Export Markets

We export Azithromycin API from India to pharmaceutical manufacturers across regulated and semi-regulated markets:

• Americas — USA (US FDA), Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), Argentina (ANMAT), Peru (DIGEMID)
• Europe — Germany (EMA/BfArM), Netherlands (IGJ), Poland (URPL), UK (MHRA), Turkey (TITCK)
• Asia-Pacific — South Korea (MFDS), Japan (PMDA), Australia (TGA), Philippines (FDA), Thailand (FDA Thailand)
• Middle East & Africa — UAE (MOH), South Africa (SAHPRA)

Quality & Analytical Testing

Every batch of Azithromycin API from Aarise Pharmaceuticals is tested against USP/BP/EP specifications:

• Identification (IR, HPLC)
• Assay (HPLC) — 99%+ purity
• Related Substances — individual and total impurities within USP limits
• Water content (Karl Fischer)
• Residual Solvents (ICH Q3C)
• Heavy Metals
• Microbial limits
• Particle size distribution

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Request Azithromycin API pricing: Send your quantity requirements, destination country, and preferred grade (USP/BP/EP) to our export team. We respond within 24 hours with a competitive FOB/CIF quote and CoA sample.