Azithromycin API Manufacturer for Mexico | WHO GMP Certified India

Azithromycin API Manufacturer for Mexico — WHO GMP Certified India Supplier | Aarise Pharmaceuticals

Aarise Pharmaceuticals is a WHO GMP certified Azithromycin API manufacturer in India supplying pharmaceutical importers, formulation companies, and distributors in Mexico with USP/BP grade Azithromycin Dihydrate at 98.0%+ HPLC purity. We offer competitive CIF pricing to Mexico City (CDMX) and Guadalajara, complete COFEPRIS-ready documentation, and reliable supply for Mexican pharma companies producing antibiotic tablets, oral suspensions, and injectable Azithromycin formulations. As one of India’s established Azithromycin API suppliers for Mexico, we provide everything Mexico-based importers need for compliant, efficient procurement.

Mexico’s Pharmaceutical Market and Azithromycin Demand

Mexico is the largest pharmaceutical market in Latin America, valued at over USD 16 billion. With a strong domestic formulation industry in Mexico City, Guadalajara, and Monterrey, Mexico is a major producer of generic antibiotics for domestic consumption and Latin American export. Azithromycin is one of the most widely prescribed antibiotics in Mexico, used in community-acquired pneumonia, respiratory tract infections, sexually transmitted infections, and paediatric indications. Mexican pharmaceutical companies import a significant share of Azithromycin API from Indian and Chinese manufacturers, with Indian suppliers increasingly preferred due to WHO GMP quality and COFEPRIS regulatory acceptance.

Azithromycin API Import Requirements for Mexico (COFEPRIS)

Mexico’s pharmaceutical regulatory authority COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) sets strict requirements for pharmaceutical API imports. Key requirements for Azithromycin API imports from India:

• COFEPRIS Import Licence: Mexican pharmaceutical companies require an active COFEPRIS import licence (Licencia Sanitaria) covering pharmaceutical ingredient imports.
• Sanitary Registration (Registro Sanitario): Finished pharmaceutical products containing Azithromycin API must hold COFEPRIS Registro Sanitario. API imports are governed by the approved Registro Sanitario’s source documentation.
• WHO GMP Certification: COFEPRIS requires WHO GMP or equivalent GMP certification for foreign API manufacturers. Our WHO GMP certificate is accepted by COFEPRIS for Indian API suppliers.
• Certificate of Analysis (COA): Batch-specific COA from manufacturer QA required for every shipment. Must meet pharmacopoeial specifications.
• Certificate of Pharmaceutical Product (CPP): CPP from India’s CDSCO may be required for COFEPRIS import authorisation and Registro Sanitario applications. We provide CPP on request.
• Certificate of Origin: India-origin certificate for Mexico customs clearance. Mexico-India trade (GSTP framework) may offer tariff benefits for pharmaceutical imports.
• MSDS: Safety data sheet required for Mexico customs and storage compliance.

Our regulatory affairs team is familiar with COFEPRIS requirements for Indian API manufacturers and can support your Mexico import team through the supplier documentation and authorisation process.

Azithromycin API Specifications

• Substance: Azithromycin Dihydrate (macrolide antibiotic)
• Chemical Name: (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate
• CAS Number: 117772-70-0 (dihydrate); 83905-01-5 (anhydrous)
• Molecular Formula: C₃₈H₇₂N₂O₁₂ · 2H₂O
• Molecular Weight: 785.0 g/mol (dihydrate)
• Grade: USP / BP / EP
• Purity (HPLC): 98.0%+ (NLT 96.0% anhydrous per USP)
• Appearance: White or almost white crystalline powder
• Water Content (Karl Fischer): 4.0–5.0% (as dihydrate)
• pH (1% solution): 9.0–11.0
• Related Substances: Per USP/BP limits — individual impurities NMT 0.5%
• Residual Solvents: Meets ICH Q3C Class 2/3 limits
• Microbial Limits: Meets USP/BP pharmacopoeial limits
• Heavy Metals: Meets pharmacopoeial limits
• Storage: Below 30°C, in a dry place, protected from light
• Shelf Life: 24 months from date of manufacture

Available form: Azithromycin Dihydrate (standard oral and injectable API). Azithromycin Anhydrous available on request. EP/USP grade for both forms.

Formulation applications in Mexico: Oral tablets (250mg, 500mg), oral suspensions/dry syrups (100mg/5mL, 200mg/5mL), oral sachets (1g single-dose), film-coated tablets, and IV injectable formulations (Azithromycin for injection, 500mg).

Pricing and MOQ for Mexico Buyers

• Sample Orders: 100g–500g for COFEPRIS analytical testing and quality evaluation. Air freight to Mexico City (MEX/AICM) in 3–5 days.
• Standard Commercial Orders: 5kg minimum. EXW or CIF Mexico City/Guadalajara pricing available.
• Bulk Orders: 25kg and above with volume pricing. Sea freight to Manzanillo Port (Pacific) or Veracruz Port (Gulf) — 21–28 days from India.
• Incoterms: EXW (Haridwar), FOB (JNPT Mumbai), CIF (Mexico City airport / Manzanillo or Veracruz seaport) — as preferred by Mexico buyer.
• Payment Terms: TT advance (USD) for first orders. LC accepted for bulk orders >USD 5,000. 30-day credit terms for established Mexico accounts.
• Annual Contracts: Monthly supply agreements with price-locked annual contracts for Mexico companies with regular Azithromycin API requirements.

Shipping and Logistics to Mexico

• Air Freight (Samples and Urgent Orders): 3–5 days to Mexico City (AICM/Benito Juárez International Airport, MEX) via connecting flights through Amsterdam, Atlanta, or Miami. Suitable for quantities up to 50kg.
• Sea Freight (Commercial Bulk): 21–28 days to Manzanillo Port (Pacific coast — main container port for western Mexico) or 25–32 days to Veracruz Port (Gulf coast — for central/eastern Mexico). Shipped from JNPT Mumbai in FCL or LCL containers.
• Express Courier (Samples): FedEx or DHL Express — 3–5 days to Mexico City or Guadalajara for samples up to 2kg.
• Cold Chain: Azithromycin API is stable at ambient temperature (below 30°C). Standard pharmaceutical packaging is sufficient. No cold chain required.
• Customs Clearance: We provide all required documents for SAT/COFEPRIS customs clearance in Mexico. We work with Mexico-based customs brokers on request for seamless clearance.

Documentation for COFEPRIS Compliance

• Certificate of Analysis (COA) — batch-specific, HPLC purity, QA-signed, English
• MSDS (Material Safety Data Sheet) — GHS-compliant, English and Spanish versions available
• Certificate of Origin — India-origin, Chamber of Commerce issued
• WHO GMP Certificate — valid facility certificate copy
• Certificate of Pharmaceutical Product (CPP) — from CDSCO, on request
• Free Sale Certificate — from CDSCO on request
• COFEPRIS Supplier Documentation Support — GMP recognition and audit support
• Pharmacopoeial Compliance Statement — USP/BP/EP
• Commercial Invoice and Packing List — per shipment
• Stability Data — available on request for dossier support

Who We Supply — Azithromycin API in Mexico

• Licensed Mexican Pharmaceutical Manufacturers: Companies producing Azithromycin tablets, suspensions, sachets, and injectables with COFEPRIS Registro Sanitario for domestic and export markets
• Generic Drug Companies: Mexico-based generic manufacturers (including Monterrey, Guadalajara, and CDMX industrial clusters) requiring USP/BP API for COFEPRIS-registered generics
• Pharmaceutical Importers and Distributors: COFEPRIS-licensed API importers supplying to smaller Mexican formulation companies
• Paediatric Pharma Companies: Companies specialising in paediatric Azithromycin dry syrups and suspensions — high-demand segment in Mexico’s antibiotic market
• Latin American Export Manufacturers: Mexico-based companies exporting finished Azithromycin formulations to Central America and the Caribbean

Frequently Asked Questions — Azithromycin API for Mexico

Is your WHO GMP certificate accepted by COFEPRIS?

Yes. COFEPRIS accepts WHO GMP certification from Indian API manufacturers as part of their foreign supplier qualification process. Our facility holds a valid WHO GMP certificate from India’s regulatory authority. We provide a certified copy of the WHO GMP certificate as part of the documentation package for your COFEPRIS supplier qualification and import licence application.

What is the MOQ for Azithromycin API for Mexico importers?

Minimum sample order is 100g–500g for COFEPRIS quality evaluation and formulation trials. Standard commercial minimum is 5kg. For sea freight via Manzanillo or Veracruz, we recommend minimum 25kg to optimise per-unit freight costs. Annual contract buyers can arrange monthly deliveries from 5kg upward with committed pricing.

How long does shipment from India to Mexico take?

Air freight to Mexico City (MEX): 3–5 days for quantities up to 50kg. Sea freight to Manzanillo: 21–28 days from JNPT Mumbai. Express courier for samples: 3–5 days. Add 3–5 days for India export clearance and 5–10 days for COFEPRIS/SAT Mexico import clearance to estimate total delivery timeline.

Can you provide a Certificate of Pharmaceutical Product (CPP) for COFEPRIS?

Yes. We can obtain a CPP from India’s CDSCO for Azithromycin API. The CPP documents that the product is manufactured and sold in India in accordance with Indian pharmaceutical regulations. COFEPRIS may require CPP for Registro Sanitario applications and import authorisation. The CPP process takes approximately 30–45 days. Contact our regulatory team with your COFEPRIS filing details.

Do you supply Azithromycin in both Dihydrate and Anhydrous forms?

Yes. We supply Azithromycin Dihydrate (standard form, most commonly used for oral formulations) and Azithromycin Anhydrous (for specific formulation requirements) in USP/BP/EP grade. We also supply Azithromycin for Injection (API grade suitable for IV injectable formulations). Contact us for specifications and pricing for each form.

What is the transit time via sea freight from India to Manzanillo, Mexico?

Sea freight from JNPT (Nhava Sheva, Mumbai) to Manzanillo Port typically takes 21–28 days transit time, depending on the shipping line and routing. Direct services are available via MSC, CMA CGM, and Evergreen via the transshipment hubs of Colombo or Singapore. We provide the estimated transit time in the shipping documentation and coordinate with Mexico customs brokers for smooth clearance.

Can you supply Azithromycin API for paediatric dry syrup formulations?

Yes. Our Azithromycin Dihydrate API (USP/BP grade) is suitable for paediatric dry syrup and suspension formulations (100mg/5mL and 200mg/5mL), a major market segment in Mexico. We can supply particle size-controlled grades suitable for smooth suspension formation on reconstitution. Contact us to discuss particle size specification requirements for your paediatric formulation.

Why Mexico Pharma Companies Choose Aarise for Azithromycin API

• WHO GMP Certified: COFEPRIS-accepted manufacturing standards — GMP recognition process supported
• USP/BP/EP Compliance: Full pharmacopoeial testing on every batch with reference standards
• 98%+ HPLC Purity: Consistent quality for tablet, suspension, and injectable formulations
• Competitive CIF Pricing: Indian manufacturer cost advantage — competitive vs. European and US suppliers
• Complete COFEPRIS Documentation: COA, MSDS, CPP, WHO GMP, Certificate of Origin, Free Sale Certificate
• Latin America Experience: Supplying antibiotics APIs to Brazil, Colombia, Peru, Chile, Mexico, and Argentina
• Paediatric Grade Available: Particle size-controlled grades for dry syrup formulations
• Fast Sample Dispatch: Air freight samples to Mexico City in 3–5 days
• English and Spanish Support: Export team with Spanish documentation support for COFEPRIS submissions