Bulk Pharmaceutical API Sources for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246654
NovoSeek		101526
Ambinter		KS-1181
Hangzhou APIChem Technology		AC-1275

Bulk API Sources for Avelox in Sodium Chloride 0.8% in Plastic Container

Last updated: February 21, 2026

What are the key API suppliers for moxifloxacin (the active ingredient in AVELOX)?

The active pharmaceutical ingredient (API) in AVELOX is moxifloxacin hydrochloride. Several companies manufacture and supply bulk moxifloxacin API, primarily located in Asia, Europe, and North America. Notable suppliers include:

• Shanghai Fosun Pharmaceutical (China): Produces pharmaceutical-grade moxifloxacin API with WHO-GMP certification.
• Suzhou R&D Pharmaceutical Chemistry (China): Supplies high-purity API to various markets.
• Novartis AG (Switzerland): Historically involved in API manufacturing, though now focusing on finished form.
• Hetero Labs (India): Offers API production with GMP compliance.
• Mingde Chemical (China): Provides bulk API for global markets.

Quality standards and certifications

Suppliers typically certify APIs to international standards, including:

• GMP (Good Manufacturing Practice)
• ISO certification
• Certificates of analysis (COA) are detailed for each batch, confirming purity (>99%), sterility, and absence of residual solvents.

Supply chain considerations

Geographical distribution: Most API sources are based in China and India, with some European producers maintaining smaller, high-quality supplies. Supply shortages have been reported due to regulatory shifts and manufacturing capacity constraints.

Pricing: API prices fluctuate based on purity grade, quantity, and regulatory compliance. Standard market prices for moxifloxacin API range roughly between $70 to $120 per kilogram (as of 2023), depending on specifications and supplier negotiations.

Regulatory implications

Manufacturers buy API compliant with pharmacopeias such as USP, EP, or IPL (Indian Pharmacopoeia). Suppliers with US FDA, EMA, or PMDA approvals offer confidence for markets with strict regulatory requirements.

Sourcing strategies

• Direct procurement: From certified manufacturers with proven compliance and supply security.
• Third-party distributors: Managed to ensure quality but may involve additional verification.
• Contract manufacturing organizations (CMOs): Many CMOs produce API under licensing agreements, often sourcing from primary API suppliers.

Summary table

Supplier	Location	Certification	MOQ (kg)	Price range ($/kg)	Regulatory Compliance
Shanghai Fosun Pharma	China	GMP, ISO	50	70-100	WHO-GMP, EMA, FDA
Suzhou R&D Pharma	China	GMP	10	80-110	ISO, CE
Hetero Labs	India	GMP, ISO	25	75-105	US FDA, EMA
Mingde Chemical	China	GMP	20	70-100	ISO
Novartis (historical)	Switzerland	GMP	N/A	Industry average	EMA, FDA

Conclusion

Most bulk API for moxifloxacin hydrochloride for AVELOX in saline solution is sourced from China and India. Quality is primarily verified through GMP certification, with prices varying based on volume and specifications. Supply chain stability depends on geopolitical factors and regulatory adherence.

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Key Takeaways

• Primary API suppliers are based in China and India, with certified GMP standards.
• API prices range from $70 to $120 per kilogram, influenced by purity and compliance.
• Supply chains are subject to geopolitical and regulatory shifts.
• Regulatory adherence, including WHO-GMP, EMA, or FDA, remains critical for entering global markets.
• Many manufacturers produce API for multiple clients, often under licensing or contract manufacturing agreements.

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FAQs

1. What regulations must API suppliers meet for international markets?
Suppliers must comply with GMP standards outlined by respective authorities (FDA, EMA, WHO). Certificates like COA and certification by recognized agencies are essential.

2. Can API quality vary between suppliers?
Yes, even with certifications, purity levels, residual solvents, and sterility can vary. Buyers should verify COA for each batch.

3. Are there options for organic or specialty formulations of moxifloxacin API?
Standard APIs are synthetic; specialty or organic labels are uncommon and generally not relevant for antibiotics like moxifloxacin.

4. How does supplier location influence API availability?
Proximity to manufacturing hubs impacts lead times and responsiveness; Chinese and Indian suppliers dominate due to capacity and cost advantages.

5. What are the risks associated with API sourcing from emerging markets?
Risks include regulatory inconsistencies, quality variation, intellectual property concerns, and geopolitical factors impacting supply continuity.

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References

1. US Food and Drug Administration. (2022). Guidance for Industry: API Quality and Manufacturing.
2. European Medicines Agency. (2021). Validation of manufacturing processes.
3. World Health Organization. (2020). WHO Good Manufacturing Practices.
4. MarketWatch. (2023). API cost trends and supply chain analysis.
5. PharmaCompass. (2023). API vendor directory and certification status.