Bulk Pharmaceutical API Sources for MOXEZA

Bulk Pharmaceutical API Sources for MOXEZA

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-1275
Molport		MolPort-005-934-227
Oakwood Products		079434
BioChemPartner		BCP0726000173
BioChemPartner		BCP9000963
AKos Consulting & Solutions		AKOS015920132
Amadis Chemical		207264

Bulk Active Pharmaceutical Ingredient (API) Sources for MOXEZA

Last updated: July 28, 2025

Introduction

Moxeza, a topical ophthalmic solution containing moxifloxacin hydrochloride, is employed for treating bacterial conjunctivitis. The efficacy of MOXEZA hinges critically on the quality, purity, and supply stability of its active pharmaceutical ingredient (API), moxifloxacin hydrochloride. The global pharmaceutical industry relies on a network of API manufacturers and suppliers, each scrutinized for quality standards compliant with international regulations such as the FDA, EMA, and DMFs.

This report dissects key global suppliers of moxifloxacin API, evaluates their capabilities, and identifies factors influencing supplier choice for pharmaceutical companies developing or manufacturing MOXEZA.

Overview of Moxifloxacin API

Moxifloxacin is a fourth-generation fluoroquinolone antibacterial agent. Its chemical structure ([C_21H_24F_3N_3O_4]) imparts broad-spectrum antibacterial activity, notably against Gram-positive and Gram-negative bacteria responsible for ocular infections. High-purity API is essential in ophthalmic formulations to avoid ocular irritation and ensure therapeutic efficacy.

The chemical and pharmacological complexity of moxifloxacin necessitates manufacturers with advanced synthetic capabilities, rigorous quality control, and compliant documentation to meet pharmaceutical standards.

Key Geographies and API Manufacturers

1. China: Dominant API Manufacturing Hub

China hosts a significant share of moxifloxacin API production, with several manufacturers holding extensive capacity.

• Hefei Zizhuo Pharmaceutical Co., Ltd.
  Offers high-quality moxifloxacin API with compliance to USP, EP, and other pharmacopeia standards. The company operates under GMP conditions and supplies globally.

• Jiangsu Hengtian Pharmaceutical Co., Ltd.
  Provides bulk moxifloxacin hydrochloride, emphasizing consistent quality, competitive pricing, and reliable logistics channels.

• Chengdu Tiantaishan Pharmaceutical Co., Ltd.
  Specializes in small-molecule APIs, including moxifloxacin, with a focus on stringent quality control aligned with international standards.

2. India: Growing API Supplier Base

India’s API industry features several companies with proven capabilities in fluoroquinolones.

• Aurobindo Pharma Ltd.
  Known for integrated manufacturing, Aurobindo supplies APIs with robust quality assurance protocols, adhering to WHO-GMP standards.

• Lupin Limited
  Manufactures moxifloxacin API conforming to global regulatory standards. Their expertise lies in complex synthetic routes with high purity levels.

• Glenmark Pharmaceuticals
  Offers bulk APIs with a focus on innovation and compliance, backed by extensive R&D.

3. Europe: High-Quality, Regulated API Manufacturers

European manufacturers are often preferred for high-end applications requiring stringent quality controls.

• Lek Pharmaceuticals (Novartis Group)
  Historically involved in fluoroquinolone production, though supply specifics are confidential.

• Thermo Fisher Scientific
  While primarily a reagent supplier, they occasionally provide APIs or intermediates conforming to strict quality Regulations (e.g., GMP, ISO).

4. United States: Limited Moxifloxacin API Production

The U.S. market’s regulatory environment restricts large-scale API manufacturing domestically for fluoroquinolones but offers high-quality API options through partnerships and contract manufacturing organizations (CMOs).

• Substrate-controlled contract manufacturers with GMP compliance, such as APS Pharma and Cambrex, may cater to the U.S. market with imported APIs.

Supplier Selection Criteria

When sourcing moxifloxacin API for MOXEZA, key considerations include:

• Regulatory Compliance: GMP certification, FDA/EMA approval, and robust validated processes.

• Quality and Purity: APIs should meet or exceed pharmacopeial standards (USP, EP, JP). Purity levels typically >99% with verified impurity profiles.

• Manufacturing Capacity & Lead Times: Consistent supply and scalability to meet demand fluctuations.

• Pricing & Logistics: Competitive pricing, stable supply chains, and reliable logistics.

• Traceability & Documentation: Batch documentation, Certificates of Analysis (CoA), and compliance with international standards.

Challenges in API Sourcing for MOXEZA

• Supply Chain Disruptions: Geopolitical tensions and pandemic-related disruptions impact manufacturing outputs and logistics.

• Regulatory Hurdles: Variability in regulatory recognition complicates sourcing decisions, particularly for products targeting multiple markets.

• Intellectual Property Considerations: Patents and licensing agreements can restrict certain suppliers from providing specific APIs.

Emerging Trends and Developments

• Shift toward Contract Manufacturing and Partnerships: Increased reliance on CMOs to ensure quality, scalability, and regulatory compliance.

• Development of Synthetic Routes: Advances in green chemistry and process optimization to reduce costs and environmental impact.

• Certificate of Suitability (CEP) and Drug Master Files (DMF): Increasing reliance on regulatory dossiers to streamline approvals and supply chain integrity.

Conclusion

The global landscape of moxifloxacin API suppliers is diverse, with significant capacity in China and India complemented by specialized European suppliers. Key to strategic sourcing are considerations of regulatory compliance, quality standards, manufacturing capacity, and supply chain stability. These factors directly influence the cost, quality, and market sustainability of MOXEZA.

---

Key Takeaways

• Diverse Supply Sources: China and India dominate API production, offering cost-effective options with mature quality standards. European suppliers excel in high-regulatory-compliance contexts.

• Regulatory Alignment: Ensuring API suppliers possess GMP certification, comprehensive regulatory dossiers (e.g., CEPs, DMFs), and transparent quality documentation is critical for pharmaceutical approval processes.

• Supply Chain Stability: Long-term partnerships with verified suppliers reduce risk amid geopolitical or pandemic-induced disruptions.

• Quality Assurance: Stringent purity and impurity profiling ensure ocular safety and therapeutic efficacy for MOXEZA.

• Innovation & Sustainability: Emerging synthetic routes and green chemistry practices present opportunities for cost reduction and environmental compliance.

---

FAQs

1. What are the primary regions supplying moxifloxacin API for ophthalmic products like MOXEZA?
China and India are the leading suppliers globally, offering extensive manufacturing capacity. European firms provide high-regulatory-compliance options, while the U.S. relies on imports and contract manufacturers.

2. How do quality standards impact the choice of API suppliers for ophthalmic applications?
High-quality APIs must meet pharmacopeial standards (USP, EP), with verified impurity profiles and GMP certification. These standards ensure safety, efficacy, and regulatory approval of ophthalmic products.

3. Can further synthetic development reduce the cost of moxifloxacin API?
Yes, advances in green chemistry and optimized synthetic routes can lower production costs, improve environmental sustainability, and meet regulatory requirements more efficiently.

4. What are the risks associated with sourcing API from less-regulated markets?
Risks include variable quality, supply disruptions, and regulatory non-compliance, which can lead to product recalls, regulatory sanctions, or compromised patient safety.

5. How can companies ensure supply chain resilience for moxifloxacin API?
Establishing multi-source relationships, conducting supplier audits, verifying regulatory compliance, and maintaining strategic stockpiles mitigate supply risks.

---

Sources

[1] USP Monograph for Moxifloxacin Hydrochloride
[2] International API supplier directories (e.g., Pharmacompass, Global Sources)
[3] Industry reports on fluoroquinolone API production capacities
[4] Recent regulatory filings and DMFs for moxifloxacin API