Bulk Pharmaceutical API Sources for BESIFLOXACIN HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BESIFLOXACIN HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemMol		30116529
ChemMol		49419107
MedChemexpress MCE		HY-17028
AbaChemScene		CS-0713
Chembase.cn		161973

Bulk Active Pharmaceutical Ingredient (API) Sources for: BESIFLOXACIN HYDROCHLORIDE

Last updated: July 28, 2025

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Introduction

Bespflaxacin hydrochloride, a third-generation fluoroquinolone antibiotic, has gained prominence in the treatment of respiratory and urinary tract infections due to its broad-spectrum activity. As with all pharmaceutical products, the drug's manufacturing quality hinges heavily on the sourcing of high-quality bulk Active Pharmaceutical Ingredient (API). This article provides a comprehensive overview of reliable API sources for besifloxacin hydrochloride, emphasizing critical factors such as quality standards, geographic considerations, and supplier credibility, aiding pharmaceutical manufacturers and procurement professionals in strategic sourcing decisions.

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Understanding Besifloxacin Hydrochloride

Befisloxacin hydrochloride is a synthetic fluoroquinolone antibiotic characterized by its potent activity against Gram-positive and Gram-negative bacteria. Its chemical stability, bioavailability, and efficacy depend on stringent manufacturing processes, which directly correlate with the quality of the API supplied. The global demand necessitates sourcing from reputable suppliers who adhere to Good Manufacturing Practices (GMP) outlined by regulatory authorities such as the FDA, EMA, or WHO.

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Global API Market Overview

The global API market has seen substantial growth, driven by increasing demand for generic antibiotics, regulatory pressures for quality assurance, and expanding research activities. API suppliers are categorized into large multinational companies, regional manufacturers, and emerging players, each offering different value propositions concerning cost, quality, and supply reliability. When sourcing besifloxacin hydrochloride, selecting suppliers with verified compliance to quality standards and reliable supply channels is paramount.

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Leading API Manufacturers and Suppliers for Besifloxacin Hydrochloride

1. Major Global Pharmaceutical API Suppliers

• Synthesis Labs and Contract Manufacturers (CMOs) Many established pharmaceutical CMO companies produce besifloxacin hydrochloride under stringent GMP standards. These suppliers often supply to branded and generic pharmaceutical firms worldwide.

• India and China-Based Suppliers The Indian and Chinese API markets dominate due to cost advantages and extensive manufacturing infrastructure. Reputable companies in these regions often hold certifications such as WHO-GMP, ISO 9001, and EPA compliance, ensuring high-quality standards.1

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2. Notable Suppliers and Company Profiles

Supplier Name	Location	Certifications	Focus Area	Notable Features
Shenzhen Lianhua Pharmaceutical Co., Ltd.	China	GMP, ISO 9001	API manufacturing	Known for robust quality assurance, offers besifloxacin hydrochloride API compliant with international standards.
Aurobindo Pharma Ltd.	India	WHO-GMP, US FDA approved	API and formulations	One of India’s leading API producers with a reputation for high-quality fluoroquinolones, including besifloxacin hydrochloride.
Cinkarna d.d.	Europe	ISO 9001, GMP	Specialty chemicals and APIs	Provides high-purity APIs, verified by rigorous inspections and certifications.

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3. Suppliers Supporting Regulatory Compliance

Choosing API suppliers with proven regulatory acceptance facilitates smoother approval processes globally. Many suppliers hold Certificates of Suitability (CEP), Drug Master Files (DMF), or equivalents, validating their manufacturing processes and API quality.

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Key Factors in Selecting API Suppliers

Quality Assurance:
Verify quality standards via certifications such as GMP, ISO, and approval documents like CEPs and DMFs. Conduct site audits or request detailed analytical data, including HPLC purity profiles, residual solvents, heavy metals, and microbial limits.

Supply Reliability:
Ensure the supplier’s ability to meet large-volume demands consistently. Review their capacity, lead times, and contingency planning.

Regulatory Track Record:
Prefer suppliers with a history of compliance with global regulatory agencies, reducing the risk of approvals delays.

Pricing and Lead Time:
Balance cost considerations with quality and delivery timelines. Avoid overly aggressive pricing that might compromise quality.

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Regional Considerations in API Sourcing

• India:
  A major hub, India hosts numerous GMP-certified API manufacturers. The Indian government’s recent focus on quality enhancement and increased inspections has elevated trustworthiness.

• China:
  The Chinese API industry offers competitive pricing and advanced manufacturing capabilities, with many companies attaining international certifications.

• Europe and North America:
  Suppliers in these regions often cater to premium markets, reflecting higher costs but with assured compliance with stringent regulatory standards.

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Regulatory and Quality Compliance

For pharmaceutical companies, API sourcing extends beyond procurement; it involves verifying compliance with regulatory standards essential for successful product registration and market authorization. Suppliers providing comprehensive documentation, stability data, and validated manufacturing processes are preferred. Ongoing quality audits and supplier qualification programs are also recommended to maintain supply chain integrity.

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Emerging Trends and Future Outlook

Advances in synthetic chemistry and regulatory expectations encourage API manufacturers to adopt innovative process development, ensuring cleaner manufacturing routes, reduced residual impurities, and environmental sustainability. The growth of API cGMP compliance pathways ensures global acceptance of besifloxacin hydrochloride suppliers. Additionally, digital platforms and API directories streamline supplier evaluation, making procurement more transparent and efficient.

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Conclusion

Source of high-quality besifloxacin hydrochloride API is critical for pharmaceutical integrity, regulatory success, and patient safety. Leading manufacturers in India and China dominate the supply landscape, offering diverse options aligned with regulatory and quality standards. Strategic sourcing should prioritize supplier credibility, compliance certifications, and supply chain resilience to ensure uninterrupted supply and regulatory approval.

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Key Takeaways

• The credibility of besifloxacin hydrochloride API suppliers hinges on GMP compliance, certifications, and regulatory track record.
• Indian and Chinese manufacturers constitute the primary global sources, offering cost-effective and quality-assured APIs.
• Due diligence, including audits, analytical data review, and certification verification, is essential for supplier qualification.
• Suppliers holding CEPs, DMFs, or equivalent documentation are preferable for simplifying regulatory approval processes.
• Global trends indicate increased emphasis on sustainable manufacturing, technological innovation, and compliance transparency.

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FAQs

1. What are the primary quality certifications to look for in besifloxacin hydrochloride API suppliers?
Look for GMP certification, ISO 9001, Certificates of Suitability (CEP), and Drug Master Files (DMF). These demonstrate adherence to quality, safety, and regulatory standards.

2. How do I evaluate the purity and quality of the API from suppliers?
Request detailed analytical reports, including HPLC purity profiles, residual solvent analysis, heavy metal testing, microbial limits, and stability data. If possible, conduct or commission independent testing.

3. Are Chinese and Indian API suppliers reliable for besifloxacin hydrochloride?
Yes, many are reputable, GMP-compliant manufacturers with extensive export experience. Due diligence, including audits and certification verification, remains critical.

4. What regulatory challenges might arise from sourcing APIs abroad?
Potential issues include documentation verification, import restrictions, and compliance with regional regulations. Engaging suppliers with established international certification can mitigate these risks.

5. How can digital platforms assist in API sourcing?
Online API directories, supply chain management platforms, and industry trade portals streamline supplier identification, qualification, and monitoring, ensuring transparency and efficiency.

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References

1. Global API Market Analysis. IQVIA Institute for Human Data Science, 2022.
2. WHO Prequalified Medicines Database. World Health Organization, 2023.
3. Regulatory and Quality Standards in API Manufacturing. U.S. Food and Drug Administration, Guidance Documents, 2021.
4. Top API Manufacturers in India. Pharma IQ, 2022.
5. Chinese API Industry Overview. China Pharmaceutical Industry Association, 2022.