Bulk Pharmaceutical API Sources for NIMBEX PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for NIMBEX PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-987-490
BroadPharm		W-60404
AbaChemScene		CS-2471

Bulk Active Pharmaceutical Ingredient (API) Sources for NIMBEX PRESERVATIVE FREE

Last updated: August 3, 2025

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Introduction

NIMBEX PRESERVATIVE FREE is a topical anesthetic and anti-inflammatory agent primarily used in ophthalmic and ophthalmic surgery applications. The API responsible for its therapeutic effects is Bupivacaine Hydrochloride, a long-acting local anesthetic, which, when produced without preservatives, meets the demands for sterile, preservative-free formulations suitable for sensitive ophthalmic use and injections. Securing reliable bulk API sources for NIMBEX PRESERVATIVE FREE entails evaluating reputable manufacturers that comply with strict regulatory standards, ensuring high purity, stability, and consistent supply.

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Understanding the API: Bupivacaine Hydrochloride

Chemical Profile:
Bupivacaine hydrochloride is a highly potent amide-type local anesthetic with sustained activity, characterized by its chemical stability and low systemic toxicity. Its production must meet pharmaceutical-grade standards (USP, EP, or JP) to ensure safety and efficacy in preservative-free formulations.

Application in NIMBEX PRESERVATIVE FREE:
As the active component, Bupivacaine Hydrochloride's preservative-free formulation is critical for ophthalmic procedures, reducing risks of preservative-induced toxicity, and ensuring patient safety during intraocular, periocular, or injectable applications.

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Global API Suppliers for Bupivacaine Hydrochloride

1. Hikma Pharmaceuticals

• Overview:
  Hikma is a major manufacturer of generic pharmaceuticals, including injectable anesthetics like Bupivacaine Hydrochloride. Their API manufacturing complies with rigorous international standards, including FDA cGMP and EMA regulations.

• Advantages:

  • Consistent supply chain
  • High-quality API meeting pharmacopeial standards
  • Proven track record in sterile injectable API manufacturing

• Certifications & Quality:
  ISO 9001, cGMP compliance, and regulatory approvals from major global health authorities.

2. Sino Biopharmaceutical Limited

• Overview:
  A leading Chinese pharmaceutical producer with extensive experience in active pharmaceutical ingredients, including local anesthetics.

• Advantages:

  • Competitive pricing
  • Large-scale manufacturing capabilities
  • Dedicated API manufacturing facilities adhering to international standards

• Certifications & Quality:
  ISO, cGMP, and Chinese SFDA approval; efforts underway for widespread international regulatory acceptance.

3. Jiangsu Hengrui Medicine Co., Ltd.

• Overview:
  A prominent Chinese biotech and pharmaceutical entity that supplies high-purity APIs, including Bupivacaine.

• Advantages:

  • Advanced chemical synthesis technology
  • High product purity and batch-to-batch consistency
  • Active engagement with regulatory authorities

• Certifications & Quality:
  ISO, cGMP, and CE certification; data on stability and impurity profile available upon request.

4. Hovid Berhad

• Overview:
  A Malaysian pharmaceutical company with a global presence, specializing in local anesthetics and injectable APIs.

• Advantages:

  • Long-standing experience
  • Focus on quality and reliable supply
  • Established export channels

• Certifications & Quality:
  ISO 9001, cGMP compliance, and certification for pharmaceutical export.

5. Shanghai Saike Pharmaceutical Co., Ltd.

• Overview:
  Specialized in the synthesis of local anesthetics and injectable APIs with a focus on Chinese and international markets.

• Advantages:

  • Competitive pricing
  • Good manufacturing practices
  • Ability to tailor API specifications for preservative-free formulations

• Certifications & Quality:
  ISO, cGMP, and certification aligned with international standards.

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Key Considerations for Selecting API Suppliers

Regulatory Compliance:
Ensure APIs meet pharmacopeial standards (USP, EP, JP) or equivalent and possess relevant certifications (ISO, cGMP). For ophthalmic use, strict adherence to sterilization and purity standards is imperative.

Purity & Impurity Profile:
API manufacturers must provide analytical data confirming high purity (>99%) and minimal residual solvents or impurities. Stability data ensures API integrity during storage and handling.

Supply Chain Reliability:
Long-term supply commitments with scalable manufacturing capacity reduce risk associated with shortages or delays—vital in preserving the continuous production of preservative-free formulations.

Pricing & Contract Flexibility:
Competitive pricing, coupled with flexible contracting options, facilitates compliance with global procurement strategies while maintaining quality standards.

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Procurement Challenges and Strategies

Regulatory Approval and Documentation:
Bringing API from foreign manufacturers into certain jurisdictions often involves rigorous documentation, including DMFs (Drug Master Files) and Certificates of Analysis (CoA). Engaging suppliers with established regulatory approvals expedites registration processes.

Quality Assurance & Audits:
Conducting factory audits and requesting detailed quality assurance reports optimize procurement decisions.

Custom Synthesis & Formulation Compatibility:
API suppliers capable of customizing specifications (e.g., particle size, sterility standards) improve formulation compatibility for preservative-free ophthalmic products.

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Future Outlook

The demand for preservative-free APIs, especially in ophthalmology, is projected to escalate due to increasing awareness of preservative toxicity. Manufacturers that invest in advanced synthesis technologies and quality assurance will become preferred partners. Regulatory harmonization efforts may facilitate smoother international procurement, expanding the potential vendor pool.

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Key Takeaways

• High-quality API sourcing is critical for manufacturing preservative-free NIMBEX, primarily relying on Bupivacaine Hydrochloride from reputable suppliers.
• Global manufacturers like Hikma, Sino Biopharmaceutical, Jiangsu Hengrui, Hovid, and Shanghai Saike offer reliable sources, each with varying advantages concerning cost, capacity, and compliance.
• Regulatory compliance (ISO, cGMP, pharmacopeia standards) and quality assurance are paramount for preservative-free ophthalmic formulations.
• Supply chain stability and customization services play essential roles in ensuring consistent production and regulatory approval.
• Strategic procurement should blend cost considerations with quality and regulatory track records to mitigate risks associated with API sourcing.

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FAQs

1. Can I source Bupivacaine Hydrochloride API from multiple suppliers simultaneously?
Yes, diversifying suppliers reduces supply risks and ensures continuity, provided all sources meet the same quality and regulatory standards.

2. What are the regulatory hurdles when importing API for preservative-free ophthalmic use?
Regulatory hurdles include meeting pharmacopeial standards, providing comprehensive documentation (DMFs, CoA), and obtaining necessary approvals from regulatory agencies such as the FDA or EMA.

3. How does API purity impact preservative-free formulations?
High purity minimizes impurities that could compromise stability or cause adverse reactions, which is especially critical in preservative-free ophthalmic products sensitive to contamination.

4. Are Chinese API manufacturers a reliable source?
Many Chinese manufacturers adhere to international GMP and ISO standards. Due diligence, including audits and certification verification, is essential to ensure compliance and quality.

5. What considerations are necessary for sourcing APIs for sterile, preservative-free formulations?
Sterility assurance, controlled manufacturing environments, validated sterilization processes, and product stability studies are necessary to ensure API suitability for preservative-free applications.

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References

1. United States Pharmacopeia (USP) monograph for Bupivacaine Hydrochloride.
2. European Pharmacopoeia (EP) standards for Local Anesthetics.
3. FDA and EMA manufacturing and quality guidelines for APIs.
4. Industry reports on API manufacturing trends and quality standards.