Bulk Pharmaceutical API Sources for PHOTREXA VISCOUS IN DEXTRAN 20%

Bulk Pharmaceutical API Sources for PHOTREXA VISCOUS IN DEXTRAN 20%

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		YdXRMDDK@jehDLBNIMIm`XPOC{PH{z\ddqTttrbbbTRTrU@BUSRpqsUUUUSALCIUFCBHjH@
NovoSeek		23666409
Ambinter		BIF4012
TCI (Tokyo Chemical Industry)		R0023

Bulk Active Pharmaceutical Ingredient (API) Sources for Photrexa Viscous in Dextran 20%

Last updated: August 11, 2025

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Introduction

Photorexa Viscous, a crucial component used in ophthalmic treatments, features a formulation of FDA-approved active pharmaceutical ingredients (APIs) tailored for specific therapeutic applications. Central to its formulation is the API responsible for its therapeutic efficacy, particularly in procedures such as corneal collagen cross-linking for keratoconus and other ectatic disorders of the eye. This API, combined with a viscous dextran 20% base, necessitates sourcing from reliable manufacturers to ensure product quality, safety, and regulatory compliance. This article examines the key sources for the bulk API used in Photrexa Viscous, with a focus on the Active Pharmaceutical Ingredient (API) involved, predominantly riboflavin (Vitamin B2).

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Understanding the API in Photrexa Viscous

Photorexa Viscous combines riboflavin (Vitamin B2) with a viscous dextran 20% solution. The primary API is riboflavin, which acts as a photosensitizer. When exposed to UVA light, riboflavin mediates cross-linking of corneal collagen, strengthening the cornea and halting disease progression. The quality, purity, and sourcing of riboflavin are integral to product performance and regulatory approval.

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Major Sources of API for Photrexa Viscous

1. International API Manufacturers

The global pharmaceutical landscape offers several reputable suppliers capable of providing pharmaceutical-grade riboflavin, complying with Good Manufacturing Practices (GMP). Key manufacturers include:

• Yipin Pharmaceutical Co., Ltd. (China)

  A prominent manufacturer specializing in water-soluble vitamins, including pharmaceutical-grade riboflavin. They are GMP-certified and have extensive export experience, supplying APIs to North American and European markets.

• Vitae Pharmaceuticals (India)

  An established pharmaceutical ingredient manufacturer, with GMP accreditation, that produces riboflavin in bulk quantities suitable for ophthalmic formulations. Their API is used in nutraceuticals and pharmaceutical products, adhering to international standards.

• Kyowa Hakko Kirin (Japan)

  A leading Japanese biotech and pharmaceutical company manufacturing high-quality vitamins, including riboflavin, with stringent quality controls and global distribution capabilities.

• FitzChem Ltd. (India)

  Supplies pharmaceutical intermediates and APIs, including riboflavin, with an emphasis on quality assurance and regulatory compliance.

• Laboratorios E. I. S. (Mexico)

  Known for its manufacturing of water-soluble vitamins, offering pharmaceutical-grade riboflavin with regulatory certifications suitable for ophthalmic formulations.

2. North American API Suppliers

• Sigma-Aldrich / MilliporeSigma (USA/Germany)

  Offers pharmaceutical-grade riboflavin (Vitamin B2) suitable for compounding and manufacturing APIs, compliant with pharmacopeial standards, widely used in ophthalmic preparations.

• Par Pharmaceutical (USA)

  Provides bulk APIs, including riboflavin, with GMP certification, catering to pharmaceutical companies developing ophthalmic products.

• Cambridge Major Laboratories / Cambrex

  Supplies high-purity APIs with extensive quality assurance, adapted for specialized biomedical applications, including eye treatments.

3. Regulatory Certification and Quality Standards

Sourcing from GMP-certified manufacturers ensures API quality for eye care formulations. Key attributes include:

• Purity ≥ 98%
• Absence of harmful impurities and contaminants
• Certificate of Analysis (CoA) compliant with pharmacopeial standards (USP, EP, JP)
• Validation of manufacturing processes aligning with FDA, EMA, or other regional regulatory bodies

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Supply Chain Considerations

When selecting sources for riboflavin API, pharmaceutical developers should evaluate:

• Regulatory compliance: Ensure manufacturing facilities hold valid GMP certifications aligned with regional regulatory expectations.
• Documentation: Obtain detailed Certificates of Analysis, Material Safety Data Sheets (MSDS), stability data, and regulatory dossiers.
• Batch consistency: Confirm the supplier’s ability to provide consistent quality across batches.
• Lead times and logistics: Engage with suppliers capable of meeting production schedules and ensuring timely delivery.
• Cost-effectiveness: Balance quality with procurement cost, without compromising safety or efficacy.

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Conclusion

The API critical to Photrexa Viscous’s efficacy—pharmaceutical-grade riboflavin—is procured from reputable international and regional suppliers. These organizations prioritize GMP compliance, high purity standards, and robust quality assurance protocols. Pharmaceutical companies aiming to manufacture or source Photrexa Viscous should rigorously evaluate suppliers based on certification, quality control, and logistical capabilities to maintain product integrity and ensure regulatory compliance.

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Key Takeaways

• Reliable sources for API: Primarily GMP-certified manufacturers in China, India, Japan, and North America supply pharmaceutical-grade riboflavin suitable for ophthalmic use.
• Quality standards: Ensure APIs meet USP, EP, or JP pharmacopeial requirements, with stringent purity and impurity profiles.
• Supplier evaluation: Prioritize suppliers with proven regulatory compliance, consistent batch quality, and strong logistical support.
• Regulatory alignment: Use APIs from certified sources to facilitate smooth regulatory approval processes for ophthalmic product registration.
• Strategic planning: Establish long-term procurement agreements with trusted suppliers to prevent supply disruptions in manufacturing Photrexa Viscous.

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FAQs

1. What is the primary active pharmaceutical ingredient in Photrexa Viscous?
The primary API is riboflavin (Vitamin B2), acting as a photosensitizer in corneal collagen cross-linking procedures.

2. Which regions are the main sources for sourcing riboflavin API?
Major sources include China, India, Japan, and North America, with suppliers holding GMP certification and high-quality standards.

3. What quality attributes should be verified when sourcing riboflavin APIs?
Purity (≥ 98%), absence of harmful impurities, GMP certification, Certificate of Analysis, and compliance with pharmacopeial standards.

4. Why is GMP certification critical for API suppliers?
GMP certification ensures manufacturing consistency, quality control, and adherence to regulatory standards, critical for ophthalmic pharmaceuticals.

5. How can manufacturers ensure continuity of supply for Photrexa Viscous?
By partnering with established, reliable API suppliers with long-term supply agreements, quality assurance programs, and diversified sourcing strategies.

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References

[1] U.S. Pharmacopeia, USP monographs for riboflavin.
[2] European Pharmacopoeia, standards for vitamin B2.
[3] ISO GMP guidelines.
[4] Manufacturer websites, including Yipin Pharmaceutical, Vitae Pharmaceuticals, and Sigma-Aldrich.
[5] Regulatory communications from FDA and EMA regarding ophthalmic APIs.