Bulk Pharmaceutical API Sources for GENTIAN VIOLET

Bulk Pharmaceutical API Sources for GENTIAN VIOLET

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jkopBBH]FBHAtIpJQPiYQQQII[IQPTduJujef`@@Bjj@@@
Sigma-Aldrich		G2039_SIAL
Sigma-Aldrich		HT901_SIGMA
Biosynth		C-8650

Bulk Active Pharmaceutical Ingredient (API) Sources for GENTIAN VIOLET

Last updated: July 27, 2025

Introduction

Gentian Violet, also known as crystal violet or methylrosaniline chloride, is a triarylmethane dye historically used as an antiseptic and antifungal agent. Despite reduced usage in modern medicine, it remains prevalent in certain applications like veterinary medicine, histology, and microbiology. The quality and supply of Gentian Violet API are critical for these niche markets, necessitating a comprehensive understanding of international bulk API sources.

Overview of Gentian Violet API

Gentian Violet is synthesized via chemical processes involving the condensation of N,N-dimethylaniline derivatives with formaldehyde, followed by chlorination. The production process is complex, requiring strict quality controls to ensure purity, stability, and consistency. As a dye-based compound, it presents unique challenges related to toxicity and regulatory scrutiny, influencing supplier selection.

Global API Suppliers for Gentian Violet

1. Indian Suppliers

India dominates the global market for dye APIs, including Gentian Violet, owing to its robust chemical manufacturing sector and lower production costs.

• Vikas Chemicals Limited
  A prominent supplier specializing in dyes and intermediates. Vikas Chemicals offers pharmaceutical-grade Gentian Violet API compliant with international standards such as USP, BP, and EP. The company emphasizes quality control, with certifications including ISO 9001 and ISO 14001.

• Sudarshan Chemical Industries Ltd.
  Known for chemical manufacturing for dyes and pigments, this firm supplies qualified Gentian Violet sources for medical and veterinary use. Their manufacturing units are GMP-compliant, ensuring consistency and purity.

• Jigish Chemicals Pvt. Ltd.
  Specializes in dye intermediates with exports to various regions. Their Gentian Violet API is used in microbiology laboratories, with rigorous quality assurance.

2. Chinese Suppliers

China remains a significant exporter of dye APIs, including Gentian Violet, leveraging extensive chemical manufacturing infrastructure.

• Shandong Sanfangyuan Chemical Co., Ltd.
  Provides pharmaceutical-grade Gentian Violet with GMP certification. The company focuses on consistent API quality, with detailed analytical data accompanying each batch.

• Jiangsu Sopo Chemical Co., Ltd.
  Produces various dyes and intermediates, including Gentian Violet API. They offer competitive pricing and adherence to international standards, including USP and BP.

• Zhejiang Runtu Co., Ltd.
  Offers dye intermediates and APIs with quality assurance for medical and industrial applications; their Gentian Violet API adheres to required purity specifications.

3. European and North American Sources

While European and North American manufacturers are less prominent in dye API production due to historical shifts toward China and India, some suppliers provide high-quality, certified APIs.

• Sigma-Aldrich/Merck Group (USA/Europe)
  Supplies laboratory-grade Gentian Violet for research purposes. Their APIs meet stringent regulatory standards; however, commercial bulk sources for pharmaceutical-grade APIs are limited.

• LKT Laboratories, Inc. (USA)
  Offers Gentian Violet for research and compounding, compliant with USP standards. They focus on specialty chemicals rather than bulk API production.

4. Regulatory Considerations and Certifications

Suppliers must ensure compliance with international pharmaceutical standards, including USP, BP, or EP monographs. Additionally, Good Manufacturing Practices (GMP) certification is essential for APIs intended for clinical or veterinary use. Suppliers like Vikas Chemicals and Shandong Sanfangyuan have obtained relevant certifications, fostering greater confidence among purchasers.

Supply Chain Challenges

• Quality Consistency: Variability in dye purity can impact efficacy and safety. Vetting suppliers' analytical profiles, including HPLC and microbial testing, is crucial.

• Regulatory Approvals: Some regions require explicit registration and approval of APIs. Engaging with suppliers that have existing approvals simplifies market entry.

• Pricing Fluctuations: Cost considerations vary, with Indian and Chinese suppliers generally offering more competitive pricing, but regulatory hurdles may influence procurement strategies.

• Environmental and Safety Standards: Due to Gentian Violet’s potential mutagenicity, suppliers adhering to environmental safety standards are preferable.

Market Trends and Future Outlook

While Gentian Violet overtaken by newer antifungal agents, specialized applications sustain demand. The API supply chain remains stable, primarily anchored in India and China, driven by manufacturing efficiencies and lower costs. Innovations in synthesis and purification techniques could elevate quality standards further, expanding potential applications under more stringent regulatory regimes.

Conclusion

The global supply landscape for Gentian Violet API centers predominantly around India and China, with European and North American sources limited to research-grade supplies. Manufacturers should prioritize suppliers with verified GMP compliance, consistent analytical quality, and regulatory certifications to ensure suitability for pharmaceutical and veterinary applications. The availability of certified APIs fosters confidence in safety and efficacy, vital for maintaining compliance and market acceptance.

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Key Takeaways

• Indian and Chinese suppliers dominate the Gentian Violet API market, offering cost-effective, high-quality options.
• Regulatory compliance (GMP, USP/BP standards) is critical for pharmaceutical applications; suppliers with recognized certifications are preferred.
• Quality consistency and purity assurance are vital, especially given Gentian Violet’s potential toxicity and regulatory scrutiny.
• Supply chain stability hinges on rigorous supplier vetting, environmental compliance, and clear analytical documentation.
• Market demand persists mainly in niche applications, with future growth contingent on developments in purification processes and regulatory acceptance.

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FAQs

1. Is Gentian Violet API suitable for pharmaceutical production?
Yes, if sourced from suppliers meeting GMP standards and holding appropriate regulatory certifications such as USP, BP, or EP compliance.

2. What are the major regions producing Gentian Violet API?
India and China are the primary producers and exporters of bulk Gentian Violet API.

3. What are key quality considerations for sourcing Gentian Violet?
Purity, stability, impurity profile, and regulatory compliance are critical factors influencing API quality.

4. Are there international suppliers offering research-grade Gentian Violet APIs?
Yes, companies like Sigma-Aldrich provide research-grade APIs, but these may not meet pharmaceutical-grade requirements.

5. How do environmental regulations impact Gentian Violet API suppliers?
Strict environmental standards influence manufacturing practices; suppliers adhering to environmental guidelines minimize risks of contamination and regulatory issues.

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References

[1] International Pharmaceutical Excipients Council (IPEC). Guidelines on Active Pharmaceutical Ingredient manufacturing standards.
[2] U.S. Pharmacopeia (USP). Monograph on Gentian Violet.
[3] Indian Department for Promotion of Industry and Internal Trade. Chemical Industry Profile (2021).
[4] China National Pharmaceutical Industry Information Center. Report on Dye API Production Capacities.