Bulk Pharmaceutical API Sources for RAVICTI

Bulk Pharmaceutical API Sources for RAVICTI

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS030238862
MuseChem		I006985
MedChemexpress MCE		HY-B2087
AbaChemScene		CS-0017499
AA BLOCKS		AA003APB
Molport		MolPort-046-197-231

Bulk Active Pharmaceutical Ingredient (API) Sources for Ravicti (Guanidine Acetate)

Last updated: July 27, 2025

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Overview of Ravicti and Its API

Ravicti (generic name: glycerol phenylbutyrate) is a prescription medication used to manage hepatic encephalopathy stemming from urea cycle disorders. Its efficacy hinges on the quality and availability of its active pharmaceutical ingredient (API), glycerol phenylbutyrate, a proprietary compound, and in some instances, the API utilized in the manufacturing process is a precursor or component such as phenylacetic acid or related intermediates.

While Ravicti’s commercial formulation primarily involves proprietary blends, its core API sourcing relates closely to key chemical intermediates, potentially including phenylacetate derivatives. Due to the complexity and proprietary nature of Ravicti’s synthesis, sourcing APIs generally involves specialized chemical suppliers with strict quality controls.

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Global API Market for Ravicti: Key Sources and Suppliers

1. Manufacturing of API Components: Phenylacetic Acid and Related Intermediates

Ravicti’s API primarily involves phenylbutyrate derivatives, which are synthesized from precursors such as phenylacetic acid and related compounds.

• Major Suppliers:

  • BASF—Global leader in specialty chemicals and pharmaceutical intermediates, including phenylacetic acid and derivatives. BASF’s robust manufacturing network ensures high-quality API precursors for pharmaceutical companies worldwide.

  • Lanxess—Offers a range of chemical intermediates; some sources indicate their involvement in phenylacetic acid and related aromatic compounds essential for API synthesis.

  • NEO-Chemicals—Specialized in organic synthesis, offering custom chemical intermediates, including phenylacetic acid, for API manufacturing.

• Emerging Suppliers:

  • GEO Specialty Chemicals—Provides intermediates and chemical raw materials, with a focus on pharmaceutical-grade compounds.

  • Tianjin Teda Chemical Co.—A Chinese supplier known for phenylacetic acid and derivatives, offering competitive pricing but requiring thorough quality validation.

2. API Drug Substance Producers

While specific companies producing glycerol phenylbutyrate as Ravicti’s API are often proprietary and may operate under confidential agreements with AbbVie, some generic API manufacturers are capable of producing analogous compounds.

• Cambridge Commodities—Supplies pharmaceutical-grade intermediates and API components, possibly including phenylbutyrate derivatives, with integrated quality assurance.

• Ningbo Inno Pharmchem Co. Ltd.—A Chinese API manufacturer with experience producing phenylacetic acid and related compounds for pharmaceutical applications.

• South Korean and Indian API Manufacturers—Numerous firms in these regions have scaled API production capacities for aromatic acids and amino acid derivatives, which can be tailored for Ravicti’s API.

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Sourcing Considerations and Regulatory Implications

• Quality Standards: Suppliers must adhere to Good Manufacturing Practices (GMP) and obtain certifications from regulatory authorities such as the FDA, EMA, or equivalent agencies.

• Supply Chain Reliability: Given Ravicti’s critical application in rare diseases, stable and compliant API sources are vital. Disruptions could impact drug availability, emphasizing the importance of diversified sourcing.

• Cost Competitiveness: API costs significantly influence final drug pricing. China and India dominate the API manufacturing landscape, offering cost advantages but necessitating rigorous quality audits.

• Intellectual Property (IP): Ravicti’s proprietary formulation and synthesis route limit API sourcing options to licensed suppliers or custom manufacturers with licensing agreements.

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Supply Chain Challenges and Market Dynamics

The API sourcing landscape for Ravicti is characterized by:

• Intellectual property restrictions that limit open-market sourcing.

• Regulatory scrutiny over sourcing from certain regions.

• Limited suppliers specializing in phenylbutyrate derivatives due to complex synthesis and quality requirements.

• Market consolidation as larger pharmaceutical companies acquire or develop in-house API manufacturing capabilities to secure supply chains.

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Future Trends in API Sourcing for Ravicti

• Vertical Integration: Manufacturers may increasingly bring API production in-house to ensure quality and supply security, especially for rare disease medications like Ravicti.

• Advanced Synthesis Methods: Improvements in chemical synthesis could enable more efficient, cost-effective API production, broadening supplier options.

• Regional Expansion: Southeast Asian and Middle Eastern manufacturers are exploring expansion into pharmaceutical intermediates, potentially increasing regional supplies.

• Regulatory Harmonization: Global standards and streamlined approval processes may facilitate switching or diversifying API sources with fewer regulatory hurdles.

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Conclusion

The API sourcing landscape for Ravicti, centered on glycerol phenylbutyrate synthesis, is shaped by a combination of established chemical suppliers, regional manufacturing capabilities, regulatory frameworks, and supply chain considerations. Major multinational chemical companies such as BASF and Lanxess continue to serve as primary suppliers of key intermediates like phenylacetic acid, while a network of regional manufacturers offers additional sourcing options. Ensuring high-quality, compliant, and reliable API supplies remains paramount to maintaining Ravicti’s therapeutic availability, especially given its niche market in urea cycle disorders.

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Key Takeaways

• The core API components for Ravicti relate primarily to phenylacetic acid derivatives and proprietary glycerol phenylbutyrate synthesis pathways.

• Leading global chemical suppliers, including BASF and Lanxess, provide critical intermediates, but regional manufacturers also play significant roles.

• Regulatory compliance, supply stability, and cost-efficiency drive sourcing strategies for Ravicti’s API.

• Industry trends point toward increased vertical integration and regional manufacturing expansion to secure supply chains.

• Due to proprietary synthesis routes, sourcing remains constrained to licensed and highly regulated suppliers.

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FAQs

1. Who are the leading global suppliers of phenylacetic acid for pharmaceutical APIs?
BASF and Lanxess are among the top global suppliers offering pharmaceutical-grade phenylacetic acid, essential for API synthesis in drugs like Ravicti.

2. How does regional manufacturing impact API supply for Ravicti?
Regional manufacturers, particularly in China and India, contribute to cost-effective API production but require rigorous quality validation to ensure compliance with international standards.

3. What regulatory considerations are crucial when sourcing APIs for Ravicti?
Suppliers must demonstrate GMP compliance, obtain certifications from relevant health authorities, and maintain quality assurance to meet strict pharmaceutical standards.

4. Are there alternative pathways for API production in Ravicti manufacturing?
Advancements in synthetic chemistry and the emergence of new chemical suppliers may enable alternative production pathways, provided they meet regulatory and quality criteria.

5. What risks are associated with API sourcing for niche medications like Ravicti?
Risks include supply disruptions due to regulatory changes, geopolitical issues, quality inconsistencies, and dependence on a limited number of specialized suppliers.

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Sources

[1] Market intelligence reports on pharmaceutical intermediates, 2022.
[2] Chemical supplier profiles from industry databases.
[3] Industry analyses on API manufacturing trends and regional capacities.