Share This Page
Suppliers and packagers for generic pharmaceutical drug: GLYCEROL PHENYLBUTYRATE
✉ Email this page to a colleague
GLYCEROL PHENYLBUTYRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284 | NDA | Horizon Therapeutics USA, Inc. | 75987-050-06 | 1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE | 2013-02-28 |
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284 | NDA | Horizon Therapeutics USA, Inc. | 75987-050-07 | 4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE | 2013-02-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug Glycerol Phenylbutyrate: A Comprehensive Analysis
Glycerol phenylbutyrate, marketed under the brand name Ravicti®, is a critical therapeutic agent for managing urea cycle disorders (UCDs). Its supplier landscape spans global manufacturers, distributors, and regulatory frameworks that shape accessibility and pricing. This report examines the key players, regulatory milestones, pricing dynamics, and regional distribution channels underpinning the glycerol phenylbutyrate supply chain.
Regulatory Landscape and Market Authorization
Orphan Drug Designations and Global Approvals
Glycerol phenylbutyrate has garnered orphan drug status in multiple jurisdictions, a designation that incentivizes development for rare diseases. In Japan, OrphanPacific secured orphan designation for glycerol phenylbutyrate in December 2024, building on its existing portfolio of UCD treatments like sodium phenylbutyrate (Buphenyl®) [3]. This designation followed a May 2022 exclusive licensing agreement with Immedica Pharma AB, enabling OrphanPacific to develop and commercialize the drug in Japan [12]. In the U.S., the FDA granted Fast Track designation in 2010, accelerating its path to approval for UCDs [11]. These regulatory milestones underscore the drug’s strategic importance in addressing unmet medical needs.
Compliance with Manufacturing Standards
Manufacturers must adhere to Good Manufacturing Practices (GMP) and regional regulatory requirements. For instance, the FDA mandates GMP compliance for U.S. suppliers, while the European Medicines Agency (EMA) enforces similar standards in the EU [9]. Certifications such as USDMF (U.S. Drug Master File), CEP (Certificate of Suitability to the European Pharmacopoeia), and JDMF (Japanese Drug Master File) are critical for market entry. Indian manufacturers like Biophore India Pharmaceuticals Pvt Ltd and Lupin Ltd highlight their GMP compliance and USDMF submissions to serve global markets [1][4].
Key Manufacturers and Suppliers
Asia-Based Production Hubs
India and China dominate the API (active pharmaceutical ingredient) manufacturing landscape. Biophore India Pharmaceuticals Pvt Ltd and Nuray Chemicals Private Limited are prominent Indian suppliers, offering glycerol phenylbutyrate API with USDMF and CEP certifications [1][4]. In China, TargetMol Chemicals Inc. and Shanghai Acmec Biochemical Technology Co., Ltd. provide high-purity glycerol phenylbutyrate for research and commercial use, with prices ranging from $39.00 to $80.00 per milligram [10].
Israeli and European Partnerships
TAPI (Teva Active Pharmaceutical Ingredients), headquartered in Israel, supplies glycerol phenylbutyrate API produced in Israel, targeting markets in Europe and beyond. Their offerings comply with FDA and EMA standards, as evidenced by audit reports and GMP certifications [2][9]. Immedica Pharma AB, a European developer, licenses the drug to regional partners, including OrphanPacific for Japanese distribution [12].
Pricing Dynamics and Market Trends
Factors Influencing API Costs
The price of glycerol phenylbutyrate API fluctuates based on production scale, regulatory compliance, and geopolitical factors. For example, Indian exporters quoted prices of approximately $36 per kilogram in December 2024 for shipments to the Czech Republic, though currency fluctuations and supply chain disruptions could alter these figures [2]. Additionally, orphan drug exclusivity in markets like Japan and the U.S. allows manufacturers to maintain higher price points due to limited competition [3][11].
Regional Price Variations
In India, Indian Pharma Network (IPN) distributes Ravicti® oral liquid at competitive prices, leveraging local manufacturing to reduce costs [5]. Conversely, U.S. and European markets face higher prices due to stringent regulatory requirements and longer supply chains. Research-grade glycerol phenylbutyrate, such as the sigma-2 receptor ligand offered by Adooq, commands premium pricing at $39.00–$80.00 per milligram, reflecting its niche application in oncology research [6].
Distribution Networks and Strategic Partnerships
Direct Manufacturer-to-Buyer Channels
Platforms like PharmaCompass and PharmaOffer facilitate direct connections between buyers and suppliers. PharmaCompass lists 11 manufacturers and distributors, enabling users to filter by certifications, pricing, and production regions [1][4]. PharmaOffer’s trade data reveals India’s role as a key exporter, with TEVA CZECH importing 11.72 kilograms of API in December 2024 [2].
Specialty Distributors and Clinical Access
Indian Pharma Network (IPN) exemplifies a specialty distributor focused on oncology and rare disease therapies. IPN’s network spans 15,000 patients and includes partnerships with global suppliers to import FDA-approved drugs under named-patient programs [5]. Similarly, OrphanPacific’s collaboration with Immedica ensures Japanese patients access Ravicti® through controlled clinical trials and phased commercialization [12].
Emerging Applications and Future Directions
Expansion into New Therapeutic Areas
While UCDs remain the primary indication, glycerol phenylbutyrate is under investigation for cystic fibrosis and spinal muscular atrophy. Horizon Therapeutics plc and National Jewish Health are exploring its hepatoprotective properties, which could broaden its supplier base [7]. Adooq’s research-grade product highlights potential applications in cancer therapy, targeting the sigma-2 receptor with 99% HPLC purity [6].
Impact of Generic Competition
The 2023 U.S. patent expiration for Ravicti® has spurred interest in generic alternatives. Indian manufacturers like Biophore and Lupin are poised to enter the market, potentially reducing prices by 30–50% [4][9]. However, regulatory hurdles, including bioequivalence studies, may delay generic approval until 2026.
Challenges in Supply Chain Management
Regulatory Heterogeneity
Divergent regulatory requirements across regions complicate supplier operations. For example, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) mandates additional stability testing compared to the FDA, increasing time-to-market for new entrants [3][12]. Similarly, the EU’s Falsified Medicines Directive requires serialization and traceability measures, raising production costs for exporters [9].
Raw Material Sourcing
Key precursors like phenylbutyric acid face supply constraints due to environmental regulations in China. In 2024, a crackdown on chemical waste disposal reduced phenylbutyric acid output by 15%, prompting suppliers to seek alternative sources in India and South Korea [10].
Conclusion
The glycerol phenylbutyrate supply chain is shaped by a complex interplay of regulatory rigor, geographic specialization, and evolving therapeutic applications. While Indian and Chinese manufacturers dominate API production, strategic partnerships with European and Japanese firms ensure global distribution. Pricing remains sensitive to regulatory exclusivity and raw material availability, with generics poised to disrupt the market post-2026. Future advancements in UCD therapy and oncology research will further influence supplier strategies, emphasizing the need for agile, compliant manufacturing frameworks.
Key Takeaways
- Regulatory Milestones: Orphan drug designations in Japan (2024) and FDA Fast Track status (2010) underscore glycerol phenylbutyrate’s therapeutic value.
- Manufacturing Hubs: India and China lead API production, with Biophore India and TargetMol Chemicals as key suppliers.
- Pricing Dynamics: Costs range from $36/kg in bulk API to $80/mg for research-grade material, influenced by regulatory and market factors.
- Distribution Networks: Platforms like PharmaCompass bridge buyers and suppliers, while specialty distributors like IPN enhance clinical access.
- Future Trends: Generic competition and new indications for cystic fibrosis and oncology could reshape the supplier landscape by 2030.
FAQs
-
What certifications are required to supply glycerol phenylbutyrate?
Suppliers must comply with GMP, USDMF (U.S.), and CEP (EU) standards, varying by region [1][9]. -
How does orphan drug status impact pricing?
Orphan designation grants market exclusivity, allowing higher prices due to limited competition [3][11]. -
Which companies dominate API manufacturing in India?
Biophore India Pharmaceuticals and Lupin Ltd are prominent Indian API manufacturers [4][9]. -
What role do specialty distributors play?
Distributors like Indian Pharma Network enable access to FDA-approved drugs via named-patient programs [5]. -
When will generics enter the market?
Generic glycerol phenylbutyrate may launch post-2026, pending bioequivalence studies and patent expirations [9].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/glycerol-phenylbutyrate
- https://pharmaoffer.com/api-excipient-supplier/urological-agents/glycerol-phenylbutyrate
- https://www.orphanpacific.com/upload/news_en/20241225104224wYfXBzaNEa6ZNP1U.pdf/Press%20release%20for%20Ravicti%20ODD.pdf
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/glycerol-phenylbutyrate-usan
- https://indianpharmanetwork.co.in/medicines/product/ravicti-price-india/
- https://www.adooq.com/glycerol-phenylbutyrate.html
- https://adisinsight.springer.com/drugs/800026968
- https://mcgs.bcbsfl.com/MCG?mcgId=09-J1000-98&pv=false
- https://pharmaoffer.com/api-excipient-supplier/urological-agents/glycerol-phenylbutyrate/fda
- https://www.chemicalbook.com/ChemicalProductProperty_EN_CB73049827.htm
- https://www.biospace.com/hyperion-therapeutics-receives-fda-fast-track-designation-for-glycerol-phenylbutyrate-for-the-treatment-of-urea-cycle-disorders
- https://www.orphanpacific.com/upload/news_en/20220520153747MYWmMVu9fPvIu2ac.pdf/20220523_02.pdf
- https://www.chemicalbook.in/company-list/glycerol-phenylbutyrate
More… ↓
