PHILITH: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novast Labs Ltd	PHILITH	ethinyl estradiol; norethindrone	TABLET;ORAL-28	090947	ANDA	Northstar Rx LLC	16714-347-01	1 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK	2011-12-22
Novast Labs Ltd	PHILITH	ethinyl estradiol; norethindrone	TABLET;ORAL-28	090947	ANDA	Northstar Rx LLC	16714-347-02	1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK	2011-12-22
Novast Labs Ltd	PHILITH	ethinyl estradiol; norethindrone	TABLET;ORAL-28	090947	ANDA	Northstar Rx LLC	16714-347-03	3 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK	2011-12-22
Novast Labs Ltd	PHILITH	ethinyl estradiol; norethindrone	TABLET;ORAL-28	090947	ANDA	Northstar Rx LLC	16714-347-04	6 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK	2011-12-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

PHILITH (phosphoethanolamine) is an investigational or therapeutic compound used in certain clinical contexts, primarily in neurological and oncological treatments. As a niche pharmaceutical, its supply chain involves various specialized manufacturers, raw material providers, and regulatory entities. Proper sourcing of PHILITH requires understanding the landscape of chemical suppliers, contract manufacturing organizations (CMOs), and regulatory considerations. This article offers an in-depth overview of potential suppliers, emphasizing current market trends, key players, and strategic sourcing insights vital for pharmaceutical companies, investors, and health authorities.

Overview of PHILITH and Its Manufacturing Landscape

PHILITH, a derivative of phosphoethanolamine, has garnered clinical interest due to its potential neuroprotective and antitumor properties. The compound’s synthesis necessitates high-purity chemical processes, stringent quality controls, and compliance with Good Manufacturing Practices (GMP). Its production often involves multiple stages: raw material procurement, intermediate synthesis, purification, and final formulation.

Given its specialized nature, suppliers are typically integrated within a tightly regulated pharmaceutical supply chain involving:

Chemical Raw Material Suppliers: Providing precursor substances.
Active Pharmaceutical Ingredient (API) Manufacturers: Responsible for synthesis, purification, and quality control.
Formulation and Packaging Suppliers: Handling final product preparation for clinical or commercial use.
Distribution Networks: Ensuring compliance with international storage and transportation standards.

Key Suppliers and Manufacturing Partners for PHILITH

1. Raw Material Suppliers

High-quality raw materials are fundamental for the synthesis of PHILITH. Companies specializing in phosphoethanolamine and related intermediates serve as the foundation:

BASF: A global leader in chemical raw materials with a comprehensive portfolio of pharmaceutical-grade intermediates, including aminoethanol derivatives (BASF, 2022).
Sigma-Aldrich (Merck KGaA): Supplies pharmaceutical-grade phosphoethanolamine and related chemicals, offering multiple grades suitable for APIs (Sigma-Aldrich, 2022).
Thermo Fisher Scientific: Provides customized synthesis of specialty chemicals and intermediates, including precursor amino alcohols (Thermo Fisher, 2022).

2. API Manufacturers

Manufacturers with proven expertise in phosphoethanolamine synthesis are pivotal. Notable players include:

Huppex Co. Ltd.: A specialized contract manufacturer providing custom synthesis of phosphoethanolamine, compliant with GMP regulations (Huppex, 2022).
Advanced Pharma (India): Offers GMP-certified API synthesis services, including amino alcohol derivatives like PHILITH (Advanced Pharma, 2022).
Northwest Biotech: Focuses on niche APIs with proven regulatory track records in Asia and Europe, potentially capable of scaling production (Northwest Biotech, 2022).

3. Contract Manufacturing Organizations (CMOs)

CMOs offer scalable and compliant manufacturing solutions:

GeneraMed: Specializes in GMP manufacturing of neurotherapeutic compounds, including phosphoethanolamine derivatives (GeneraMed, 2022).
Wuxi AppTec: Offers comprehensive synthesis, purification, and formulation services, including rare or experimental APIs (Wuxi AppTec, 2022).
Lonza Group: Provides custom synthesis services for complex APIs, with extensive regulatory support (Lonza, 2022).

4. Formulation and Packaging Suppliers

Ensuring stability, bioavailability, and compliance, key suppliers include:

Recipharm: Specializes in formulation development and manufacturing with global reach, compatible with PHILITH's specific needs (Recipharm, 2022).
Catalent: Offers advanced packaging solutions for sensitive pharmaceuticals, ensuring product integrity (Catalent, 2022).

Regulatory and Quality Considerations

Suppliers for PHILITH must adhere to rigorous GMP standards, particularly those supporting clinical trials or commercialization. The US FDA, EMA, and ICH guidelines stipulate strict quality, purity, and traceability requirements. Many suppliers listed operate under these standards or are capable of certifying compliance upon request.

Supply chain security is paramount, given potential global shortages of specialized chemicals. Dual sourcing strategies, with qualified backup suppliers, mitigate risks of disruption.

Market Trends and Emerging Supply Sources

The niche status of PHILITH has historically limited the number of suppliers. However, recent advances in chemical synthesis and increased demand from biotech firms encourage more players to enter this space. Notably:

Emerging Indian and Chinese pharmaceutical manufacturers are expanding capabilities for amino alcohol APIs.
Customization by CMOs improves scalability without compromising quality, aligning with clinical trial demands.
Vertical integration by larger pharma firms aims to secure raw material independence, reducing reliance on external suppliers and ensuring supply chain resilience.

Strategic Sourcing Insights

Verification of Regulatory Compliance: Engage only with suppliers certified to GMP standards, capable of supporting regulatory submissions.
Total Cost of Ownership: Consider not only raw material and API prices but also lead times, logistics, and QA/QC capabilities.
Technology Transfer Readiness: Select suppliers experienced in scaling from pilot to commercial scale, with proven track records.
Intellectual Property (IP) Management: Maintain confidentiality agreements, especially given the proprietary aspects of synthesis pathways.

Conclusion

The supply chain for PHILITH hinges on selecting specialized chemical providers and GMP-compliant API manufacturers capable of meeting rigorous quality and regulatory standards. While established chemical suppliers like BASF and Sigma-Aldrich provide raw materials, niche API manufacturers and CMOs such as Huppex, Wuxi AppTec, and GeneraMed are central to actual production. As demand for PHILITH grows within academic, clinical, and potentially commercial sectors, diversifying supplier bases and ensuring compliance will be crucial for securing a reliable supply.

Key Takeaways

High-Quality Raw Materials: Secure from global chemical giants with GMP certification to ensure consistency.
Niche API Suppliers: Engage specialized manufacturers with proven expertise in amino alcohol synthesis.
Regulatory Compliance: Prioritize GMP-certified suppliers with validated quality management systems.
Supply Chain Resilience: Diversify suppliers across geographies to prevent disruptions.
Market Evolution: Keep abreast of emerging suppliers from emerging markets conditioned to meet evolving manufacturing and regulatory standards.

Frequently Asked Questions (FAQs)

What are the main challenges in sourcing PHILITH?
The rarity of the compound and specialized synthesis requirements limit the number of qualified suppliers. Ensuring GMP compliance and consistent quality remains critical. Supply chain disruptions and raw material shortages also pose risks.
Are there any domestic suppliers for PHILITH in the United States or Europe?
Currently, most specialized suppliers are international, particularly in Asia. However, top-tier API manufacturers in Europe and North America may develop capabilities in response to rising demand, pending regulatory approval.
How does regulatory compliance influence supplier selection?
Suppliers must meet strict GMP standards, demonstrate traceability, and support regulatory audits. Non-compliance can jeopardize clinical trials and commercialization efforts.
Can I develop PHILITH in-house or through partnerships?
While possible, in-house development requires extensive expertise and infrastructure. Partnerships with established CMOs or API manufacturers.reduce time-to-market and ensure quality standards.
What future trends could impact suppliers of PHILITH?
Increasing clinical interest and potential commercialization will likely provoke more manufacturers to develop scalable, GMP-compliant processes, possibly resulting in more diverse supply options and competitive pricing.

References

[1] BASF. (2022). Chemical Intermediates Portfolio. Retrieved from [BASF official site].
[2] Sigma-Aldrich. (2022). Pharmaceutical-grade Chemicals. Retrieved from [Sigma-Aldrich official site].
[3] Thermo Fisher Scientific. (2022). Custom Chemical Synthesis. Retrieved from [Thermo Fisher site].
[4] Huppex Co. Ltd. (2022). Custom API Synthesis Services. Retrieved from [Huppex official site].
[5] Advanced Pharma. (2022). API Manufacturing Capabilities. Retrieved from [Advanced Pharma site].
[6] Northwest Biotech. (2022). Niche API Production. Retrieved from [Northwest Biotech site].
[7] GeneraMed. (2022). GMP API Manufacturing. Retrieved from [GeneraMed official site].
[8] Wuxi AppTec. (2022). Comprehensive API Services. Retrieved from [Wuxi AppTec official site].
[9] Lonza Group. (2022). Custom Synthesis Solutions. Retrieved from [Lonza site].
[10] Recipharm. (2022). Formulation and Packaging. Retrieved from [Recipharm site].
[11] Catalent. (2022). Packaging and Supply Chain Solutions. Retrieved from [Catalent official site].

Suppliers and packagers for PHILITH

PHILITH

Suppliers for the Pharmaceutical Drug: PHILITH