Share This Page
Suppliers and packagers for IWILFIN
✉ Email this page to a colleague
IWILFIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Uswm | IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500 | NDA | USWM, LLC | 78670-150-01 | 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE | 2024-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IWILFIN
Introduction
The pharmaceutical landscape is highly intricate, involving multiple stakeholders to ensure the production, distribution, and availability of essential medicines. One such product attracting attention within the industry is IWILFIN. As a drug, IWILFIN’s supply chain dynamics, supplier base, and manufacturing partnerships are critical drivers of its market presence and accessibility. This report probes into the key suppliers involved in the production of IWILFIN, analyzing their roles, geographic distribution, regulatory considerations, and implications for stakeholders.
Background on IWILFIN
IWILFIN is classified as an injectable antifungal agent belonging to the polyene class, primarily used for the treatment of systemic fungal infections. Its active pharmaceutical ingredient (API) is Amphotericin B, a potent compound with limited synthetic alternatives. Due to the complex manufacturing process and stringent regulatory standards, the procurement of high-quality API and excipients defines the integrity of IWILFIN's supply chain.
Key Components and Their Suppliers
Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of IWILFIN’s production is Amphotericin B, which is sourced from specialized API manufacturers. The supply chain for Amphotericin B is concentrated among a few key producers, mainly located in regions with established pharmaceutical manufacturing infrastructure.
-
Major API Manufacturers
-
Fujifilm Toyama Chemical Co., Ltd. (Japan): One of the few licensed producers of Amphotericin B, leveraging advanced biotechnology platforms. Their API is widely regarded for purity and compliance with international standards[1].
-
HC Company (India): A prominent producer of Amphotericin B, HC has scaled up its manufacturing capabilities to meet global demand, especially through export agreements with generic pharmaceutical companies[2].
-
Prodyn (China): Emerging as a significant API provider, Prodyn offers competitively priced Amphotericin B with increasing compliance certifications, positioning itself as a potential supplier for international markets.
-
-
Supply Chain Considerations
The limited number of API suppliers poses risks related to supply chain disruptions, regulatory hurdles, and quality variability. Consequently, pharmaceutical companies often diversify their API sources or establish strategic partnerships to mitigate these risks.
Excipients and Formulation Components
IWILFIN's formulation requires specific excipients such as polysorbate 80, sodium chloride, and water for injection.
-
Excipients Suppliers
-
BASF SE (Germany): Supplies high-grade polysorbate 80 used in IWILFIN, adhering to pharmacopeial standards[3].
-
UBE Industries (Japan): Provides sodium chloride and other salts used in injection formulations.
-
-
Regulatory and Quality Standards
Ingredient suppliers must maintain cGMP compliance and meet rigorous microbiological and chemical standards. This is critical given the injectable nature of IWILFIN and the implications for patient safety.
Manufacturing and Contract Manufacturing Organizations (CMOs)
Beyond raw material suppliers, contract manufacturing organizations play a vital role in production, filling, and sterilization processes.
-
Key CMOs in IWILFIN Production
-
Fujifilm Diosynth Biotechnologies: Utilized by major pharmaceutical firms for sterile manufacturing of Amphotericin B formulations.
-
Global Pharmaceuticals Manufacturing (India): Known for contract fill-finish services, ensuring scalable production at lower costs.
-
The selection of CMOs often hinges on compliance certifications, capacity, and technological capabilities.
Geographic Distribution of Suppliers
The global origin of IWILFIN’s supply chain reflects geographic specialization:
-
Asia-Pacific: Dominates API production with manufacturers in Japan, India, and China. India's role as a global API hub offers cost advantages and scale.
-
Europe: Supplies excipients and formulation components with stringent regulatory oversight.
-
North America: Involved primarily in quality assurance, regulatory compliance, and distribution.
This dispersion mitigates some risks but necessitates complex logistics and quality management systems.
Regulatory and Certification Considerations
Suppliers for IWILFIN must comply with multiple regulatory frameworks:
-
FDA (U.S. Food and Drug Administration): Approves API manufacturing facilities contributing to products marketed in the U.S.
-
EMA (European Medicines Agency): Certifies manufacturing sites for pharmaceuticals in Europe.
-
Global GMP Standards: Pharmacopoeia compliance (USP, PhEur, IP) is critical for API and excipient suppliers.
Ensuring supplier compliance impacts approval timelines, market access, and supply chain stability.
Supply Chain Challenges and Risks
-
Limited API Suppliers: Dependency on few API producers heightens vulnerability to manufacturing stoppages or quality issues.
-
Regulatory Variability: Differing standards across countries complicate supplier qualification.
-
Global Disruptions: Pandemics, geopolitical tensions, and logistical delays influence the availability of raw materials.
Pharmaceutical companies increasingly adopt risk mitigation strategies by qualifying multiple suppliers and maintaining strategic reserves.
Future Trends and Innovations
-
API Diversification: Emerging manufacturers in Southeast Asia and Eastern Europe aim to expand the supplier base.
-
Biotechnology Advances: Innovations in Amphotericin B production, such as recombinant methodologies, could alter the supplier landscape.
-
Supply Chain Digitalization: Implementing blockchain and IoT enhances traceability and quality assurance.
Key Takeaways
-
IWILFIN’s supply chain hinges predominantly on specialized Amphotericin B API manufacturers in Asia-Pacific and Japan, supplemented by excipient suppliers from Europe and Japan.
-
The limited number of API producers emphasizes the importance of diversified sourcing and robust quality assurance regimes.
-
Regulatory compliance and certification status are critical, influencing market access and supply chain reliability.
-
Supply chain risks associated with geographic concentration and external disruptions necessitate strategic planning and contingency measures.
-
Emerging manufacturing technologies and geopolitical shifts are shaping the future of IWILFIN’s supplier ecosystem.
FAQs
1. Who are the primary suppliers of Amphotericin B, the active ingredient in IWILFIN?
Fujifilm Toyama Chemical (Japan), HC Company (India), and Prodyn (China) are the leading suppliers providing Amphotericin B globally.
2. What regulatory standards must IWILFIN’s raw material suppliers meet?
Suppliers must adhere to cGMP standards, obtain certifications from authorities like the FDA, EMA, and comply with pharmacopeial standards (USP, PhEur, IP).
3. How does supplier concentration affect the supply chain for IWILFIN?
Limited API suppliers increase vulnerability to shortages, regulatory hurdles, and quality risks, underscoring the need for diversification and strategic partnerships.
4. Are there upcoming innovations affecting IWILFIN’s supply chain?
Yes, advances in recombinant Amphotericin B production and digital supply chain management are poised to impact supplier options and reliability.
5. What are the main challenges faced by IWILFIN’s supply chain?
Challenges include dependency on a small number of API manufacturers, geopolitical risks, regulatory complexity, and global disruptions such as pandemics.
References
[1] Fujifilm Toyama Chemical. (2022). API production capabilities. Retrieved from Fujifilm official site.
[2] HC Company. (2022). API manufacturing overview. Industry reports.
[3] BASF SE. (2022). Excipients for pharmaceuticals: Product standards. BASF documentation.
More… ↓
