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Suppliers and packagers for ADCIRCA
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ADCIRCA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332 | NDA | United Therapeutics Corporation | 66302-467-60 | 60 TABLET in 1 BOTTLE (66302-467-60) | 2009-05-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ADCIRCA
Introduction
ADCIRCA, the brand name for tadalafil, is a widely prescribed medication primarily used to treat pulmonary arterial hypertension (PAH) and erectile dysfunction (ED). As a complex small-molecule therapeutic, ADCIRCA's supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation producers, and distribution channels. Understanding the saturation, geographic distribution, and strategic roles of suppliers is critical for pharmaceutical companies, healthcare providers, and investors seeking supply stability, cost competitiveness, and regulatory compliance.
Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of ADCIRCA’s supply hinges on the procurement of high-quality tadalafil API. API manufacturing is geographically concentrated, with prominent regions including China, India, and to a lesser extent, European countries.
Chinese API Manufacturers
China is a dominant supplier of tadalafil API due to its robust chemical manufacturing infrastructure and cost advantages. Notable Chinese API producers include:
- North China Pharmaceutical Group (NCPC): Engaged in generic API production, including tadalafil.
- Shandong Topscience Inc.: Known for complex chemical synthesis and supplying tadalafil API to global markets [1].
- Qilu Pharmaceutical: Active in API manufacturing, with capabilities extending to cardiovascular agents.
Chinese API suppliers often provide competitive pricing but may face regulatory challenges regarding quality assurance and compliance with international standards like cGMP (current Good Manufacturing Practice).
Indian API Manufacturers
India houses numerous APIs manufacturers recognized for high-quality output and adherence to international standards. Leading Indian API firms supplying tadalafil include:
- Sun Pharmaceutical Industries Ltd.: A major producer with extensive API facilities, regularly exporting to global markets.
- Lupin Limited: Known for generics and active ingredients, including tadalafil API [2].
- Cipla Limited: Engaged in API manufacturing, with a focus on quality and scalable production.
India's API industry benefits from stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) and certification processes aligned with U.S. FDA and EMA standards, facilitating global distribution.
European API Manufacturers
European firms are fewer but focus on high-quality, specialty API production. Companies such as:
- Evonik Industries (Germany): Specialized in advanced chemical manufacturing, including pharmaceuticals.
- Recipharm (Sweden): Contract development and manufacturing organization (CDMO) with capabilities for active ingredient production.
European suppliers primarily serve markets where regulatory standards require compliance with stringent quality norms.
Formulation and Finished Dosage Product Suppliers
Besides API producers, manufacturing of finished ADCIRCA tablets involves formulation expertise, quality control, and packaging.
- Pfizer Inc.: The original developer and marketer of ADCIRCA, maintaining manufacturing facilities for finished product distribution worldwide.
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Contract Manufacturing Organizations (CMOs): Several CDMOs globally are involved in formulation, packaging, and distribution, including:
- Alvotech (Iceland): Contract manufacturing organization providing formulation services.
- Catalent: A prominent CDMO specializing in oral solid dosage forms, including tadalafil.
These organizations ensure compliance with pharmacopeial standards and facilitate rapid scalability for high-demand markets.
Distribution and Logistics Providers
The global supply chain relies on logistics companies that handle storage, transportation, and distribution:
- DHL, FedEx, and UPS: Ensure timely delivery of active ingredients and finished products.
- Cold Chain Logistics: Necessary for sensitive pharmaceutical ingredients, particularly during international shipping.
The distribution network must adapt to regional regulations, geopolitical challenges, and pandemic-related disruptions, emphasizing the importance of diversified supplier and logistics partnerships.
Strategic Considerations in ADCIRCA Supplier Selection
The sourcing of ADCIRCA involves balancing cost, quality, regulatory compliance, and supply chain stability. Pharmaceutical companies often adopt multi-source strategies to mitigate risks associated with supplier dependency, geopolitical issues, and manufacturing disruptions.
- Regulatory Certification: Suppliers must possess relevant certifications such as cGMP compliance, ISO standards, and validation reports.
- Quality Assurance: Rigorous testing and consistent batch quality are non-negotiable to meet global standards.
- Supply Continuity: Long-term agreements and diversified sourcing reduce supply risks.
Regulatory and Quality Implications
Suppliers must align with international regulatory frameworks to facilitate market access, including adherence to FDA, EMA, and other global agencies’ standards. The quality of tadalafil APIs, in particular, determines the safety and efficacy profile of ADCIRCA.
- Inspection & Audits: Regular audits are mandatory for manufacturers to maintain certification.
- Traceability: Comprehensive documentation ensures transparency in the supply chain, crucial during recalls or adverse event investigations.
Conclusion
The procurement landscape for ADCIRCA involves a complex web of high-quality API manufacturers primarily situated in China and India, with European firms contributing specialty API production. Finished dosage manufacturing is often handled through strategically selected CMOs, with distribution facilitated by global logistics providers. Maintaining a resilient, compliant, and cost-effective supply chain necessitates ongoing supplier evaluation, regulatory vigilance, and diversification.
Key Takeaways
- Diverse sourcing: Reliance on multiple API suppliers from China and India enhances resilience.
- Regulatory compliance: Certifications like cGMP are critical for global distribution.
- Quality focused: Peer-reviewed quality assurance processes safeguard therapeutic integrity.
- Supply chain agility: Diversifying suppliers and logistics partners mitigates risks.
- Strategic partnerships: Long-term vendor relationships secure stability amid market fluctuations.
FAQs
-
Who are the leading API suppliers for ADCIRCA globally?
Chinese and Indian manufacturers dominate the tadalafil API supply chain, with notable Chinese firms like Shandong Topscience and Indian firms such as Sun Pharma being key players. -
What quality standards are essential for tadalafil API suppliers?
Suppliers must comply with cGMP, ISO certifications, and demonstrate adherence to regulatory requirements from agencies like the FDA and EMA. -
How does supplier diversification benefit ADCIRCA manufacturing?
It reduces dependency on single sources, minimizes risks of supply disruption, and ensures compliance with international standards. -
Are there any European manufacturers of tadalafil API?
European firms are fewer but include companies like Evonik Industries, focusing on specialty and high-quality APIs to serve regulated markets. -
What role do CMOs play in ADCIRCA’s supply chain?
CMOs handle formulation, packaging, and distribution, enabling manufacturers to scale production efficiently and meet regional demand.
References
[1] Shandong Topscience Inc. Product Portfolio. (2022).
[2] Lupin Limited Annual Report. (2022).
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