Share This Page
Bulk Pharmaceutical API Sources for CATAPRES-TTS-2
✉ Email this page to a colleague
Bulk Pharmaceutical API Sources for CATAPRES-TTS-2
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Molport | ⤷ Get Started Free | MolPort-001-779-668 | ⤷ Get Started Free |
| AKos Consulting & Solutions | ⤷ Get Started Free | AKOS001595470 | ⤷ Get Started Free |
| AKos Consulting & Solutions | ⤷ Get Started Free | AKOS015960367 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for: CATAPRES-TTS-2
Introduction
Catapres-TTS-2 is a transdermal therapeutic system (TTS) delivering clonidine, primarily used to treat hypertension. Ensuring a reliable, high-quality source of clonidine API is crucial for manufacturers and healthcare providers to maintain consistent drug efficacy, regulatory compliance, and supply chain security. As the demand for transdermal formulations increases, sourcing clonidine API from reputable suppliers becomes paramount. This article examines key API sources for clonidine suitable for manufacturing Catapres-TTS-2, analyzing their capabilities, certifications, and market standing.
Overview of Clonidine API
Clonidine is an alpha-2 adrenergic agonist, first synthesized in the 1960s for hypertension management. Its chemical name is 5-Amino-2-[2,6-dichlorophenyl]-4,5-dihydro-1H-imidazol-2-one. The manufacturing of clonidine API requires strict adherence to Good Manufacturing Practices (GMP), with highly controlled synthesis processes to achieve high purity and stability.
The market for clonidine API is mature, with several global suppliers catering to pharmaceutical companies producing both oral and transdermal formulations, including Catapres-TTS-2.
Key Criteria for Selecting API Suppliers
When considering API sources for clonidine suitable for TTS manufacturing, several factors are essential:
- Regulatory Compliance: GMP certification, regulatory approvals (FDA, EMA, other regional agencies)
- API Purity & Quality Standards: Typically, ≥99% purity, verified via HPLC and other analytical techniques
- Supply Capacity & Reliability: Ability to meet large production demands continuously
- Manufacturing Location & Control: Prefer suppliers with integrated quality management systems and transparent supply chains
- Cost-effectiveness: Competitive pricing without sacrificing quality
Top API Suppliers for Clonidine (for Catapres-TTS-2)
1. BioReperia AB
A Swedish CDMO specializing in custom synthesis of APIs with an emphasis on cardiovascular and CNS drugs. BioReperia offers clonidine APIs produced under cGMP conditions, with extensive analytical characterization. Their facilities are certified by EMA and comply with US FDA standards, aligning well with multinational requirements.
- Strengths: Proven track record with high-quality clonidine batches, flexible supply chain, and analytical transparency.
- Certifications: GMP, ISO 9001, ISO 17025 (analytical labs).
2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A leading Chinese pharmaceutical manufacturer, Huahai provides clonidine with a focus on high-volume production and cost competitiveness. Their clonidine API is widely used globally, backed by rigorous quality controls compliant with both Chinese and international standards.
- Strengths: Large-scale manufacturing, competitive pricing, consistent quality.
- Certifications: GMP, ISO 9001, and compliance with US FDA and EMA regulations.
3. Sandoz (Novartis division)
A global leader in generics and biosimilars, Sandoz produces clonidine API for internal use and external sale to high-end clients. Their manufacturing facilities in Europe are FDA- and EMA-certified, ensuring compliance with the strictest quality standards.
- Strengths: High-quality API, extensive regulatory support, robust supply chain.
- Certifications: GMP, ISO certifications, and global regulatory approvals.
4. Zhejiang Hisun Pharmaceutical Co., Ltd.
Another key Chinese API manufacturer, Hisun supplies clonidine globally. Their facilities maintain high GMP standards, and their API meets international pharmacopoeias' specifications. Hisun offers scalable solutions, essential for TTS product manufacturing.
- Strengths: Cost-effective, reliable, high-volume capacity.
- Certifications: GMP, ISO 9001, and compliance with U.S. and European regulations.
5. Zhejiang Tianyu pharma
Specialized in CNS API production, Tianyu offers clonidine synthesized under GMP conditions with an emphasis on purity and stability—key parameters for TTS formulations. Their products undergo rigorous testing for residual solvents, heavy metals, and batch-to-batch consistency.
- Strengths: Focused development expertise, customized quality parameters.
- Certifications: GMP, ISO compliance, and regional regulatory recognitions.
Third-Party API Distributors
Beyond direct manufacturers, several reputable API distributors facilitate sourcing clonidine from multiple manufacturers, ensuring flexibility in supply chains:
- API laboratories (e.g., Cambrex, Thermo Fisher Scientific) provide a range of clonidine APIs sourced from verified manufacturers with documented GMP compliance.
- Authorized vendors with extensive documentation offer Certificates of Analysis (CoA), stability data, and regulatory support.
Regulatory & Quality Considerations
Supply chain sustainability and regulatory compliance are non-negotiable. Manufacturers procuring clonidine API should verify:
- GMP certification validity
- Batch documentation: CoA, analytical data, stability reports
- Traceability: Full supply chain visibility from raw materials to finished API
- Product stability: Stability testing under various storage conditions, ensuring API integrity for TTS fabrication (which involves prolonged storage and specific formulation requirements).
International standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) provide benchmark specifications for clonidine API, serving as essential quality references for procurement.
Global Market Dynamics and Sourcing Trends
The market for clonidine API is characterized by its mature production capabilities in China and India, combined with high-quality European and North American suppliers. The combination of cost competitiveness and regulatory robustness influences strategic sourcing decisions, which are crucial for the stable manufacturing of Catapres-TTS-2.
Emerging trends include pre-qualification by regulatory agencies and long-term supply agreements to ensure continuous availability. The proliferation of regional regulatory frameworks necessitates corroborating supplier certifications and audit-ready documents.
Conclusion
Reliable sourcing of clonidine API for Catapres-TTS-2 hinges on differentiating suppliers through compliance, quality, capacity, and cost. Top-tier manufacturers like BioReperia, Zhejiang Huahai, Sandoz, and Hisun offer a robust foundation for pharmaceutical companies to manufacture high-quality transdermal clonidine products. Engaging with verified distributors and conducting thorough due diligence are essential to ensuring supply chain integrity and maintaining regulatory standards.
Key Takeaways
- High-quality clonidine API is critical for manufacturing effective Catapres-TTS-2 transdermal formulations.
- Leading API providers include BioReperia, Zhejiang Huahai, Sandoz, Hisun, and Tianyu, each with distinct strengths in quality and capacity.
- Regulatory compliance, such as GMP certification and adherence to pharmacopoeial standards, remains a priority in supplier selection.
- Establishing long-term supply agreements with verified vendors minimizes risks of shortages or quality discrepancies.
- Conducting comprehensive audits and verifying certifications should precede procurement to align with global regulatory expectations.
FAQs
1. What are the key quality parameters to evaluate when sourcing clonidine API for TTS products?
Primarily, purity (≥99%), residual solvent levels, heavy metals, stability profile, and batch-to-batch consistency. Analytical data from reputable laboratories should support these quality parameters.
2. Is Chinese manufactured clonidine API compliant with U.S. and European regulations?
Many Chinese manufacturers, such as Zhejiang Huahai and Hisun, hold GMP certifications recognized by agencies like the FDA and EMA, making their APIs suitable for international markets when properly validated.
3. Can I source clonidine API directly from chemical suppliers or API specialty companies?
Yes; reputable API manufacturers offer direct supply, often providing extensive documentation and regulatory support required for pharmaceutical manufacturing.
4. How does the choice of API source affect Catapres-TTS-2 manufacturing costs?
Cost is influenced by the manufacturer’s location, scale, and regulatory overhead. While Chinese APIs are generally more economical, European suppliers may offer higher assurance of compliance, potentially reducing regulatory hurdles.
5. What steps should be taken to qualify a new clonidine API supplier?
Conduct supplier audits, verify GMP certification, review analytical and stability data, assess supply capacity, and obtain samples for in-house testing before long-term procurement agreements.
Sources:
[1] U.S. Pharmacopeia (USP) – Clonidine specifications
[2] European Pharmacopoeia (EP) – Clonidine monograph
[3] Sandoz corporate website – API manufacturing standards
[4] Zhejiang Huahai official publications – API production overview
[5] Regulatory agencies’ inspection reports and supplier certifications
More… ↓
