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Suppliers and packagers for generic pharmaceutical drug: CAPSAICIN
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CAPSAICIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395 | NDA | Averitas Pharma Inc | 72512-928-01 | 1 KIT in 1 CARTON (72512-928-01) * 1 POUCH in 1 CARTON (72512-920-00) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | 2018-10-30 |
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395 | NDA | Averitas Pharma Inc | 72512-929-01 | 1 KIT in 1 CARTON (72512-929-01) * 2 POUCH in 1 CARTON (72512-920-01) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE | 2018-10-30 |
| Averitas | QUTENZA | capsaicin | PATCH;TOPICAL | 022395 | NDA | Averitas Pharma Inc | 72512-930-01 | 1 KIT in 1 CARTON (72512-930-01) * 4 POUCH in 1 CARTON (72512-920-02) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 3 TUBE in 1 CARTON / 50 g in 1 TUBE | 2021-03-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Capsaicin
Introduction
Capsaicin, a bioactive compound extracted predominantly from chili peppers, has a well-documented role in pharmacology and the pharmaceutical industry. Its applications span analgesic formulations, topical preparations, and potential therapeutic agents for conditions such as neuropathic pain, arthritis, and metabolic disorders. As demand for capsaicin-based pharmaceuticals grows, identifying reliable suppliers capable of providing high-quality, pharmaceutical-grade capsaicin becomes crucial for pharmaceutical manufacturers, research institutions, and other stakeholders.
Overview of Capsaicin in the Pharmaceutical Industry
Capsaicin’s therapeutic potential derives from its ability to interact with transient receptor potential vanilloid 1 (TRPV1) receptors, modulating pain signals. It is primarily supplied as a raw extract, purified compound, or as an active pharmaceutical ingredient (API) with stringent purity standards required by regulatory agencies such as the FDA and EMA. Suppliers capable of meeting these specifications tend to be established chemical and botanical extract manufacturers with extensive capabilities in extraction, purification, and quality assurance.
Key Attributes of Pharmaceutical-Grade Capsaicin
- Purity Standards: Typically exceeding 98% purity, with compliance to pharmacopeial standards such as USP, European Pharmacopoeia (EP), or Chinese Pharmacopoeia (ChP).
- Source Material Quality: High-grade chili isolates or synthetic capsaicin must meet botanical and agricultural quality benchmarks.
- Manufacturing Certifications: Good Manufacturing Practice (GMP) certification ensures consistent quality, safety, and regulatory compliance.
- Supply Chain Reliability: Capable of large-volume supply, stable delivery timelines, and adherence to regulatory requirements.
Leading Capsaicin Suppliers for Pharmaceuticals
1. Indofine Chemical Company
Overview: With over 90 years of experience, Indofine specializes in supplying high-purity chemicals for research and pharmaceutical applications. Their capsaicin is available in various purities suitable for pharmaceutical formulations.
Key Features:
- USP-grade capsaicin.
- Extensive analytical data for purity confirmation.
- GMP manufacturing capabilities.
Relevant Applications: Pharmaceutical research, formulation development, and clinical trials.
2. Hangzhou Aoda Pharmaceutical Co., Ltd.
Overview: Based in China, Aoda Pharmaceutical is a prominent manufacturer of botanical extracts, including capsaicin, with strict adherence to pharmaceutical standards.
Key Features:
- GMP-approved facilities.
- Capable of producing large batches of high-purity capsaicin.
- Certification compliance (ISO, GMP).
Relevance: Supplying pharmaceutical companies in Asia, Europe, and North America.
3. Zhejiang Skyherb Bio-tech Co., Ltd.
Overview: A specialized botanical extract producer with dedicated manufacturing of capsaicin for pharmaceutical markets.
Key Features:
- Purity levels exceeding 98%.
- Comprehensive quality control testing.
- Regulatory approval for global distribution.
Application: Dietary supplements, topical formulations, and research chemicals.
4. Tocris Bioscience (A part of Bio-Techne Corporation)
Overview: A globally recognized supplier of biochemical reagents, Tocris offers pharmaceutical-grade capsaicin designed for research and preclinical applications.
Key Features:
- High purity (≥99%).
- Certified GMP status.
- Reliable supply chain.
Relevance: Primarily serving research institutions and pharmaceutical R&D.
5. Sigma-Aldrich (Part of Merck KGaA)
Overview: As a global leader in chemical and biochemical supplies, Sigma-Aldrich provides pharmaceutical-grade capsaicin suitable for research and formulation.
Key Features:
- Compliant with pharmacopeial standards.
- Extensive analytical documentation.
- Global distribution network.
Use Cases: Pharmacological research, formulation, and preclinical studies.
Emerging Suppliers and Synthetic Alternatives
While natural extraction remains predominant, advances in synthetic chemistry now enable chemical synthesis of capsaicin, offering potential benefits such as scale-up flexibility, batch consistency, and reduced contamination risks. Companies engaged in organic synthesis may serve pharmaceutical needs, especially where high-volume or specialized derivatives are required.
Synthetic suppliers:
- TCI America and similar companies offer synthetic capsaicin with high purity for research and pharmaceutical applications.
Note: Regulatory acceptance of synthetic forms varies and depends on regional approval pathways.
Regulatory and Quality Considerations
Pharmaceutical suppliers must comply with strict quality standards, including:
- GMP Certification: Ensures manufacturing processes meet quality criteria.
- Regulatory Documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and compliance certificates.
- Batch Consistency: Critical for reproducibility in pharmaceutical applications.
Verification of supplier credentials via audits, third-party testing, and regulatory audits helps mitigate risks related to contamination, variability, or non-compliance.
Supply Chain Dynamics and Market Trends
The global capsaicin market is influenced by factors such as:
- Rising demand for analgesic formulations.
- Increased interest in natural product therapeutics.
- Challenges in supply chain stability due to geopolitical and agricultural variability.
Major suppliers focusing on quality assurance and scalability are well-positioned to capitalize on these trends. Additionally, synthetic manufacturing offers an alternative route amid volatile agricultural markets.
Conclusion
The selection of suppliers for pharmaceutical-grade capsaicin demands meticulous evaluation of quality, regulatory adherence, supply stability, and compliance. Leading players such as Indofine, Hangzhou Aoda, Zhejiang Skyherb, Tocris, and Sigma-Aldrich have established reputations for providing high-quality capsaicin suitable for pharmaceutical formulations and research. As the market evolves, synthetic routes and emerging botanical suppliers are broadening options, supporting increased demand and innovation.
Key Takeaways
- Focus on suppliers with GMP certification, high purity standards (>98%), and regulatory compliance.
- Natural extraction remains dominant, but synthetic capsaicin is emerging as a scalable alternative.
- Supply chain stability and certification enable pharmaceutical companies to mitigate risks.
- Due diligence involving audits, regulatory validation, and analytical testing is essential when selecting suppliers.
- The growing demand for capsaicin in pharmaceutical and research applications underscores the importance of diversified sourcing strategies.
FAQs
1. What are the primary sources of pharmaceutical-grade capsaicin?
Capsaicin is mainly extracted from chili peppers, particularly species like Capsicum annuum and Capsicum frutescens. Synthetic capsaicin is also produced via organic synthetic pathways, offering consistent quality and supply.
2. How do I verify the quality of capsaicin from suppliers?
Request Certificates of Analysis, review pharmacopoeial compliance documentation, and conduct independent analytical testing to confirm purity, potency, and absence of contaminants.
3. Are synthetic capsaicin products acceptable for pharmaceutical use?
Yes, synthetic capsaicin can be acceptable if it meets pharmacopeial standards and regulatory requirements. Regulatory agencies evaluate synthetic versus natural sources on a case-by-case basis.
4. Which certifications should I look for in a capsaicin supplier?
GMP certification, ISO certifications, and compliance with pharmacopeial standards (USP, EP) are essential indicators of quality for pharmaceutical-grade capsaicin.
5. What recent market trends influence supplier selection?
Growing demand for natural analgesics, regulatory emphasis on product purity, and advances in synthetic manufacturing influence supplier choice, emphasizing quality assurance and reliable supply chains.
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