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Suppliers and packagers for generic pharmaceutical drug: CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
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CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mainpointe | TUXARIN ER | chlorpheniramine maleate; codeine phosphate | TABLET, EXTENDED RELEASE;ORAL | 206323 | NDA | Mainpointe Pharmaceuticals | 71269-040-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10) | 2018-10-15 |
| Mainpointe | TUXARIN ER | chlorpheniramine maleate; codeine phosphate | TABLET, EXTENDED RELEASE;ORAL | 206323 | NDA | Mainpointe Pharmaceuticals | 71269-040-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30) | 2018-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Chlorpheniramine Maleate and Codeine Phosphate
Introduction
In the global pharmaceutical landscape, sourcing high-quality active pharmaceutical ingredients (APIs) is critical for manufacturers, healthcare providers, and regulatory bodies. This report focuses on suppliers for two commonly used medications: chlorpheniramine maleate and codeine phosphate. Both compounds are integral in respiratory and analgesic therapies, respectively, and their sourcing influences drug efficacy, safety, and regulatory compliance.
Understanding the supplier landscape enables stakeholders to ensure product consistency, cost-effectiveness, and compliance with international standards. This report offers a comprehensive overview of key manufacturers, their manufacturing capacities, geopolitical considerations, and supply chain dynamics for chlorpheniramine maleate and codeine phosphate.
Overview of Chlorpheniramine Maleate and Codeine Phosphate
Chlorpheniramine Maleate
Chlorpheniramine maleate is an antihistaminic agent used to alleviate allergy symptoms. It is part of the first-generation antihistamines classified under H1 receptor antagonists. Its widespread use demands reliable suppliers to meet global demand while maintaining stringent quality standards.
Codeine Phosphate
Codeine phosphate is an opiate analgesic and antitussive used for mild to moderate pain and cough suppression. Given its classification as a controlled substance, sourcing is regulated, with suppliers required to comply with international drug control laws (e.g., UN Single Convention on Narcotic Drugs).
Major Suppliers for Chlorpheniramine Maleate
1. Sun Pharmaceutical Industries Ltd.
Overview: An Indian multinational, Sun Pharma manufactures a broad range of APIs, including chlorpheniramine maleate. Their facilities adhere to Good Manufacturing Practices (GMP) and meet USFDA and EMA standards.
Strengths: Extensive global distribution network and robust quality management systems make Sun Pharma a preferred supplier for generic versions.
2. Macleods Pharmaceuticals
Overview: Based in India, Macleods offers high-quality chlorpheniramine maleate with consistent batch-to-batch quality. They invest heavily in R&D to optimize synthesis processes.
Strengths: Competitive pricing and reliable supply chain make Macleods a key player in Asian and emerging markets.
3. Zhejiang Medicine Co., Ltd.
Overview: A leading Chinese API manufacturer, Zhejiang Medicine supplies chlorpheniramine maleate to both domestic and international markets.
Strengths: Advanced manufacturing facilities and compliance with Chinese GMP standards enable Zhejiang to serve large-scale demand efficiently.
4. S.C. Johnson & Son, Inc. (now part of Johnson & Johnson)
Although primarily known for consumer products, Johnson & Johnson’s pharmaceutical division supplies APIs like chlorpheniramine maleate in certain formulations. Their global compliance and quality assurance are notable.
5. Other Notable Suppliers
- Aarti Drugs Ltd. (India)
- Cayman Chemical Company (USA)
- Danish Pharmacological Company (Denmark)
Leading Suppliers for Codeine Phosphate
1. Sinopharm Group Co., Ltd.
Overview: As China's leading pharmaceutical importer and manufacturer, Sinopharm supplies codeine phosphate complying with Chinese GMP and regulatory standards.
Strengths: Concentrated on high-quality APIs with integrated supply chains and strict quality control.
2. Boehringer Ingelheim
Overview: A German pharmaceutical giant, Boehringer Ingelheim produces codeine phosphate for pharmaceutical use, adhering to stringent European and US standards.
Strengths: Renowned for quality, regulatory compliance, and sustained R&D investments.
3. Mallinckrodt Pharmaceuticals
Overview: An established global supplier, Mallinckrodt sources and supplies controlled substance APIs, including codeine phosphate, primarily for North American markets.
Strengths: Extensive experience with controlled substances regulation and supply chain reliability.
4. Gujarat State Fertilizers & Chemicals Limited (India)
Overview: This government-owned enterprise manufactures various APIs, including controlled substances like codeine phosphate, fulfilling domestic and export contracts.
Strengths: Strong regulatory compliance framework and competitive pricing.
5. AKZO Nobel
While mainly recognized for chemicals, parts of their portfolio include pharmaceutical-grade codeine derivatives supplied through licensed manufacturers.
Regulatory and Legal Considerations
Given that both chlorpheniramine maleate and codeine phosphate are subject to regulation, sourcing involves adherence to:
- Good Manufacturing Practices (GMP): Ensures APIs meet quality standards.
- Controlled Substance Regulations: Codeine is classified as a narcotic, requiring licenses, secure handling, and compliance with international treaties (e.g., UN Single Convention).
- Import/Export Restrictions: Countries impose restrictions affecting supply chains, especially for controlled substances like codeine.
Manufacturers and distributors must navigate these regulatory frameworks diligently to maintain legal compliance and supply chain integrity.
Supply Chain Dynamics and Challenges
- Geopolitical Factors: Trade disputes, sanctions, and political stability influence supplier reliability, especially with Chinese and Indian API producers.
- Quality Consistency: Differing GMP standards worldwide necessitate rigorous supplier qualification processes.
- Raw Material Availability: Fluctuations in precursor chemical availability impact production capacity.
- Regulatory Changes: Evolving laws on controlled substances can restrict or complicate sourcing, requiring proactive compliance strategies.
Emerging Trends in API Sourcing
- Localization and Diversification: To mitigate geopolitical risks, companies diversify supplier bases geographically.
- Vertical Integration: Some pharmaceutical companies seek in-house API manufacturing to control quality and supply.
- Digital Supply Chain Management: Enhanced traceability and real-time monitoring improve procurement efficiency.
Conclusion
The sourcing of chlorpheniramine maleate and codeine phosphate involves navigating a complex network of global suppliers, regulatory landscapes, and quality requirements. Leading manufacturers like Sun Pharma, Macleods, Sinopharm, and Boehringer Ingelheim provide reliable APIs, but supply stability depends heavily on geopolitical and regulatory factors. Ensuring supplier qualification, compliance, and supply chain resilience remains paramount for organizations relying on these APIs for vital therapeutic applications.
Key Takeaways
- Global Supplier Diversity is critical for ensuring uninterrupted supply and mitigating geopolitical risks.
- Rigorous Quality Control and Regulatory Compliance are mandatory, especially for controlled substances like codeine phosphate.
- Strategic Partnerships with Reputable Manufacturers such as Sun Pharma, Boehringer Ingelheim, and Sinopharm bolster supply chain security.
- Monitoring Regulatory Changes in drug control laws and import restrictions is essential for compliance and planning.
- Investing in Supply Chain Transparency and Digital Tracking enhances product traceability and operational resilience.
Frequently Asked Questions
1. Are there alternatives to major suppliers for chlorpheniramine maleate and codeine phosphate?
Yes, several regional manufacturers produce these APIs, providing alternative sourcing options. However, quality and regulatory compliance must be carefully verified.
2. How do regulatory restrictions impact the global supply of codeine phosphate?
Since codeine is a controlled substance, regulations often restrict manufacturing, import, and export. This can lead to supply shortages or delays, especially if licensing or compliance issues arise.
3. What are the key qualities to consider when qualifying an API supplier?
Regulatory compliance (GMP certification), quality assurance protocols, manufacturing capacity, supply stability, and adherence to international standards are crucial criteria.
4. How does geopolitical tension influence API availability?
Trade restrictions, sanctions, and political conflicts can disrupt supply chains, leading to shortages or increased procurement costs from certain regions.
5. What future developments could impact API sourcing for these drugs?
Advancements in synthesis technology, increased regulatory scrutiny, post-pandemic supply chain restructuring, and shifts toward localized manufacturing are shaping future sourcing strategies.
References:
- [1] US Food and Drug Administration (FDA). “Active Pharmaceutical Ingredient (API) Manufacturing.” FDA.gov, 2022.
- [2] World Health Organization. "Guidelines on the Regulatory Control of Drugs," WHO Technical Report Series, 2015.
- [3] International Narcotics Control Board. "Report for 2022," INCB.org.
- [4] European Medicines Agency. "Good Manufacturing Practice (GMP) guide," EMA.europa.eu.
- [5] Pharmaceutical Technology. "Top API Manufacturers," PharmaTechnology.com, 2023.
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