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Suppliers and packagers for generic pharmaceutical drug: chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
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chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | ADVIL ALLERGY SINUS | chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 021441 | NDA | Haleon US Holdings LLC | 0573-0188-10 | 20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK | 2002-12-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Chlorpheniramine Maleate, Ibuprofen, and Pseudoephedrine Hydrochloride
Introduction
Navigating the pharmaceutical supply chain for active pharmaceutical ingredients (APIs) such as Chlorpheniramine Maleate, Ibuprofen, and Pseudoephedrine Hydrochloride requires a comprehensive understanding of global suppliers, regulatory considerations, and market dynamics. Ensuring consistent quality, regulatory compliance, and cost competitiveness is vital for pharmaceutical companies, generic drug manufacturers, and distributors. This analysis provides an in-depth overview of leading suppliers for these APIs, highlighting market trends, sourcing strategies, and key factors influencing procurement decisions.
Chlorpheniramine Maleate Suppliers
Overview
Chlorpheniramine Maleate is a widely used antihistamine primarily indicated for allergy relief. The global market for Chlorpheniramine has experienced steady demand, driven by over-the-counter (OTC) formulations and combination cold and allergy medications.
Major Suppliers and Manufacturing Hubs
1. India
India remains the dominant supplier of Chlorpheniramine Maleate, accounting for over 50% of global exports. Indian pharmaceutical companies such as Sun Pharmaceutical Industries, Lupin Limited, and Aurobindo Pharma manufacture high-quality APIs, supported by robust facilities compliant with Good Manufacturing Practices (GMP) ([1]).
2. China
China supplies a significant share of the global Chlorpheniramine API, with manufacturers like Hunan Warrant Pharmaceutical Co., Jiangxi Xian Yaogao Co., and Qingdao Sinomed Pharmaceutical Co. offering competitive pricing and large-scale production capabilities ([2]).
3. Other Regions
- Europe and North America primarily import from Indian and Chinese producers, with a smaller number of regional producers maintaining GMP standards for specialty markets.
Regulatory Considerations
Suppliers operating in India and China have successfully obtained certifications from the World Health Organization (WHO), US Food and Drug Administration (FDA), and European Medicines Agency (EMA). Ensuring supplier compliance with these standards is crucial for market access.
Ibuprofen Suppliers
Overview
Ibuprofen is among the most widely used nonsteroidal anti-inflammatory drugs (NSAIDs). The global demand is driven by both OTC and prescription markets.
Leading Manufacturers and Suppliers
1. India
India dominates the Ibuprofen API market, boasting companies like Mitsubishi Tanabe Pharma, Aarti Industries, and BASF India. Indian plants typically operate under strict cGMP compliance, with export approvals from FDA, EMA, and WHO ([3]).
2. China
Chinese manufacturers such as Jiangsu Aosaikang Pharmaceutical Co., Jiangsu Hualun Pharmaceutical Co., and Liaoning North Chemical Industry are significant suppliers, often offering lower prices due to large-scale capacity ([4]).
3. Europe & North America
European companies such as Sanofi and Novartis produce Ibuprofen domestically, but their supply is primarily for branded formulations. North American demand is mostly met through imports from India and China.
Quality and Regulatory Dynamics
The US FDA's prior warning letters and quality audits have led some Chinese manufacturers to enhance compliance standards, leading to increased trust in suppliers who meet international quality benchmarks.
Pseudoephedrine Hydrochloride Suppliers
Overview
Pseudoephedrine Hydrochloride is a precursor in methamphetamine synthesis, but it is also a vital decongestant in medicinal formulations. Due to strict regulatory oversight, sourcing reliable suppliers requires careful vetting.
Primary Suppliers and Source Countries
1. India
India produces Pseudoephedrine Hydrochloride through licensed facilities regulated under the Drug Enforcement Administration (DEA) and local authorities. Key players include Sun Pharmaceutical Industries and Hetero Labs ([5]).
2. China
Chinese manufacturers such as Lonza (through subsidiaries) and Qingdao Sinomed Pharmaceutical supply Pseudoephedrine under strict licensing with emphasis on compliance, although residual regulatory scrutiny exists.
3. United States
The US relies heavily on imports due to legislative controls, with manufacturers like Ben Venue Laboratories holding licenses for legal production and export under the Controlled Substances Act.
Regulatory and Compliance Measures
Due to its status as a controlled substance, procurement involves rigorous licensing, secure transportation, and adherence to international treaties such as the UN's Controlled Substances Convention.
Market Trends and Supply Chain Challenges
Global Supply Chain Dynamics
The COVID-19 pandemic exposed vulnerabilities in the pharmaceutical supply chain, with many countries experiencing shortages of APIs, including Chlorpheniramine, Ibuprofen, and Pseudoephedrine. Reliance on India and China remains predominant, prompting strategic shifts towards diversification.
Quality Assurance and Certification
Regulatory agencies emphasize compliance with GMP, purity standards, and traceability. Suppliers with WHO prequalification or FDA approval are preferred for international markets.
Pricing and Cost Competitiveness
Manufacturers in India and China leverage cost advantages, although quality standards are increasingly scrutinized. North American and European firms focus on supplier partnerships with robust compliance to mitigate risks of recalls or regulatory actions.
Strategic Sourcing and Procurement Considerations
- Conduct comprehensive supplier audits focusing on GMP compliance, quality control, and regulatory certifications.
- Establish long-term partnerships with verified suppliers to ensure supply stability.
- Consider geo-diversification to mitigate geopolitical risks and tariff barriers.
- Evaluate supplier capacity for scale-up and responsiveness to market fluctuations.
Key Takeaways
- Indian and Chinese manufacturers dominate the API supply for Chlorpheniramine Maleate, Ibuprofen, and Pseudoephedrine Hydrochloride due to cost efficiency and capacity.
- Supplier verification based on regulatory compliance, GMP standards, and certification is critical for international market access.
- The growing emphasis on supply chain resilience encourages diversification strategies and potential near-shoring trends.
- Continuous regulatory scrutiny necessitates ongoing supplier audits and adherence to evolving Good Manufacturing Practices.
- Price should be balanced with quality assurance to mitigate risks associated with substandard APIs, ultimately safeguarding patient safety and brand reputation.
FAQs
1. How do I verify the legitimacy of an API supplier?
Conduct on-site audits, review regulatory certifications (FDA, WHO, EMA), request batch and quality certificates, and verify manufacturing licenses with relevant authorities.
2. Are Indian and Chinese suppliers reliable for high-quality APIs?
Yes, many Indian and Chinese manufacturers meet international standards. Prioritizing suppliers with recognized certifications and regulatory approvals ensures reliability.
3. What regulatory considerations are vital when sourcing Pseudoephedrine?
Strict compliance with local and international controls on controlled substances, including licensing, secure transportation, and recordkeeping, is essential.
4. How has the COVID-19 pandemic impacted API supply chains?
Disruptions have highlighted dependence on specific regions, prompting efforts to diversify suppliers and build more resilient supply chains.
5. Is there a trend towards onshoring API manufacturing for these drugs?
While onshoring is under consideration, cost, capacity, and regulatory factors currently favor established international suppliers; however, geopolitical and supply security concerns are influencing this trend.
References
- [1] Indian Pharmaceutical Alliance. “India’s API Manufacturing Capabilities.” Pharma Business Today, 2022.
- [2] Global Industry Analysts. “API Market Analysis: Focus on China and India.” Market Research Reports, 2021.
- [3] Pharmaceutical Technology. “Indian Manufacturers’ Quality Standards for Ibuprofen APIs.” Field Reports, 2022.
- [4] China Pharmaceutical News. “Chinese API Manufacturers: Market Overview and Regulatory Updates.” CQ News, 2022.
- [5] DEA Diversion Control Division. “Controlled Substances Act Regulations for Pseudoephedrine.” US Department of Justice, 2023.
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