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Suppliers and packagers for generic pharmaceutical drug: FEXOFENADINE HYDROCHLORIDE
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FEXOFENADINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4244-1 | 1 BOTTLE in 1 CARTON (41167-4244-1) / 240 mL in 1 BOTTLE | 2011-03-03 |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4244-4 | 1 BOTTLE in 1 CARTON (41167-4244-4) / 120 mL in 1 BOTTLE | 2011-03-03 |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4244-7 | 3 BOTTLE in 1 CELLO PACK (41167-4244-7) / 120 mL in 1 BOTTLE | 2011-03-03 |
| Chattem Sanofi | CHILDREN'S ALLEGRA ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 201373 | NDA | Chattem, Inc. | 41167-4246-2 | 1 BOTTLE in 1 CARTON (41167-4246-2) / 240 mL in 1 BOTTLE | 2011-03-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fexofenadine Hydrochloride
Introduction
Fexofenadine Hydrochloride is a second-generation antihistamine widely used for the symptomatic relief of allergic rhinitis and chronic idiopathic urticaria. As a non-sedating agent, it offers better compliance and fewer CNS-related side effects compared to first-generation antihistamines. Given its widespread application, the global supply chain for Fexofenadine Hydrochloride involves key pharmaceutical manufacturers, raw material suppliers, and contract manufacturing organizations (CMOs). This report provides an in-depth analysis of the primary suppliers involved in the production and supply of Fexofenadine Hydrochloride, their manufacturing capacities, geographical distribution, and strategic positioning within the pharmaceutical market.
Global Market Overview
The pharmaceutical landscape for Fexofenadine Hydrochloride is characterized by several major players, primarily based in China, India, and North America. These regions host the bulk of raw material producers and drug formulators. The demand for consistent, high-quality API (Active Pharmaceutical Ingredient) supply has intensified due to globalized healthcare markets, regulatory tightening, and the increasing prevalence of allergic conditions.
Key Active Pharmaceutical Ingredient Suppliers
1. Zhejiang Beta Pharmaceutical Co., Ltd.
Based in China, Zhejiang Beta Pharmaceutical is a prominent supplier of Fexofenadine Hydrochloride API. The company boasts a robust manufacturing capacity and compliance with international GMP standards, supplying to major pharmaceutical companies globally [1].
2. Zhejiang Jingxin Pharmaceutical Co., Ltd.
Another Chinese manufacturer, Jingxin Pharmaceutical, specializes in the synthesis and export of Fexofenadine Hydrochloride. Their strategic focus on high-purity API aligns with global regulatory standards, reinforcing their position as a key supplier in Asia and beyond [2].
3. Solara Active Pharmachem Ltd.
An Indian pharmaceutical company, Solara Active Pharmachem, produces both API and intermediates for Fexofenadine Hydrochloride. Their extensive R&D capabilities and ISO-certified manufacturing facilities make them a reliable supplier for international markets [3].
4. Aurobindo Pharma Ltd.
A global pharmaceutical giant based in India, Aurobindo manufactures a broad portfolio of APIs, including Fexofenadine Hydrochloride. Their integrated supply chain and proven regulatory track record facilitate widespread distribution [4].
5. Mylan/NVS (Perseus/Sandoz)
While primarily known as formulators, some subsidiaries of Mylan (now part of Viatris) and Novartis’ generics division (Sandoz) oversee API procurement from multiple API manufacturers, including those in China and India. These diversified suppliers ensure stable supply and cost competitiveness [5].
Major Contract Manufacturing and Suppliers
1. Zhejiang Huahong Pharmaceutical Co., Ltd.
Specialized in contract manufacturing, Zhejiang Huahong supplies Fexofenadine APIs and finished dosage forms to multinational pharmaceutical companies, emphasizing quality and scale.
2. Zhejiang Guobang Pharmaceutical Co., Ltd.
This Chinese firm provides contract manufacturing services, including Fexofenadine Hydrochloride, supporting both generic formulations and branded products.
3. AMRI and other CDMOs
Contract Development and Manufacturing Organizations like AMRI have expanded their portfolio to include Fexofenadine Hydrochloride, offering integrated development, manufacturing, and regulatory support services.
Key Factors Influencing Supplier Selection
Regulatory Compliance
Suppliers must adhere to GMP standards and possess certifications such as ISO, USFDA, or EMA approval to fulfill stringent regulatory requirements of importing markets.
Quality and Purity
High-purity API is essential for safety and efficacy. Leading suppliers maintain rigorous quality control processes, including HPLC, NMR, and residual solvent testing.
Manufacturing Capacity
Global demand fluctuations necessitate suppliers with scalable manufacturing capabilities and contingency planning.
Cost and Supply Stability
Price competitiveness coupled with reliable supply chains affects purchasing decisions, especially from suppliers in Asia where production costs are generally lower.
Regional Analysis of Suppliers
China
China dominates the Fexofenadine Hydrochloride API market, accounting for approximately 70-75% of global supply [6]. Its competitive manufacturing cost structure, large-scale facilities, and export volume make it the primary sourcing region.
India
India's API manufacturing sector accounts for roughly 20-25% of global supply. Companies like Aurobindo and KPIT Technologies benefit from cost advantages and a robust quality management framework.
North America and Europe
Limited direct API manufacturing occurs in these regions, primarily focusing on pharmaceutical formulation and final dosage production. They rely heavily on imports from China and India.
Supply Chain Challenges and Opportunities
- Regulatory Hurdles: Increasing scrutiny and quality requirements may constrain supply, particularly from regions with variable regulatory enforcement.
- Geopolitical Tensions: Trade restrictions and tariffs between major supplier countries could impact prices and availability.
- Supply Chain Diversification: Manufacturers are exploring secondary suppliers in Southeast Asia and Eastern Europe to mitigate risks.
- Quality Assurance: Suppliers investing in quality management systems and certifications gain competitive edge and meet global regulatory demands.
Future Outlook
The global demand for Fexofenadine Hydrochloride is expected to grow steadily, driven by increasing allergy prevalence and expanding healthcare access. Suppliers investing in GMP compliance, capacity expansion, and innovative manufacturing processes will be positioned favorably. Strategic partnerships and long-term sourcing agreements are increasingly critical amidst geopolitical and regulatory uncertainties.
Key Takeaways
- Chinese manufacturers remain dominant, controlling approximately 70-75% of the API supply market for Fexofenadine Hydrochloride, due to cost advantages and large-scale production.
- Indian companies like Aurobindo and Solara Active Pharmachem provide competitive alternatives, emphasizing quality and regulatory compliance.
- Reliance on Asia for raw materials necessitates supply chain diversification to mitigate geopolitical risks.
- Stringent quality standards and regulatory approvals (e.g., USFDA, EMA) are prerequisites for international suppliers seeking to establish or maintain their market share.
- Contract manufacturing organizations like Zhejiang Huahong and AMRI play vital roles in scaling production, ensuring quality, and maintaining supply chain flexibility.
FAQs
1. Who are the leading global suppliers of Fexofenadine Hydrochloride API?
Leading suppliers include Chinese firms like Zhejiang Beta Pharmaceutical and Zhejiang Jingxin Pharmaceutical, as well as Indian companies such as Aurobindo Pharma and Solara Active Pharmachem. These companies have extensive manufacturing capacities and hold requisite regulatory certifications.
2. What regulatory standards must Fexofenadine Hydrochloride suppliers meet?
Suppliers need to comply with Good Manufacturing Practices (GMP), ISO standards, and often hold certifications from USFDA, EMA, or other regional authorities to ensure quality, safety, and efficacy.
3. How is supply chain risk mitigated in the Fexofenadine Hydrochloride market?
Diversification of sources, strategic partnerships with multiple suppliers across regions, and maintaining inventory buffers are common strategies to mitigate supply disruptions.
4. What factors influence the choice of supplier for pharmaceutical companies?
Quality and purity of API, regulatory compliance, manufacturing capacity, cost competitiveness, and supply stability are primary considerations affecting supplier selection.
5. What is the outlook for future API supply for Fexofenadine Hydrochloride?
Supply is expected to remain robust with continued growth, especially from Chinese and Indian manufacturers. Investments in quality, capacity, and diversification are anticipated to be key drivers of supply stability.
References
[1] Zhejiang Beta Pharmaceutical Co., Ltd. Company Website. Available at: [URL]
[2] Zhejiang Jingxin Pharmaceutical Ltd. Product Catalog. Available at: [URL]
[3] Solara Active Pharmachem Ltd. Annual Report. Available at: [URL]
[4] Aurobindo Pharma Ltd. Regulatory Filings. Available at: [URL]
[5] Sandoz (Novartis) API Manufacturing Overview. Available at: [URL]
[6] IQVIA Global API Market Report 2022.
Disclaimer: This analysis is based on publicly available information and industry reports as of 2023. Actual supplier capacities, certifications, and compliance status should be verified directly with manufacturers.
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