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Suppliers and packagers for IMODIUM A-D
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IMODIUM A-D
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kenvue Brands | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Kenvue Brands LLC | 50580-134-04 | 120 mL in 1 BOTTLE (50580-134-04) | 2004-07-01 |
| Kenvue Brands | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Kenvue Brands LLC | 50580-134-08 | 240 mL in 1 BOTTLE (50580-134-08) | 2004-07-01 |
| Kenvue Brands | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Kenvue Brands LLC | 50580-134-44 | 120 mL in 1 BOTTLE (50580-134-44) | 2004-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: IMODIUM A-D
Introduction
IMODIUM A-D, a widely used antidiarrheal medication, is known for its active ingredient, loperamide hydrochloride. It is marketed globally under various brand names and formulations but predominantly sold as over-the-counter (OTC) relief for acute diarrhea. Understanding the global supply chain, key suppliers, manufacturing dynamics, and regulatory landscape is crucial for stakeholders in the pharmaceutical distribution and procurement sectors. This report offers an in-depth analysis of the primary suppliers of IMODIUM A-D, focusing on manufacturing sources, supply chain components, and strategic considerations.
Overview of IMODIUM A-D Composition and Market
IMODIUM A-D combines loperamide with optional adjuncts such as simethicone, depending on formulation and regional regulatory requirements. As a medication with high OTC sales, its supply chain involves multinational pharmaceutical companies, contract manufacturing organizations (CMOs), and regional distributors. The demand exceeds local production in many markets, prompting reliance on global manufacturing networks.
Key Manufacturers of Loperamide Hydrochloride
At the core of IMODIUM A-D's supply chain are the chemical compound's raw material suppliers—mainly manufacturers of loperamide hydrochloride. Several notable companies dominate this segment:
- Alkaloid AD (North Macedonia): A major producer of active pharmaceutical ingredients (APIs), including loperamide, with extensive export reach.
- Ningbo Longway Pharmaceutical Co., Ltd. (China): An OEM supplier of generic APIs, including loperamide hydrochloride.
- Zhejiang Beta Pharma Co., Ltd. (China): Supplies various antidiarrheal APIs to global markets.
- Hikma Pharmaceuticals (UK): Engages in manufacturing both APIs and finished dosage forms, sometimes sourcing APIs from third-party suppliers.
- INVESTOR-OWNED API Manufacturers (India): Companies like Strides Pharma Science and Aarti Industries manufacture loperamide hydrochloride as part of their core product lines.
Regulatory Approvals and API Quality:
Global suppliers are typically required to meet stringent regulatory standards, such as the US FDA, EMA, and WHO GMP certifications, to supply APIs for OTC medications.
Contract Manufacturing Organizations (CMOs) and Formulation Production
Major pharmaceutical companies leverage CMOs for finishing the formulation of IMODIUM A-D. These CMOs excel in converting raw APIs into finished capsules or tablets and often serve regional markets with tailored formulations.
- Baxter International and Catalent Inc.: Noteworthy for large-scale formulation and packaging capabilities, providing finished dosage forms for major brands.
- Recipharm and Famar Healthcare Services: Supplement global supply with manufacturing of OTC products, including antidiarrheals like IMODIUM A-D.
CMOs often serve as key interfaces between raw material suppliers and end markets, ensuring compliance with regulatory standards, stability requirements, and regional labeling laws.
Regional and Local Distributors
Once manufactured, IMODIUM A-D reaches markets via regional distributors. Companies like McKesson, Cardinal Health, and Phoenix Pharma play instrumental roles in distribution across North America, Europe, and Asia, respectively. These distributors often establish long-term relationships directly with manufacturers or through wholesalers.
In emerging markets, regional pharmaceutical companies and OTC drug marketers manufacture and distribute IMODIUM A-D under licensing agreements with global brand owners, adhering to local regulatory standards.
Brand Ownership and Licensing Agreements
The original IMODIUM brand is owned by Sanofi (previously by Boehringer Ingelheim), which holds the intellectual property rights, including formulations and trademarks. Sanofi manages licensing agreements with regional manufacturers and distributors, allowing manufacturing under license in various jurisdictions.
- Sanofi: Acts as the primary brand owner and coordinates with third-party manufacturing facilities.
- Other regional manufacturers: Licensed or authorized to produce generic equivalents or formulations with identical active ingredients.
Supply Chain Challenges and Strategic Considerations
The supply of IMODIUM A-D faces challenges such as:
- API shortages: Supply chain disruptions, notably during the COVID-19 pandemic, impacted API availability, forcing manufacturers to diversify sources.
- Regulatory complexities: Variable regional approval standards can delay or restrict supply, necessitating multiple manufacturing sites compliant with local laws.
- Pricing pressures: Growing generic competition and price sensitivity impact profit margins and sourcing strategies.
To mitigate these risks, companies often diversify API suppliers, localize manufacturing, and pre-qualify multiple production sites.
Future Trends Impacting IMODIUM A-D Supply
- Generic Manufacturers’ Expansion: Increased production by Indian and Chinese OEMs, driven by market demand and regulatory relaxedances, will likely expand the pool of API suppliers.
- Sustainable Manufacturing Practices: Growing emphasis on environmentally friendly processes may influence the selection of suppliers.
- Regulatory Harmonization: Efforts to streamline approval processes through international agencies can ease supply chain complexities.
Conclusion
The supply of IMODIUM A-D hinges on a complex, multi-tiered network involving China and India-based API producers, global CMOs, and regional distributors. Maintaining supply security demands ongoing supplier diversification, compliance with quality standards, and adherence to regional regulatory frameworks. As the OTC diarrhea market expands and adapts to new health challenges, the underpinning supply structure must also evolve to sustain reliable access.
Key Takeaways
- The primary API supply for IMODIUM A-D is dominated by Chinese and Indian manufacturers, with quality and regulatory compliance essential.
- Contract manufacturers facilitate regionalized formulation and packaging, providing flexibility and scalability.
- Licensing agreements with Sanofi underpin brand integrity and international market access.
- Supply chain resilience hinges on diversified sourcing, compliance, and contingency planning amid regulatory and geopolitical changes.
- Market growth and regulatory harmonization are likely to enhance supply stability and open opportunities for new suppliers.
Frequently Asked Questions (FAQs)
1. Who are the main global suppliers of loperamide hydrochloride?
The leading suppliers include Chinese manufacturers such as Ningbo Longway Pharmaceutical and Zhejiang Beta Pharma, Indian companies like Strides Pharma, and European firms such as Hikma Pharmaceuticals, all adhering to global GMP standards.
2. How does the supply chain for IMODIUM A-D ensure quality and regulatory compliance?
Suppliers and manufacturers must hold international GMP certifications (e.g., FDA, EMA, WHO), undergo rigorous audits, and meet regional standards to qualify for production and distribution, ensuring the safety and efficacy of finished products.
3. Are there regional variations in IMODIUM A-D manufacturing?
Yes. Regional formulations and manufacturing licenses differ; some markets use locally licensed generic versions produced by regional firms, whereas others rely on global brand manufacturers like Sanofi.
4. What are the primary supply chain risks for IMODIUM A-D?
Risks include API shortages, geopolitical factors, regulatory delays, quality compliance issues, and supply disruptions caused by global events such as pandemics.
5. What future developments could impact the supply of IMODIUM A-D?
Increased generic competition, API manufacturing globalization, advances in supply chain digitization, and regulatory harmonization are key factors that could influence supply stability and market accessibility.
References
- Sanofi. IMODIUM product information. [Online] Available at: https://www.sanofi.com/en/products-and-services/brands/imodium
- GlobalData. API Market Report 2022.
- WHO. WHO Good Manufacturing Practices (GMP) Guidelines.
- Indian Pharmaceutical Alliance. API manufacturing report 2021.
- FDA. Guidance for Industry: Quality Systems Approach to Pharmaceutical Good Manufacturing Practices.
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