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Suppliers and packagers for LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
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LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211059 | ANDA | WALGREEN CO. | 0363-9606-75 | 2 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK | 2022-08-03 |
| Aurobindo Pharma Ltd | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211059 | ANDA | WALGREEN CO. | 0363-9606-76 | 4 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK | 2022-08-03 |
| Aurobindo Pharma Ltd | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 211059 | ANDA | Better Living Brands, LLC | 21130-222-24 | 4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK | 2023-07-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LOPERAMIDE HYDROCHLORIDE and SIMETHICONE
Introduction
Loperamide hydrochloride combined with simethicone is a widely used over-the-counter medication for acute and chronic diarrhea management, especially effective in controlling symptoms associated with excessive intestinal motility and gas. Understanding the key suppliers of these active pharmaceutical ingredients (APIs) is critical for manufacturers, regulatory bodies, and healthcare providers aiming to ensure quality, supply stability, and compliance. This article provides a comprehensive overview of major global suppliers specializing in loperamide hydrochloride and simethicone, analyzing their capacities, regulatory standing, and market positioning.
Global Supply Landscape for Loperamide Hydrochloride
Loperamide Hydrochloride is a synthetic opioid receptor agonist that reduces gut motility, thereby controlling diarrhea. Although structurally related to opioid analgesics, it lacks central nervous system activity at therapeutic doses, categorizing it under antidiarrheal agents.
Major API Manufacturers and Suppliers
1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
As one of the leading Chinese pharmaceutical producers, Zhejiang Huahai manufactures high-quality loperamide hydrochloride API. The company adheres to cGMP standards and has obtained relevant regulatory approvals for its APIs, including certifications from the Chinese FDA (NMPA) and EU authorities.
2. Aarti Drugs Ltd. (India)
Aarti Drugs is a significant producer of loperamide hydrochloride, with a robust export footprint. Its facilities are WHO-GMP compliant, offering a reliable supply chain for global markets. The company emphasizes quality control and compliance with international standards.
3. Mylan (USA)
Mylan, now part of Viatris, supplies bulk quantities of loperamide hydrochloride. Although primarily a finished drug manufacturer, Mylan operates API manufacturing facilities capable of meeting global demand, often supplying to local and international generics producers.
4. Xi’an Tianshun Bio-Technique Co., Ltd. (China)
Specializing in APIs for gastrointestinal medications, this company supplies loperamide hydrochloride API to markets across Asia and Africa, with a focus on quality manufacturing under cGMP conditions.
Regulatory and Certification Insights
Leading suppliers maintain extensive Quality Management Systems (QMS) compliant with international standards like ICH Q7, USP, EP, and JP. Regulatory approvals such as DMF (Drug Master File) filings in the US FDA and CEP (Certificate of Suitability) in Europe bolster credibility.
Market Players for Simethicone
Simethicone is an anti-foaming agent that decreases surface tension of gas bubbles in the gastrointestinal tract, alleviating symptoms of bloating and flatulence. It is used in many OTC formulations and often combined with loperamide for effective symptom control.
Top Suppliers of Simethicone API
1. ShinEtsu Chemical Co., Ltd. (Japan)
As a pioneer in silicone-based products, ShinEtsu supplies high-purity simethicone globally. Its manufacturing facilities follow stringent quality standards, and it holds multiple certifications, including ISO 9001 and ISO 14001.
2. Dow Corning (USA)
Now part of Dow Inc., this company offers advanced siloxane-based APIs, including simethicone, benefiting from decades of silicone chemistry expertise. Their products are certified for pharmaceutical use and compliant with global regulatory standards.
3. Jiangsu Heben Pharmaceutical Co., Ltd. (China)
A prominent Chinese manufacturer of pharmaceutical-grade simethicone, Heben Pharmaceutical exports to numerous countries, emphasizing quality assurance and regulatory compliance.
4. Okay Micro Inc. (South Korea)
This South Korean firm produces high-concentration simethicone APIs and has achieved multiple ISO and GMP certifications, making it a reliable supplier in the Asian market.
5. Wacker Chemie AG (Germany)
A leading European chemical manufacturer, Wacker supplies high-purity, pharmaceutical-grade simethicone, with extensive regulatory documentation for strict compliance.
Supply Chain Considerations
Quality and Regulatory Compliance
Most leading suppliers adhere to cGMP, ISO, and ICH guidelines, ensuring APIs meet pharmacopeial standards such as USP, EP, and JP. Manufacturers and pharma companies should verify certifications and conduct audits for supply risk mitigation.
Capacity and Lead Times
Many suppliers maintain flexible manufacturing capacities, with some offering custom synthesis to cater to specific formulation needs. Lead times typically range from 4 to 12 weeks, depending on order size and regulatory approvals.
Global Presence and Logistics
China and India dominate the API supply chain for both loperamide hydrochloride and simethicone, supported by expanding manufacturing capacities and competitive pricing. European and Japanese suppliers serve premium markets with emphasis on high purity and regulatory standards.
Market Trends and Future Outlook
The global demand for loperamide hydrochloride and simethicone remains stable, driven by gastrointestinal health awareness and OTC market growth. Supply chains are increasingly converging around rigorous quality standards, with a focus on risk mitigation through supplier diversification. Additionally, regional regulatory landscapes influence supplier selection, with increased emphasis on GMP compliance and validated manufacturing processes.
Key Challenges for Suppliers
- Regulatory Shifts: Evolving regional regulations may impact API approvals, requiring suppliers to periodically update certifications and validation data.
- Supply Chain Disruptions: COVID-19 emphasized vulnerabilities in global supply chains, emphasizing the importance of dual sourcing and local manufacturing options.
- Quality Assurance: Maintaining high purity levels and consistent batch-to-batch quality is critical, given the safety profile of gastrointestinal APIs.
Key Takeaways
- Diverse Supplier Base: China, India, Japan, and Europe host prominent manufacturers supplying high-quality loperamide hydrochloride and simethicone APIs.
- Regulatory Alignment: Leading suppliers maintain widespread regulatory approvals, vital for international markets and ensuring compliance with global standards.
- Supply Chain Stability: Manufacturers should diversify sources to mitigate risks associated with regional disruptions, prioritize suppliers with proven track records and certifications.
- Quality Focus: Given the safety profile of these APIs, buyers must prioritize suppliers with robust quality management systems, validated processes, and transparent documentation.
- Market Evolution: Increasing demand for OTC gastrointestinal therapies suggests sustained necessity for reliable API supply chains, with ongoing innovations in quality and manufacturing scalability.
FAQs
1. How can I verify the quality of APIs from different suppliers?
Verify certifications such as cGMP, ISO, USP, EP, and JP. Request verification of cGMP compliance documentation, manufacturing process validation data, and third-party test reports.
2. What regions are most dominant in supplying loperamide hydrochloride and simethicone?
China and India lead in API manufacturing, with notable contributions from Japan and Europe supplying high-purity products for regulated markets.
3. Are there specific regulatory hurdles for importing these APIs?
Yes, regulatory agencies require GMP certification, registration documentation, and stability data. Importers must ensure suppliers hold valid DMFs, CEPs, or equivalent approvals.
4. What factors should influence the selection of a supplier?
Consider quality standards, regulatory compliance, capacity, certification, track record, price competitiveness, and supply chain reliability.
5. How is the market impacted by recent regulatory changes or patent expirations?
Patent expirations open opportunities for generics; concurrent regulatory requirements necessitate suppliers' compliance and adaptation to evolving standards, impacting supply consistency and market competition.
References
[1] APIs and Pharmaceutical Raw Materials Market Outlook. Global Industry Analysts, 2022.
[2] US FDA Drug Master File Program. FDA, 2023.
[3] European Pharmacopoeia. European Directorate for the Quality of Medicines & HealthCare, 2023.
[4] Chinese Pharmacopoeia, 2020.
[5] Industry Reports on Gastrointestinal API Markets. IQVIA, 2022.
This comprehensive overview aims to facilitate strategic sourcing decisions for stakeholders involved in the manufacturing and distribution of loperamide hydrochloride and simethicone-based pharmaceuticals.
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