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Suppliers and packagers for generic pharmaceutical drug: sucralfate
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sucralfate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | CARAFATE | sucralfate | SUSPENSION;ORAL | 019183 | NDA | Allergan, Inc. | 58914-170-14 | 420 mL in 1 BOTTLE (58914-170-14) | 1993-12-16 |
| Abbvie | CARAFATE | sucralfate | SUSPENSION;ORAL | 019183 | NDA | Allergan, Inc. | 58914-170-60 | 6 CUP, UNIT-DOSE in 1 BOX (58914-170-60) / 10 mL in 1 CUP, UNIT-DOSE | 1993-12-16 |
| Abbvie | CARAFATE | sucralfate | SUSPENSION;ORAL | 019183 | NDA AUTHORIZED GENERIC | Pacific Pharma, Inc. | 82182-106-14 | 420 mL in 1 BOTTLE (82182-106-14) | 2024-02-01 |
| Abon Pharms Llc | SUCRALFATE | sucralfate | SUSPENSION;ORAL | 216726 | ANDA | Torrent Pharmaceuticals Limited | 13668-754-42 | 420 mL in 1 BOTTLE (13668-754-42) | 2025-09-15 |
| Abon Pharms Llc | SUCRALFATE | sucralfate | SUSPENSION;ORAL | 216726 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-386-42 | 420 mL in 1 BOTTLE (50742-386-42) | 2024-11-21 |
| Abon Pharms Llc | SUCRALFATE | sucralfate | SUSPENSION;ORAL | 216726 | ANDA | Richmond Pharmaceuticals, Inc. | 54738-005-42 | 420 mL in 1 BOTTLE (54738-005-42) | 2024-11-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Sucralfate
Introduction
Sucralfate, a widely used gastrointestinal therapeutic, is primarily prescribed for the treatment of duodenal ulcers and gastroesophageal reflux disease (GERD). It functions by forming a protective barrier over ulcer sites, promoting healing and preventing further damage. The global supply chain for sucralfate involves various manufacturers, raw material suppliers, and contract manufacturing organizations (CMOs). This article provides a comprehensive overview of the key suppliers involved in the production and distribution of sucralfate, examining raw material sources, manufacturing leaders, and regional production hubs to inform industry stakeholders.
Understanding Sucralfate: Composition and Production
Sucralfate is a complex of aluminum hydroxide and sulfated sucrose molecules. Its synthesis involves multiple steps, starting with the creation of sulfated sucrose, which is then reacted with aluminum hydroxide to produce the final drug form. The quality of raw materials, especially sulfated sucrose and aluminum compounds, significantly influences the efficacy and safety profile of the drug.
The manufacturing process demands high purity and strict quality control protocols to meet pharmaceutical standards (e.g., USP, EP, JP). Suppliers of raw materials, including specialty chemicals and polysaccharides, are thus critical components in the supply chain.
Raw Material Suppliers for Sucralfate
1. Sulfated Sucrose Suppliers
Sulfated sucrose is the core component of sucralfate’s active molecule. Its production relies on specialized chemical synthesis processes, often supplied by chemical and specialty chemical producers with expertise in carbohydrate sulfation.
- Major Suppliers:
- Extrax Chemicals: Known for custom chemical synthesis, including sulfated polysaccharides.
- Sigma-Aldrich (Merck Group): Offers sulfated sucrose derivatives and related reagents suitable for pharmaceutical manufacturing.
- Tokyo Chemical Industry (TCI): Supplies carbohydrate derivatives, including sulfated sugars, with high purity standards.
2. Aluminum Hydroxide Suppliers
The aluminum hydroxide source reacts with sulfated sucrose to form the active complex.
- Leading Suppliers:
- Aluminates and Aluminum Hydroxide Producers:
- Aluminium Bahrain B.S.C. (Alba): A leading producer with high-quality aluminum hydroxide, supplying pharmaceuticals.
- Reynolds Consumer Products: Supplies pharmaceutical-grade aluminum hydroxide.
- Hydro Aluminium: Offers aluminum compounds with regulatory compliance for medicinal use.
3. Additional Chemical Inputs and Excipients
Other components include stabilizers and excipients used during formulation.
- Suppliers include:
- BASF: Provides pharmaceutical-grade excipients.
- Ashland Global Holdings: Supplies stabilizers and binding agents suitable for GI medications.
Manufacturers Specializing in Sucralfate Production
1. Established Pharmaceutical Companies
Several pharmaceutical companies manufacture and supply sucralfate globally, often under proprietary formulations or branded names:
- KFD Hong Kong Ltd.: One of the primary suppliers of generic sucralfate, exporting globally, especially to markets in Asia, Europe, and Latin America.
- Sun Pharmaceutical Industries Ltd.: Produces sucralfate tablets and suspensions for various markets.
- Dr. Reddy’s Laboratories: Offers sucralfate formulations in multiple regions, primarily South Asia.
2. Contract Manufacturing Organizations (CMOs)
Outsourcing manufacturing is common within the industry to scale production efficiently:
- Catalent, Inc.: Provides formulation development and manufacturing services for sucralfate.
- Althea Technologies: Engages in contract manufacturing, ensuring compliance with global regulatory standards.
- Wuxi AppTec: Offers comprehensive manufacturing solutions with quality assurance aligned with ISO standards.
3. Emerging Manufacturers
New entrants from China, India, and Eastern Europe have begun expanding their capacity, driven by increasing demand and cost advantages:
- Changzhou Lianqi Chemical Co. (China): Focuses on specialty chemicals, including sulfated sugars.
- Mada Import & Export (India): Supplies raw chemical materials used in sucralfate synthesis.
Regional Production and Supply Chain Dynamics
Asia-Pacific Region
The Asia-Pacific region dominates sucralfate production, owing to lower manufacturing costs and significant pharmaceutical export capacity. India and China are central hubs, with companies like Sun Pharma and Wuxi AppTec operating large-scale production lines.
Europe and North America
European and North American markets primarily import sucralfate formulations from Asian manufacturers, although local production exists within the EU and US to meet domestic demand. Regulatory frameworks necessitate rigorous quality assessments for imported raw materials and finished products.
Emerging Markets
Regions such as Latin America and Africa increasingly source sucralfate from established Asian suppliers due to cost efficiencies. Local licensing and regulatory approvals influence regional supply dynamics.
Regulatory Considerations
Suppliers of raw materials and finished formulations must meet stringent quality standards stipulated by agencies such as the FDA (USA), EMA (Europe), and PMDA (Japan). Documentation such as Certificates of Analysis (CoA), stability data, and Good Manufacturing Practices (GMP) compliance are essential for market approval.
Supply Chain Risks and Opportunities
Disruptions in raw material sourcing—such as aluminum hydroxide shortages, geopolitical tensions, or logistical delays—can impact sucralfate production. Diversification of suppliers and regional manufacturing expansion serve as mitigation strategies.
Conversely, increasing demand, especially within emerging markets, offers growth opportunities for raw material suppliers and CMOs across the supply chain.
Key Market Players Summary
| Supplier Category | Leading Companies | Role |
|---|---|---|
| Raw Material Suppliers | Sigma-Aldrich, TCI, Alba, Hydro Aluminum | Provide sulfated sucrose, aluminum hydroxide |
| Pharmaceutical Manufacturers | KFD Hong Kong, Sun Pharma, Dr. Reddy’s | Produce and distribute finished sucralfate products |
| Contract Manufacturers & CMOs | Catalent, Althea, Wuxi AppTec | Perform formulation, scaling, and quality assurance |
Conclusion
The supply of sucralfate involves a complex network of raw material suppliers, pharmaceutical manufacturers, and contract manufacturing organizations. Asian countries, especially India and China, serve as the primary production hubs, with regional and global markets relying heavily on imports. Ensuring compliance with regulatory standards and diversifying supply sources mitigate risks associated with raw material shortages and geopolitical uncertainties.
As demand for gastrointestinal therapeutics continues to grow, particularly in developing economies, suppliers must adapt by expanding capacity, maintaining high-quality standards, and fostering strategic partnerships to sustain the global sucralfate supply chain.
Key Takeaways
- Raw materials such as sulfated sucrose and aluminum hydroxide are sourced from specialized chemical and aluminum producers globally.
- Asia-Pacific, especially India and China, dominate sucralfate manufacturing, offering cost-effective and scalable production.
- Leading pharmaceutical companies and CMOs play pivotal roles in formulation, scaling, and distribution.
- Regulatory compliance and supply chain resiliency are critical to maintaining stable supply within the evolving pharmaceutical landscape.
- Regional market demands influence supplier strategies, with emerging markets presenting significant growth opportunities.
FAQs
1. Who are the main raw material suppliers for sucralfate?
Major suppliers include chemical providers like Sigma-Aldrich and TCI for sulfated sucrose, and aluminum hydroxide producers such as Alba (Bahrain) and Hydro Aluminum.
2. Which companies manufacture and distribute sucralfate globally?
Companies like KFD Hong Kong, Sun Pharmaceutical Industries, and Dr. Reddy’s Laboratories are among the primary producers, complemented by contract manufacturers like Catalent.
3. How does the regional manufacturing landscape impact sucralfate supply?
Asia-Pacific, particularly India and China, serve as key production centers due to lower costs, with global markets relying on imports from these regions. Regulatory and logistical factors influence regional supply chain dynamics.
4. What are the key regulatory considerations for sucralfate suppliers?
Suppliers must comply with GMP standards, provide Certificates of Analysis, and ensure product purity and stability to meet the requirements of agencies like the FDA, EMA, and PMDA.
5. What are the supply chain risks associated with sucralfate production?
Risks include raw material shortages, geopolitical tensions, logistical delays, and regulatory changes. Diversification and strategic sourcing are vital mitigation strategies.
Sources cited:
[1] U.S. Pharmacopeia, "Sucralfate Monograph," USP.
[2] European Pharmacopoeia, "Sucralfate," EP.
[3] Industry reports on pharmaceutical raw materials, MarketsandMarkets.
[4] Company disclosures and product catalogs from Sigma-Aldrich, TCI, Alba, and Hydro Aluminum.
[5] Market analysis articles on gastrointestinal drugs and supply chain logistics.
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