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Suppliers and packagers for 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
SUCRALFATE Drug Suppliers: API and Finished-Dose Supply Landscape
Who supplies sucralfate active pharmaceutical ingredient (API)?
Sucralfate is a widely manufactured generic API used in oral ulcer treatment. The supply base is dominated by manufacturers producing sucralfate (anhydrous) and/or sucralfate prepared as pharmaceutical-grade powders or granules for downstream tableting. Major commercial supply typically comes from API manufacturers in India and China, plus a smaller set of Western and Japanese specialty chemical producers.
Which companies are active in sucralfate API supply (commercially listed) ?
The following entities are established participants in sucralfate API and related bulk supply chains, based on published catalog listings and/or specialty chemical/pharma bulk listings that explicitly include sucralfate:
| Supplier/Company | Supply role (API or bulk) | Notes (what they list publicly) |
|---|---|---|
| BASF | Bulk chemical supply (industry footprint) | Sucralfate is within BASF’s broad pharmaceutical-grade chemical manufacturing portfolio; bulk supply presence is reflected across historical pharma sourcing networks. |
| Tianjin Eco-Pharm / EcoPharm | API/bulk supply | Public listings include sucralfate as a catalog item for pharmaceutical/bulk buyers. |
| Zhejiang Huahan (Huahan Pharma) | API/bulk supply | Public pharma-ingredient catalogs include sucralfate for commercial sourcing. |
| Lianyungang Xinhua (Xinhua Chemical) | API/bulk supply | Bulk sucralfate appears in supplier catalogs for industrial/pharma procurement. |
| Shanghai Tauto Biotech | API/bulk supply | Public commercial listings include sucralfate. |
| MedChemExpress (MCE) | Research-grade bulk (catalog) | Lists sucralfate for bulk procurement for R&D or non-commercial use. |
| Bide Pharm / Bide Pharmaceutical | API/bulk supply | Public sourcing listings for sucralfate as an ingredient. |
Procurement reality: many buyers purchase sucralfate from multiple suppliers to mitigate raw-material and manufacturing batch variability, especially because sucralfate manufacture depends on controlled chemistry and particle specs.
Which suppliers support finished-dose sucralfate tablets/suspensions (contract manufacturing and distributors)?
Finished-dose sucralfate (tablets and oral suspensions in different markets) is commonly produced by multiple generic manufacturers under local marketing authorizations, and distributed through regional pharma supply channels.
Because national tender and authorization status differ by country, supplier identification for finished-dose products typically maps to the marketing authorization holders and their distribution partners in each jurisdiction.
What should buyers require from sucralfate suppliers (quality and documentation)?
For sucralfate API, procurement teams typically enforce these requirements (aligned to standard pharmaceutical quality expectations and GMP procurement norms):
Core quality documents
- Certificate of Analysis (CoA) per lot (assay and key impurities)
- GMP certificate (site audit reports or regulatory GMP status)
- Drug Master File (DMF) or relevant regulatory filing support where applicable
- Technical Data Package: specs, test methods, impurity profile
Typical API specification points used in sucralfate purchasing
Sucralfate specifications generally include:
- Identity (chemical identity confirmation)
- Assay (sucralfate content)
- Loss on drying and moisture
- Particle/physical characteristics (depending on grade)
- Sulfated ash / relevant residues (process-dependent)
- Impurities (process related and raw material related)
- Microbial limits (for oral-solid manufacturing requirements)
How does supplier choice affect manufacturing outcomes for sucralfate?
Sucralfate’s performance can vary with:
- Degree of polymerization / physicochemical properties (influences suspension behavior and dissolution profile)
- Particle size distribution (impacts tablet uniformity and suspension viscosity)
- Moisture content and handling stability (affects granulation and compression)
- Impurity profile (can affect stability and release testing)
Procurement teams reduce risk by qualifying suppliers through:
- incoming spec compliance plus stability checks
- comparative dissolution performance for the intended dosage form
What is the typical procurement model for sucralfate (API vs intermediate)?
Most commercial supply uses: 1) Direct API purchasing (pharma-grade sucralfate) 2) Contract manufacture of finished dosage forms using supplier-qualified API grades 3) In some cases, use of bulk sucralfate grades with tighter in-house testing for dissolution and physical performance
Key Takeaways
- Sucralfate sourcing is typically handled through a multi-supplier API model, with procurement emphasizing GMP status, CoA lot-by-lot, and strict physicochemical and impurity specifications.
- API supply participation is concentrated among established bulk-pharma ingredient companies with public catalog listings for sucralfate, especially in Asia.
- Finished-dose supply depends on country-specific marketing authorization holders and local distributors, with contract manufacturing tied to the approved API grade and formulation process controls.
FAQs
1) Is sucralfate API widely available globally?
Yes. Sucralfate is a mature generic API and is commonly stocked by bulk pharma ingredient suppliers.
2) What documents should a buyer require for sucralfate API?
A lot-specific CoA, supplier GMP status, and a technical data package with specs and methods are standard.
3) Do sucralfate suppliers differ in performance-relevant properties?
Yes. Particle and physicochemical characteristics can differ by grade and manufacturing process, impacting dissolution and suspension behavior.
4) Who supplies finished sucralfate tablets and suspensions?
Finished-dose products typically come from local generic manufacturers and their contract manufacturing networks, depending on regulatory authorization in each country.
5) How do buyers manage supply risk for sucralfate?
They qualify multiple suppliers, run incoming testing against the intended spec, and validate performance in the target dosage form.
References
[1] BASF. Product and pharmaceutical chemical supply footprint (corporate and historical industry sourcing materials).
[2] Public supplier catalog listings for sucralfate (Tianjin Eco-Pharm/EcoPharm, Zhejiang Huahan, Lianyungang Xinhua Chemical, Shanghai Tauto Biotech, Bide Pharm, MedChemExpress).
[3] Industry GMP procurement standard practice for API documentation (CoA, GMP certificates, technical data packages).
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