Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589 | NDA | Ferring Pharmaceuticals Inc. | 55566-6800-1 | 2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0) | 2023-03-29 |
| Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589 | NDA | Ferring Pharmaceuticals Inc. | 55566-6800-2 | 2 BOTTLE in 1 CARTON (55566-6800-2) / 175 mL in 1 BOTTLE (55566-6800-0) | 2023-03-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Citric Acid, Magnesium Oxide, and Sodium Picosulfate
What suppliers supply citric acid for pharmaceutical use?
Key supplier categories for citric acid (API/intermediate grade into pharma supply chains) include global chemical manufacturers and pharma-grade excipient suppliers.
Common manufacturer/excipient supply sources for citric acid
| Supplier | Common positioning | Likely product fit (pharma track) |
|---|---|---|
| Cargill | Ingredient supplier | Food/pharma excipient supply lines for citric acid |
| Corbion | Food and industrial ingredients | Citric acid production for regulated markets |
| DuPont Nutrition & Biosciences / IFF (through legacy arrangements) | Ingredient supplier | Citric acid supply for formulation industries |
| Kerry | Ingredient supplier | Specialty ingredient distribution for regulated excipients |
| ADM (Archer Daniels Midland) | Ingredient supplier | Citric acid ingredient supply through commercial channels |
What suppliers supply magnesium oxide for pharmaceutical use?
Magnesium oxide enters pharma supply chains primarily as a mineral excipient (tablet/capsule formulations, antacid use) and as a processing/functional excipient.
Common manufacturer/excipient supply sources for magnesium oxide
| Supplier | Common positioning | Likely product fit (pharma track) |
|---|---|---|
| RHI Magnesita | Specialty materials | MgO supply via technical/regulated materials channels |
| Premier Magnesia | MgO producer | MgO excipient-grade supply for industrial and pharma buyers |
| Minera Alumbrera / local producers (regional) | Mineral processing | MgO supply in regional regulated procurement programs |
| Treibacher Industrie / related chemical group suppliers | Chemical materials | MgO supply for specialty formulations |
| Nabaltec | Specialty minerals | MgO-containing and magnesium compounds supply into excipient chains |
What suppliers supply sodium picosulfate for pharmaceutical use?
Sodium picosulfate is an active laxative ingredient. Commercial supply is typically handled via:
- API manufacturers (for product dossiers and market authorization),
- licensed distributors and importers in specific regions,
- excipient/API intermediates depending on regulatory scope.
Common supplier categories for sodium picosulfate
| Supplier type | Typical role | Procurement trigger |
|---|---|---|
| API manufacturers | Produce sodium picosulfate API under GMP | Marketing authorization API sourcing |
| Licensed chemical distributors | Provide import and regulatory documentation | Finished dosage manufacturers |
| Contract manufacturers | Package/label or generate local supply | Regional market launch timelines |
Notable global sodium picosulfate API supply sources
| Supplier | Common positioning | Likely product fit (API track) |
|---|---|---|
| Hangzhou Dayangchem Co., Ltd. | Specialty chemicals | Sodium picosulfate supply into regulated chemical markets |
| TCI Chemicals | Specialty chemical manufacturer | Sodium picosulfate availability through research and industrial channels |
| MedChemExpress | Specialty chemical supplier | Sodium picosulfate availability for R&D scale |
| LGC / Sigma-Aldrich branded channels | Chemical distribution | Often R&D/industrial grade; pharma-grade requires vendor qualification |
What supplier documentation typically matters for pharma sourcing of these three chemicals?
For all three materials, buyers typically require vendor documentation that maps to GMP/controlled supply chain expectations:
-
For citric acid and magnesium oxide (excipients/processing aids):
- CoA and specification sheet (assay, identity, impurities, heavy metals)
- Particle size and bulk density data (when relevant)
- Traceability and lot-to-lot consistency documentation
-
For sodium picosulfate (API):
- GMP manufacturing status (or equivalent)
- Full specification + impurity profile
- Stability and packaging configuration documentation
- Regulatory compatibility (DMF/CEP readiness in the downstream market)
How to structure vendor qualification across the three materials
A consistent qualification workflow across citric acid, magnesium oxide, and sodium picosulfate reduces supply risk and regulatory friction:
-
Confirm intended regulatory category
- Citric acid and magnesium oxide: excipient or processing aid
- Sodium picosulfate: API
-
Lock the spec before sample qualification
- Assay, impurity limits, identity methods, heavy metals, and microbiological controls where required
-
Run packaging and supply chain verification
- Storage conditions and shelf-life alignment
- Documentation quality (CoA format, test methods, and sign-off authority)
-
Establish change control triggers
- Manufacturing site, process changes, supplier batch-to-batch variability
Key Takeaways
- Citric acid sourcing is dominated by large global ingredient producers and pharma excipient suppliers.
- Magnesium oxide sourcing typically comes from mineral-based specialty materials producers with excipient-grade programs.
- Sodium picosulfate supply is API-focused; vendor qualification and GMP documentation are decisive for downstream pharma use.
- Buyers should align each material to its regulatory category, confirm specs early, and enforce change control based on lot-to-lot performance.
FAQs
-
Can the same supplier provide citric acid and magnesium oxide for pharma formulations?
Yes, some specialty chemical producers supply both as excipients, but pharma-grade acceptance depends on each material’s specific CoA/spec and GMP documentation. -
Is sodium picosulfate always available as pharma-grade API from chemical retailers?
No. Many specialty chemical channels carry R&D or industrial grade; pharma use requires GMP-aligned API supply and compliant documentation. -
What documentation is non-negotiable for sodium picosulfate API sourcing?
CoA/spec with impurity profile, identity and test methods, GMP status, and stability or shelf-life data consistent with the downstream dosage form. -
Do citric acid and magnesium oxide need heavy metals controls?
Yes in most pharma excipient specifications; buyers typically require compliance for metals and relevant impurity thresholds. -
What sourcing model reduces supply disruption risk across all three materials?
Dual-source qualification per material, with pre-agreed spec acceptance criteria and strict lot-to-lot comparison protocols.
References
[1] Cargill. Citric acid product information and ingredient portfolio. (Company website).
[2] Corbion. Citric acid manufacturing and ingredient supply information. (Company website).
[3] RHI Magnesita. Magnesium oxide and related materials product information. (Company website).
[4] Premier Magnesia. Magnesium oxide and magnesia product information. (Company website).
[5] Hangzhou Dayangchem Co., Ltd. Sodium picosulfate product listing. (Company website).
[6] TCI Chemicals. Sodium picosulfate product listing. (Company website).
[7] MedChemExpress. Sodium picosulfate product listing. (Company website).
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