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Suppliers and packagers for generic pharmaceutical drug: magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate
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magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Braintree Labs | SUFLAVE | magnesium sulfate; polyethylene glycol 3350; potassium chloride; sodium chloride; sodium sulfate | FOR SOLUTION;ORAL | 215344 | NDA | Braintree Laboratories, Inc. | 52268-550-01 | 1 KIT in 1 KIT (52268-550-01) | 2023-06-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Analysis of Pharmaceutical Suppliers for Magnesium Sulfate, Polyethylene Glycol 3350, Potassium Chloride, Sodium Chloride, and Sodium Sulfate
The global pharmaceutical supply chain relies on a network of specialized manufacturers and distributors to provide critical active pharmaceutical ingredients (APIs) and excipients. This report analyzes key suppliers for five essential compounds—magnesium sulfate, polyethylene glycol (PEG) 3350, potassium chloride, sodium chloride, and sodium sulfate—highlighting their regulatory certifications, production capabilities, and market roles. Recent trends, including surging demand for magnesium-based therapeutics and geopolitical trade dynamics, underscore the importance of robust supplier networks in maintaining drug availability.
Magnesium Sulfate Suppliers: Certification and Market Dynamics
Regulatory Compliance and Major Suppliers
Magnesium sulfate, widely used in electrolyte replenishment and laxative formulations, is supplied by manufacturers adhering to stringent quality standards. Noah Chemicals (U.S.) produces heptahydrate and anhydrous forms compliant with ACS reagent standards, serving aerospace, cosmetics, and pharmaceutical sectors[2]. Spectrum Chemical offers USP/EP-grade magnesium sulfate heptahydrate manufactured under FDA Drug Master File (DMF #31105) in a cGMP facility, ensuring suitability for parenteral applications[12]. International suppliers like Fujifilm Wako Pure Chemical Corporation (Japan) and Jost Chemical (U.S.) further diversify the market, with certifications spanning ISO 9001:2015 and ICH Q7[11].
Market Trends and Trade Challenges
The North American magnesium sulfate market experienced a price surge in January 2025, driven by 220% year-on-year demand growth for magnesium creams in personal care[1]. Despite feedstock shortages of sulfuric acid in China, exports to the U.S. reached record levels, partly due to preemptive stockpiling ahead of anticipated tariffs[1]. This underscores the fragility of global supply chains, where geopolitical tensions directly impact API availability.
Polyethylene Glycol 3350: Excipient Suppliers and Formulation Partnerships
Key Manufacturers and Regulatory Frameworks
PEG 3350, a polymer excipient essential for bowel preparation solutions like Suflave, is supplied by manufacturers specializing in GMP-compliant production. Euroapi and SPI Pharma are prominent API suppliers, while BASF and Ashland provide PEG derivatives for drug delivery systems[7]. DuPont Pharma Solutions leverages its expertise in laxative formulations to offer PEG 3350 tailored for osmotic balance in products such as GoLYTELY[7].
Role in Combination Therapies
In Suflave, PEG 3350 is combined with electrolytes like sodium sulfate and magnesium sulfate to enhance colon cleansing efficacy[16]. Suppliers must ensure batch consistency to meet FDA monographs, as deviations in molecular weight distribution can alter drug absorption rates.
Potassium Chloride: Sourcing for Electrolyte Formulations
Supplier Landscape and Quality Control
Potassium chloride, critical for treating hypokalemia, is supplied by Noah Chemicals (U.S.) in 99.9% purity for pharmaceutical and nutraceutical applications[2][13]. Pharm-RX Chemical Corporation offers USP-grade potassium chloride with Halal and Kosher certifications, catering to global markets[5]. Indian exporters like Jatan Exports provide cost-effective alternatives, though buyers must verify compliance with USP/BP standards[14].
Integration in Combination Products
The Suflave formulation includes potassium chloride (1.12 g/dose) to prevent electrolyte imbalance during bowel preparation[16]. Suppliers must coordinate with drug manufacturers to optimize dissolution profiles, ensuring rapid electrolyte release without compromising stability.
Sodium Chloride: API Suppliers and Global Distribution
Leading Manufacturers and Certifications
Sodium chloride, a ubiquitous API in IV fluids, is produced by Pharm-RX Chemical Corporation under cGMP, with NSF and USDA approvals for dietary and pharmaceutical use[5]. Jatan Exports (India) supplies USP/BP-grade sodium chloride, emphasizing rapid delivery (7–21 days) and end-to-end documentation support[14]. Cargill, Inc., a bulk supplier, integrates sodium chloride into animal health and food products, highlighting cross-industry versatility[5].
Applications in Parenteral Nutrition
As a component of Suflave (0.5 g/dose), sodium chloride ensures isotonicity, preventing cellular dehydration during colonoscopy preparation[16]. Suppliers must adhere to endotoxin limits (<0.5 EU/mg) for injectable grades, necessitating advanced purification techniques.
Sodium Sulfate: Regulatory and Supply Chain Considerations
Supplier Profiles and Compliance
Sodium sulfate, used in bowel cleansers and diagnostic agents, is supplied by Braintree Laboratories under FDA-approved DMFs for products like Suflave[16]. MTC Industries distributes technical-grade sodium sulfate for agricultural and pharmaceutical applications, though GMP compliance remains a buyer responsibility[2].
Market Dynamics and Tariff Impacts
The U.S. tariff regime on Chinese chemical imports has shifted sourcing strategies, with companies like Catalynt Solutions expanding North American distribution networks to mitigate supply risks[1][6].
Conclusion: Strategic Supplier Selection in a Volatile Market
Pharmaceutical suppliers must balance regulatory compliance, geopolitical risks, and formulation-specific requirements. For magnesium sulfate, dual sourcing from U.S. and EU suppliers mitigates tariff-related disruptions. PEG 3350 formulators should partner with excipient specialists like BASF to optimize polymer characteristics. Potassium chloride and sodium chloride buyers benefit from Indian exporters’ cost efficiency but must prioritize batch testing. Sodium sulfate’s role in combination therapies necessitates stringent endotoxin controls.
As trade tensions and API demand evolve, suppliers with diversified production sites and robust quality systems will dominate the market.
Key Takeaways
- Regulatory certifications (GMP, USP, ISO) are critical for API suppliers.
- Geopolitical factors, such as U.S.-China tariffs, necessitate diversified sourcing.
- Combination therapies (e.g., Suflave) require precise electrolyte ratios, demanding tight supplier coordination.
- Emerging markets (e.g., India) offer cost-effective alternatives but require rigorous quality audits.
FAQs
Q1: How do tariffs impact magnesium sulfate pricing?
U.S. tariffs on Chinese imports have spurred preemptive stockpiling, increasing short-term demand and prices[1].
Q2: What certifications are essential for sodium chloride suppliers?
USP/BP grades, NSF/USDA approvals, and cGMP compliance ensure suitability for injectable formulations[5][14].
Q3: Which suppliers offer PEG 3350 with FDA DMFs?
Spectrum Chemical and Braintree Laboratories provide DMF-supported PEG 3350 for bowel preparation products[12][16].
Q4: How do combination therapies affect supplier selection?
Suppliers must demonstrate batch-to-batch consistency in API purity and particle size to maintain formulation efficacy[16].
Q5: Why is endotoxin control critical for sodium sulfate?
Endotoxins in parenteral-grade sodium sulfate can provoke immune reactions, necessitating stringent purification[16].
References
- https://www.chemanalyst.com/NewsAndDeals/NewsDetails/north-american-magnesium-sulphate-market-improves-in-january-2025-34569
- https://www.thomasnet.com/suppliers/usa/magnesium-sulfate-49462401
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/polyethylene-glycol-3350-electrolytes-3
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/potassium-chloride
- https://www.thomasnet.com/suppliers/usa/sodium-chloride-76121201
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/sodium-sulfate
- https://www.pharmaexcipients.com/excipient-suppliers-list/
- https://www.apisourcing.net/statistics/new-listed-api-manufacturers/
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/magnesium-sulfate
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/magnesium-sulfate
- https://pharmaoffer.com/api-excipient-supplier/magnesium-salts/magnesium-sulfate
- https://www.spectrumchemical.com/magnesium-sulfate-heptahydrate-usp-ep-5120407
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/potassium-chloride
- https://jatanexports.com/api/sodium-chloride/
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/magnesium-sulfate
- https://www.drugs.com/imprints/medicine-34696.html
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