Suppliers and packagers for SORBITOL-MANNITOL IN PLASTIC CONTAINER

SORBITOL-MANNITOL IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	SORBITOL-MANNITOL IN PLASTIC CONTAINER	mannitol; sorbitol	SOLUTION;IRRIGATION	018316	NDA	ICU Medical Inc.	0990-7981-08	4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG	2019-10-01

Suppliers and packagers for SORBITOL-MANNITOL IN PLASTIC CONTAINER

Last updated: June 6, 2026

Suppliers for Sorbitol-Mannitol in Plastic Container (Drug/Excipient Bulk + Contract Manufacturing)

Executive summary: The product name “Sorbitol-Mannitol in Plastic Container” maps to a class of polyol (sorbitol + mannitol) solutions used as pharmaceutical excipients and, in some markets, as an oral/enteral osmotic preparation component. Supplier coverage typically comes from three tiers: (1) raw-material manufacturers of sorbitol and mannitol, (2) solution blenders/fill-finish CMO/CDEs for plastic container formats, and (3) finished-product brands/labelers that control packaging, labeling, and regulatory dossiers. Without a specific market/strength (e.g., mg/mL or % w/v), package type (bag-in-bottle, bottle, IV bag), and regulatory status (US FDA drug vs excipient vs compendial), supplier lists cannot be produced accurately.

What companies supply sorbitol and mannitol raw materials for pharmaceuticals?

Most pharmaceutical procurement begins at the sorbitol and mannitol ingredient level. Common supplier categories include:

• Grade-qualified sorbitol producers (pharma-grade for oral/enteral use)
• Grade-qualified mannitol producers (pharma-grade for oral/enteral and sometimes injectable-grade, depending on quality system)
• Distributor networks that resell pharma-grade polyols with COAs and full documentation

How suppliers are typically selected (procurement criteria)

• GMP compliance and traceability from feedstock to API/excipient
• Specification alignment (identity, assay, residuals, microbial limits)
• Packaging compatibility for subsequent solution prep in plastics (extractables/leachables constraints)

Where do sorbitol and mannitol supply chains concentrate?

Supply concentrates in companies with:

• dedicated polyol production lines
• established pharma-quality documentation
• scale for kilogram-to-ton volumes

Which contract manufacturers fill sorbitol-mannitol solutions into plastic containers?

For “in plastic container” formats, supply usually shifts from ingredient suppliers to CMOs/CDMOs that can perform:

• blending (sorbitol + mannitol, water for injection or purified water depending on monograph)
• filtration (if required by the product spec)
• aseptic processing or terminal sterilization (depending on container and microbial strategy)
• filling into plastic (bottles, bags, or IV-style plastic containers) with controlled extractables

What container formats are typically used for polyol solutions in plastic?

Common plastic-container patterns in pharma include:

• polypropylene or polyethylene bottles
• IV-type flexible containers (solution bags) using multilayer films
• nested packaging with secondary cartons

Supplier qualification hinges on:

• extractables/leachables studies for the plastic film or closure system
• compatibility with the product’s pH, concentration, and presence/absence of electrolytes

What is the regulatory pathway for “sorbitol-mannitol in plastic container” as a drug or excipient?

This matters because it changes supplier eligibility, documentation, and who “counts” as a supplier.

Is it an FDA-regulated drug or a pharmaceutical excipient?

Two procurement realities exist:

• If the product is an excipient (polyol solution used in formulation or compounding), suppliers are often excipient manufacturers and distributors.
• If it is a marketed dosage form, suppliers include the finished-product manufacturer/labeler plus authorized manufacturing sites.

The same chemical inputs can appear in both contexts, but the compliance package differs.

How to map “plastic container” suppliers in practice (tiered sourcing map)

Tier 1: Raw materials

• Sorbitol supplier (pharma-grade)
• Mannitol supplier (pharma-grade)

Tier 2: Solution manufacturing / fill-finish

• Blender/sterile fill-finish sites
• Plastic container compatibility and leachables documentation

Tier 3: Finished product / labeler (if applicable)

• Brand or generic labeler
• Packaging and distribution entity

What supplier risks exist for polyol solutions in plastic (manufacturing/IP/quality)?

Supplier due diligence typically focuses on:

• Leachables from plastic and closure systems
• Lot-to-lot consistency of viscosity, osmolality, and microbial control
• Stability data for the exact container configuration

Key Takeaways

• “Sorbitol-mannitol in plastic container” sourcing usually spans polyol raw materials plus fill-finish into plastic.
• Supplier identification requires the exact strength, intended route (oral/enteral vs sterile parenteral), and container configuration to avoid mismatching excipient versus finished drug supply chains.
• The practical supplier set is structured into (1) sorbitol/mannitol ingredient manufacturers, (2) CMO/CDMOs capable of plastic fill-finish, (3) finished-product labelers if it is a marketed dosage form.

FAQs

1. Who qualifies as a supplier for sorbitol-mannitol when the product is an excipient versus a finished dosage form?
2. What quality documents are typically required** (COA specs, leachables/extractables, stability) for plastic-container polyol solutions?
3. How do container type choices (bag vs bottle, film multilayer vs monolayer) affect supplier selection for sorbitol-mannitol?
4. What manufacturing steps (filtration, sterilization, aseptic processing) change the eligibility of CMOs for polyol solutions?
5. What osmolality/viscosity targets drive formulation and stability requirements for sorbitol-mannitol solutions in plastic containers?

References

No sources were cited because no specific product database entry (strength, dosage form, NDC/UK/EP code, dossier) was provided to validate named suppliers.