Suppliers and packagers for MULTIPLE VITAMINS INJECTION PEDIATRIC

MULTIPLE VITAMINS INJECTION PEDIATRIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	MULTIPLE VITAMINS INJECTION PEDIATRIC	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	210671	ANDA	Apotex Corp.	60505-6190-0	1 KIT in 1 CARTON (60505-6190-0) * 4 mL in 1 VIAL (60505-6297-1) * 1 mL in 1 VIAL (60505-6298-2)	2026-06-24

Suppliers and packagers for MULTIPLE VITAMINS INJECTION PEDIATRIC

Last updated: July 1, 2026

Suppliers for Multiple Vitamins Injection (Pediatric)

Multiple Vitamins Injection (pediatric) suppliers are largely determined by the product’s labeling (pediatric vs. adult), strength (e.g., with or without specific micronutrients), and the dosage form (single-dose vial vs. multi-dose container). In the U.S., supply typically comes from injectable-drug manufacturers that hold FDA approvals for the specific NDC strength and container configuration and, when applicable, manufacture under contract for the listed NDA/ANDA holder.

Who manufactures Multiple Vitamins Injection for pediatric use in the U.S.?

Primary manufacturers are the FDA-approved NDA holders and their contract manufacturers for the labeled product(s) sold under “Multiple Vitamins Injection” with pediatric labeling and pediatric dosing guidance. The supplier set is best defined at the NDC level (strength + container) because multiple strengths and pack configurations can have different manufacturing sites and, sometimes, different label holders.

How supplier lists differ by NDC strength and container

Key reasons the “supplier” differs across markets:

• Different strengths (e.g., varying amounts of water-soluble vs. fat-soluble vitamins).
• Different container sizes (single-dose vial vs. multi-dose container).
• Different markets (U.S. vs. EU vs. other geographies can have different manufacturing authorization chains).
• Different label holders (the marketing authorization holder may not be the manufacturer).

What to map to identify the true supplier

For procurement, litigation, or regulatory risk review, the supplier should be mapped as:

• NDA holder/labeler (U.S. labeler)
• NDC-to-manufacturer mapping (from FDA/Orange Book and label package insert manufacturing section where available)
• Manufacturing sites (site address listed in regulatory submissions or label)
• Contract manufacturing arrangements (when the labeler differs from the manufacturer)

What is the FDA approval status of pediatric Multiple Vitamins Injection?

The FDA approval status is tied to the specific NDC and whether it is an NDA (or, less commonly, an ANDA if applicable). Injectable vitamin combinations are often marketed as approved products with defined manufacturing processes and stability specifications.

Is it an Orange Book product with patent listings?

Many vitamin injection products are marketed without patent-listed protection in the Orange Book. When patents are listed, the Orange Book typically ties to:

• Specific formulations or concentration ranges
• Specific manufacturing/sterilization approaches
• Stability claims that support shelf-life

How FDA status affects supply reliability

• If there are multiple approved NDCs from different manufacturers, supply risk is lower.
• If there is one approved manufacturer for a pediatric NDC, shortages are more likely to impact pediatric hospital formularies.

Which suppliers have the approval for each pediatric NDC strength configuration?

Supplier eligibility is NDC-specific. A complete supplier list is produced by enumerating:

• The pediatric-labeled “Multiple Vitamins Injection” NDCs
• The labeler associated with each NDC
• The manufacturing site(s) named on the FDA-approved labeling and associated manufacturing record entries

How many suppliers typically cover pediatric Multiple Vitamins Injection?

Supplier count depends on:

• Whether the product has multiple ANDAs/NDA holders across strengths
• Whether there are parallel labelers sourcing from different contract manufacturers
• Whether the product is subject to active supply disruptions

In practice, injectable vitamin combination products often have a limited supplier base compared with oral vitamin products because sterile manufacturing capacity and batch release testing are specialized.

What generic entry risks exist for pediatric Multiple Vitamins Injection?

The main generic entry risk is not “patent challenge” alone but regulatory and manufacturing practicality for sterile combination injectables. Risks include:

• Limited capability for sterile manufacturing of combination vitamin solutions
• Stability and compatibility challenges (container closure system, light sensitivity, oxidation)
• Batch release testing requirements for multiple active components

Paragraph IV and litigation risk

Where an Orange Book patent exists, generic entrants may file Paragraph IV. For many injectable vitamin combinations, patent listings may be absent or narrow, shifting the risk from litigation to manufacturing readiness and regulatory approval timelines.

Which patent estates could limit supply for pediatric Multiple Vitamins Injection?

Supplier continuity can be affected by:

• Formulation patents covering vitamin concentrations and ratios
• Manufacturing method patents (e.g., stabilization and sterile filtration/terminal sterilization steps)
• Stability and shelf-life patents tied to container and storage conditions
• Use patents (less common for a basic vitamin injection but possible if tied to pediatric indication language)

How to evaluate whether patents affect supplier entry

For each NDC:

1. Check Orange Book for listed patents tied to that product
2. Identify expiration dates
3. Identify whether any Paragraph IV certifications exist (when available)
4. Assess whether the generic’s proposed formulation matches the protected concentration range

What formulation variants matter for pediatric Multiple Vitamins Injection supply?

Pediatric injectable vitamin products are commonly separated by:

• Water-soluble vitamin sets
• Fat-soluble vitamin inclusion
• Trace element inclusion or exclusion (in some lines, “multiple vitamins” may be bundled with other micronutrients under different naming conventions)
• Electrolyte or excipient differences that affect compatibility with TPN or infusion workflows

Supply implication

Even if two products both say “multiple vitamins injection,” the exact vitamin composition, excipients, and container system can prevent direct substitution in pediatric settings.

Who are the downstream purchasers most impacted by supplier constraints?

The primary buyers that feel supply constraints:

• Children’s hospitals
• NICUs and pediatric critical care pharmacies
• TPN compounding programs that require reliable vitamin component supply
• Home infusion and specialty pediatric infusion providers (if product is used in that workflow)

What does the competitive landscape look like for pediatric Multiple Vitamins Injection?

Competitive pressure is usually driven by:

• Availability of sterile injectable manufacturing slots
• Ability to maintain consistent specification compliance (vitamin assay potency, degradation products, sterility)
• Lead times for packaging components (vials, stoppers) and sterile filtration/terminal sterilization capacity

How should procurement teams verify the right supplier for pediatric Multiple Vitamins Injection?

High-confidence procurement verification requires:

• Mapping the exact NDC for the pediatric-labeled product and strength
• Confirming the labeler and the named manufacturer on the package insert or product labeling
• Checking current FDA listing status and label manufacturing site statements
• Verifying batch release history and lot-to-lot consistency for vitamin potency and stability

Key Takeaways

• “Multiple Vitamins Injection (pediatric)” suppliers are determined at the NDC strength and container configuration level, not by the generic name alone.
• In the U.S., reliable supplier identification requires linking labeler/NDA holder to the manufacturing site named on approved labeling.
• Patent-based entry limits may exist only for specific formulation or manufacturing protections and are best evaluated through the Orange Book by NDC.
• The biggest practical constraint for supply is typically sterile combination injectable manufacturing capacity and stability control, not only exclusivity.

FAQs

1) How do I identify the manufacturer of a pediatric “Multiple Vitamins Injection” from the NDC?

Use the product’s exact NDC and match it to the labeler/manufacturer statements in the FDA-approved labeling and listings for that NDC.

2) Are all “Multiple Vitamins Injection” products interchangeable for pediatric use?

No. Interchangeability depends on exact vitamin composition, concentrations, excipients, and container closure system, which vary by NDC.

3) Is pediatric Multiple Vitamins Injection generally protected by Orange Book patents?

Often it is either not listed or only narrowly protected for specific formulation or manufacturing aspects, but this must be verified per NDC via the Orange Book.

4) What manufacturing risks most often cause shortages for injectable vitamin combinations?

Sterile manufacturing capacity constraints, stability and degradation control, and packaging component availability typically drive disruptions.

5) Do generic versions require Paragraph IV certifications for this product category?

Where Orange Book patents are listed, a generic applicant may certify under Paragraph IV. Otherwise, entry is primarily governed by regulatory approval and manufacturing readiness.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drug Registration and Listing System (DRLS). (Accessed 2026).
3. FDA. Labeling and Prescribing Information (package insert) for approved products. (Accessed 2026).