Suppliers and packagers for LEVOCARNITINE SF

LEVOCARNITINE SF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novitium Pharma	LEVOCARNITINE SF	levocarnitine	SOLUTION;ORAL	211676	ANDA	ANI Pharmaceuticals, Inc.	70954-139-10	118 mL in 1 BOTTLE (70954-139-10)	2019-08-14
Novitium Pharma	LEVOCARNITINE SF	levocarnitine	SOLUTION;ORAL	211676	ANDA	ANI Pharmaceuticals, Inc.	70954-140-10	118 mL in 1 BOTTLE (70954-140-10)	2019-08-14

Suppliers and packagers for LEVOCARNITINE SF

Last updated: June 4, 2026

Suppliers for LEVOCARNITINE SF (Levocarnitine) API, Intermediates, and Finished Dosage Forms

Executive summary: LEVOCARNITINE SF is supplied through a multi-tier pipeline: (1) levocarnitine API producers, (2) excipient and packaging vendors tied to commercial tablets or oral solutions, and (3) contract manufacturing organizations (CMOs) that formulate and package branded or private-label “SF” SKUs. Identifying “suppliers” in the strict sense requires mapping the specific LEVOCARNITINE SF product listing to its marketing authorization holder (MAH) and drug master file (DMF) and/or Orange Book/Swissmedic dossier linkages in the destination jurisdiction. With only the product name provided and no jurisdiction, dosage form, strength, or manufacturer/MAH, a complete and accurate supplier roster cannot be produced.

Which companies supply LEVOCARNITINE SF in the US, EU, and UK?

Direct answer: No jurisdiction-specific supplier list can be compiled from “LEVOCARNITINE SF” alone because supplier status depends on the labeled MAH, listed manufacturer sites, and dossier ownership (DMF/CEP chain).

What supplier identities change by market?

• Labeled MAH can differ from API manufacturer.
• Finished dosage fill-and-finish sites can be different from API manufacturing sites.
• “SF” suffix often denotes a product line or formulation variant, not a universal ingredient supplier designation.

What patents or regulatory dossiers determine who can supply LEVOCARNITINE SF?

Direct answer: Supplier qualification is constrained by regulatory documentation (DMFs/CEP, manufacturing authorizations, and dossier cross-references). Without the specific MAH and dossier identifiers for the LEVOCARNITINE SF SKU, patent and regulatory linkage cannot be mapped to named suppliers.

How dossiers map to suppliers

• API suppliers typically hold or reference a DMF (US) or hold CEP/DMF equivalents (EU).
• Finished dosage suppliers are the labeled manufacturer and batch-release/testing sites.

Is LEVOCARNITINE SF an API-only purchase or a finished-dose supply?

Direct answer: Both exist in the market, but “LEVOCARNITINE SF” does not specify whether the supply target is:

• levocarnitine API (bulk),
• an intermediate (carnitine-related starting material),
• a finished tablet/capsule/oral solution.

Typical supply chain segmentation

• API: levocarnitine crystallization, salt formation (commonly levocarnitine base; sometimes specific salts depend on label).
• Finished dose: blending, granulation (if solid), dissolution profile control, packaging validation.

What generic and contract manufacturing options exist for levocarnitine finished products?

Direct answer: Generic levocarnitine formulations are widely sourced, and CMOs are common, but supplier names must be tied to the destination label (MAH and manufacturing sites).

Commercially relevant product questions

• Is the product oral solution or solid oral dosage?
• Is it single-ingredient levocarnitine or combination?
• Does the “SF” line imply a specific grade (e.g., pharmaceutical vs. supplement)?

How does LEVOCARNITINE SF compare with levocarnitine products sold by other brands?

Direct answer: “LEVOCARNITINE SF” cannot be compared against other brands on a supplier basis without the labeled strength, dosage form, and MAH.

Supplier comparison factors

• API grade and polymorph control
• Salt form and specification set
• Excipients affecting stability and dissolution
• Packaging system (unit dose vs. multi-dose container)

What is the manufacturing and quality barrier for levocarnitine supply?

Direct answer: The key barriers are specification control, impurity profile, and GMP release at both API and finished-dose manufacturing.

Quality parameters that drive supplier qualification

• Impurities (process-related)
• Residual solvents (if synthetic route)
• Water content and polymorphism (for crystalline API)
• Stability under accelerated and long-term conditions
• Microbiological limits (finished dose)

Key Takeaways

• A precise supplier list for “LEVOCARNITINE SF” cannot be generated from the product name alone.
• Supplier identification requires linking the specific SKU to its MAH and the corresponding manufacturing site(s) or dossier references.
• Levocarnitine supply typically spans API and finished-dose manufacturing, with different entities owning different parts of the regulatory chain.

FAQs

1. How do I identify the real supplier behind a “brand” levocarnitine product label? Look up the MAH and the labeled manufacturing sites in the destination country’s product database and cross-reference dossier ownership (DMF/CEP).
2. Who typically manufactures levocarnitine API versus finished tablets or oral solutions? API is often made by specialized bulk manufacturers; finished-dose manufacturing is commonly done by MAH-owned plants or CMOs under contract.
3. Does “SF” on LEVOCARNITINE SF indicate a different API or strength? It usually indicates a product-line or configuration; it does not, by itself, establish the API supplier.
4. What determines whether a new supplier can enter the levocarnitine market for a specific label? Regulatory dossier referencing, GMP capability, and the ability to meet validated specifications and impurity/stability requirements for that exact formulation.
5. What documentation best links a levocarnitine finished product to its API supplier? Regulatory submissions that list DMF/CEP references and the API manufacturer(s) used for commercial batches.

References

1. (No sources were used.)