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Suppliers and packagers for levocarnitine
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levocarnitine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Am Regent | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075861 | ANDA | American Regent, Inc. | 0517-1045-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01) | 2023-06-21 |
| Am Regent | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075861 | ANDA | American Regent, Inc. | 0517-1075-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2023-06-21 |
| Deva Holding As | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 217430 | ANDA | Devatis Inc. | 73043-034-05 | 5 VIAL in 1 CARTON (73043-034-05) / 5 mL in 1 VIAL | 2025-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Levocarnitine: Supplier Landscape and Procurement-Ready Shortlist
Who supplies levocarnitine at commercial scale?
Levocarnitine is supplied by a mix of ingredient specialists, bulk chemical producers, and branded API makers. The most procurement-relevant suppliers are the ones that publish manufacturing footprints (sites/countries), supply compliance documentation (GMP, DMF/CEP where applicable), and sell in API or intermediate form (bulk levocarnitine base, levocarnitine HCl, or related salt variants).
Below is a supplier shortlist structured for commercial sourcing and due diligence.
Procurement-ready supplier categories
| Category | Typical offering | How procurement evaluates fit |
|---|---|---|
| API producers (levocarnitine base / HCl) | Bulk API and/or grades for pharmaceutical formulation | GMP status, ability to support DMF/CEP, CoA and stability packages |
| Multi-purpose chemical distributors | Branded bulk or relabeled API | Traceability, change control, source-of-supply transparency |
| Contract manufacturers (custom salts / particle control) | Specific salt forms, custom specs | Batch record access, analytics, and regulatory support |
Which specific suppliers sell levocarnitine (API and salts)?
The following companies are established suppliers in the levocarnitine value chain and are consistently referenced in global commerce listings and/or supplier catalogs for pharmaceutical-grade levocarnitine and related salts.
Supplier shortlist (global)
| Supplier | Common product forms seen in market | Typical customer fit |
|---|---|---|
| Sigma-Aldrich / Merck | Levocarnitine and levocarnitine-related standards/salts (varies by SKU) | Research and pilot procurement; traceability via established catalog channel |
| TCI Chemicals | Levocarnitine and derivatives (catalog availability varies) | Lab-to-pilot purchases; not always regulated API supply |
| Cayman Chemical | Levocarnitine (research-use catalog) | Screening and lab scale |
| Alfa Aesar (Thermo Fisher Scientific) | Levocarnitine (catalog availability varies) | Lab and intermediate scale |
| CordenPharma (via chemical development and manufacturing ecosystem) | Carnitine-related intermediates and GMP services (site-dependent) | GMP outsource pathway where contract manufacturing is used |
Supplier shortlist (ingredient manufacturers and API-oriented firms)
| Supplier | Market role | What to confirm in procurement |
|---|---|---|
| Lonza | Large-scale API and chemical manufacturing ecosystem | Whether the specific levocarnitine grade is offered as a finished API versus a service |
| Fujifilm Wako | Chemical supplier with pharmaceutical-adjacent sourcing | Whether product is API-grade with regulatory support |
| Zhejiang NHU / related CN suppliers (China-based ingredient makers) | Bulk ingredient manufacturing | GMP status, DMF/CEP support, and import documentation |
Which suppliers are most relevant for pharmaceutical-grade procurement (vs research-grade)?
For pharmaceutical manufacturing inputs, procurement usually restricts the approved vendor universe to suppliers that can support at least one of the following:
- GMP manufacturing at a named site
- Regulatory dossier support (DMF for US filings, CEP for EU)
- Batch release documentation (CoA, analytics, stability protocol)
In practical procurement terms:
- Catalog suppliers (research-grade heavy) can be acceptable for development but typically do not meet commercial API dossier and audit requirements.
- API-focused or dossier-supporting manufacturers are preferred for commercial supply continuity.
How to structure an RFP for levocarnitine suppliers
The fastest path to supplier qualification is to RFP against a fixed specification and compliance package. Use a two-step request: (1) technical and regulatory snapshot, (2) quality and supply proof.
Technical package to require
- Salt form: levocarnitine base vs levocarnitine hydrochloride (levocarnitine HCl)
- Assay and impurity profile: define acceptance limits by your internal spec
- Particle and polymorph controls (if relevant for formulation performance)
- Stability data: forced degradation approach and shelf-life support
Regulatory and quality package to require
- GMP certificate for the manufacturing site(s)
- DMF or CEP status (where required for your filings)
- Quality agreement readiness and audit access
- Change control policy and notification timeline
- CoA template and batch traceability approach
Market procurement notes that affect supplier selection
Salt form drives supplier match
Levocarnitine is sold in different chemical forms, and procurement should not assume cross-compatibility:
- Levocarnitine base vs levocarnitine HCl can change:
- intake strength per gram,
- dissolution behavior,
- impurity burden.
Supplier responsiveness depends on grade stratification
Many suppliers carry both:
- research-grade bulk (fast lead times, minimal regulatory paperwork), and
- pharmaceutical-grade API (slower lead times, formal QMS, dossier linkage).
Qualification gates should be set to avoid mismatches.
Supplier due-diligence checklist (audit points)
Procurement teams typically confirm:
- manufacturing route and control strategy,
- solvent and catalyst residual controls,
- impurity identification method and update policy,
- endotoxin/bioburden position if your use case touches sterile processing,
- incoming material controls for intermediates (if levocarnitine is produced via intermediates).
Key Takeaways
- Levocarnitine sourcing spans research-grade catalog suppliers and API-focused manufacturers; pharmaceutical procurement should weight vendors that can supply GMP + dossier support.
- Salt form (base vs levocarnitine HCl) is a primary supplier fit discriminator and can affect dose-equivalence, impurity profile, and formulation behavior.
- A procurement-ready RFP should lock technical specs first, then demand dossier-grade documentation, CoA templates, change control, and audit access.
FAQs
-
Is levocarnitine typically sourced as the base or as levocarnitine HCl?
Both are used in the market; which one you should buy depends on your formulation strength calculations and regulatory spec for your product. -
Which suppliers are best for commercial API supply vs lab-grade purchasing?
Commercial supply usually requires GMP and dossier support; many catalog chemical suppliers are optimized for research-grade orders. -
What documents matter most when qualifying a levocarnitine supplier?
GMP certificate, CoA/analytics package, and dossier support (DMF/CEP where needed), plus change control and audit access. -
Does impurity profiling differ materially across suppliers?
Yes. Impurity control depends on the synthetic route, raw material controls, and purification steps, so acceptance limits should be vendor-qualified. -
What is the fastest way to reduce supplier qualification cycles?
Issue an RFP with locked specification targets and require dossier-grade documentation up front, then run documentation review in parallel with an on-site audit request.
References
[1] Merck. Levocarnitine (products and product documentation). Sigma-Aldrich/Merck catalog.
[2] TCI Chemicals. Levocarnitine (product listings and specifications). TCI catalog.
[3] Cayman Chemical. Levocarnitine (product listing). Cayman Chemical catalog.
[4] Thermo Fisher Scientific. Alfa Aesar levocarnitine (product listing). Alfa Aesar/Thermo Fisher catalog.
[5] Lonza. GMP manufacturing and API/chemical services overview (site-dependent offerings). Lonza corporate information.
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