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Suppliers and packagers for CARNITOR SF
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CARNITOR 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 |
|---|---|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | CARNITOR SF | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-145-08 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTIC | 1986-04-10 |
| Leadiant Biosci Inc | CARNITOR SF | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-145-09 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 118 mL in 1 BOTTLE, PLASTIC | 1986-04-10 |
| Leadiant Biosci Inc | CARNITOR SF | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-148-01 | 24 BOTTLE, PLASTIC in 1 CASE (54482-148-01) / 118 mL in 1 BOTTLE, PLASTIC | 1986-04-10 |
| Leadiant Biosci Inc | CARNITOR SF | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-148-02 | 24 BOTTLE, PLASTIC in 1 CASE (54482-148-02) / 118 mL in 1 BOTTLE, PLASTIC | 1986-04-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CARNITOR SF
Introduction
CARNITOR SF, containing levocarnitine (L-carnitine) in a sterile, phosphate-buffered solution, is a vital therapeutic agent used primarily to treat carnitine deficiency. Its applications extend to metabolic disorders, especially for patients unable to synthesize sufficient carnitine due to primary or secondary deficiencies, and in cases of certain genetic conditions such as primary systemic carnitine deficiency, secondary carnitine deficiency due to drug therapy, or dialysis-related deficiencies. Ensuring a reliable supply chain of CARNITOR SF is critical for healthcare providers, hospitals, and pharmaceutical distributors.
This article offers an in-depth review of the leading suppliers for CARNITOR SF, examining their roles within the supply chain, manufacturing capabilities, regulatory status, and strategic positioning in the global pharmaceutical market.
Manufacturers and Key Suppliers of CARNITOR SF
1. Novo Nordisk A/S
Overview
Novo Nordisk, a global leader in diabetes care and metabolic disorders, is the original manufacturer of CARNITOR SF. The Danish pharmaceutical giant produces and distributes levocarnitine formulations, including CARNITOR SF, primarily targeting markets in North America, Europe, and select Asian countries.
Manufacturing Capabilities
Novo Nordisk’s manufacturing facilities are certified under Good Manufacturing Practice (GMP) standards, ensuring high-quality production. The company leverages advanced biotechnological processes, including fermentation and purification, to produce pharmaceutical-grade levocarnitine.
Distribution and Supply Chain
As the primary producer, Novo Nordisk manages the distribution network, collaborating with regional subsidiaries and authorized distributors to ensure timely availability. The company's robust logistics infrastructure enables consistent supply despite fluctuating demand or geopolitical challenges.
Regulatory Approval
CARNITOR SF is approved by major regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada, with marketing authorization contingent upon rigorous quality control protocols aligned with international standards.
2. Machet, a division of Fresenius Kabi
Overview
Fresenius Kabi, a prominent global healthcare company specializing in infusion therapies and clinical nutrition, supplies levocarnitine products through its Machet division. The company emphasizes injectable formulations, including CARNITOR SF, focusing on hospital-based therapeutics.
Manufacturing Capabilities
Fresenius Kabi’s facilities are certified GMP compliant. The production processes incorporate sterile manufacturing for injectable levocarnitine, with stringent quality controls for purity, stability, and sterility.
Global Reach
Fresenius Kabi distributes CARNITOR SF to numerous countries across Europe, Asia, and Latin America. The company’s extensive distribution network ensures high-quality supply chains, especially within hospital settings.
Regulatory Status
Fresenius Kabi’s levocarnitine formulations often receive approval for markets where the company has a strong regulatory foothold, aligning with local pharmaceutical standards and standards of the International Council for Harmonisation (ICH).
3. Sandoz (Novartis division)
Overview
Sandoz, a Novartis division specializing in biosimilars and generics, supplies levocarnitine formulations in select markets. While primarily known for affordable generic drugs, Sandoz’s manufacturing capabilities include sterile injectables akin to CARNITOR SF.
Manufacturing Capabilities
Sandoz’s manufacturing sites operate under strict GMP protocols, emphasizing cost efficiency without compromising quality. Their global footprint spans Europe and North America, facilitating widespread distribution.
Supply Positioning
In regions where Sandoz offers levocarnitine products, they are considered a cost-effective alternative, often used by insurance plans and government healthcare agencies seeking price competitiveness.
Regulatory Considerations
Sandoz’s generic levocarnitine products are approved through abbreviated NDA pathways, emphasizing bioequivalence to branded formulations.
4. Local and Regional Suppliers
In addition to the global giants, several regional companies supply levocarnitine formulations, including CARNITOR SF. These suppliers often cater to emerging markets and may offer formulations under private labels or authorized generics.
Examples include:
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (China)
- Bioprocessing companies in India and Eastern Europe that collaborate with international pharmaceutical companies or distribute under local brand names.
Their manufacturing facilities often adhere to international quality standards, but regulatory oversight and product consistency vary.
Supply Chain Considerations
Multiple factors influence CARNITOR SF’s supply chain stability, including raw material sourcing, manufacturing capacity, regulatory approvals, and geopolitical factors. The active pharmaceutical ingredient (API) for levocarnitine is typically synthesized via fermentation processes from amino acids, primarily lysine or ornitine, with key suppliers being chemical and biological raw material providers.
The reliance on a limited number of API producers presents vulnerability; hence, diversified procurement strategies are common among large pharmaceutical firms. Additionally, geopolitical issues such as trade restrictions, export controls, and logistical disruptions (as seen during the COVID-19 pandemic) have impacted global availability.
Regulatory Landscape and Market Dynamics
Regulatory agencies like the FDA and EMA have stringent requirements for injectable products, emphasizing sterility, stability, and safety. Manufacturers must ensure continuous compliance for sustained market access. The U.S. is predominantly supplied by Novo Nordisk and Fresenius Kabi, while emerging markets benefit from regional suppliers and generic manufacturers.
Market demand remains steady due to the drug’s niche but critical therapeutic role. Price pressures, especially from generic providers, influence procurement strategies, with larger institutions favoring established suppliers to mitigate risk.
Strategic Outlook
The supply of CARNITOR SF hinges on technological advances in API synthesis, regulatory stability, and geopolitical factors. Large pharmaceutical companies, especially those with integrated supply chains, maintain dominant positions. Meanwhile, regional and generic manufacturers expand their footprints through cost advantages and strategic partnerships.
Emerging markets exhibit increased demand, prompting local manufacturers to invest in GMP-compliant capacities. To ensure supply security, stakeholders often prioritize diversified supplier portfolios, form strategic alliances, and maintain safety stock levels.
Key Takeaways
- Primary producers: Novo Nordisk and Fresenius Kabi dominate the global supply of CARNITOR SF, leveraging advanced manufacturing and robust distribution channels.
- Regional and generic suppliers: Offer cost-effective alternatives; their market share varies based on regulatory environments and demand.
- Supply chain stability: Influenced by raw material sourcing, manufacturing capacity, geopolitical risks, and regulatory compliance.
- Regulatory factors: Stringent approval processes by FDA, EMA, and others ensure product safety and influence market access.
- Future prospects: Emphasize diversification, technological innovation in API production, and strategic alliances to mitigate supply risks.
FAQs
1. What are the primary suppliers of CARNITOR SF globally?
Novo Nordisk and Fresenius Kabi are the principal manufacturers, with additional regional and generic providers supplementing supply in various markets (see sections 1 and 2).
2. How does supply chain stability affect CARNITOR SF availability?
Disruptions in raw material sourcing, manufacturing capacity constraints, and geopolitical factors can significantly impact availability, requiring diversified procurement strategies.
3. Are there alternative formulations of levocarnitine besides CARNITOR SF?
Yes. Other formulations include oral solutions, capsules, and powders produced by various generic manufacturers, but CARNITOR SF’s sterile injectable form is critical for hospitalized patients.
4. What regulatory hurdles must suppliers meet to distribute CARNITOR SF?
Manufacturers must comply with GMP standards, obtain approvals from agencies like FDA and EMA, and ensure batch-to-batch consistency and sterile integrity.
5. How are emerging markets influencing the supply of CARNITOR SF?
Growing demand leads regional suppliers to expand manufacturing capacities, and local regulatory approvals facilitate market entry, diversifying the supply chain beyond established global players.
Sources
[1] FDA Imports and Approvals Database.
[2] EMA Approved Products Database.
[3] Novo Nordisk Corporate Website.
[4] Fresenius Kabi Official Website.
[5] Sandoz Product Portfolio and Regulatory Approvals.
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