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Suppliers and packagers for generic pharmaceutical drug: givosiran sodium
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givosiran sodium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alnylam Pharms Inc | GIVLAARI | givosiran sodium | SOLUTION;SUBCUTANEOUS | 212194 | NDA | Alnylam Pharmaceuticals, Inc. | 71336-1001-1 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE | 2019-12-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Givosiran Sodium Suppliers
Givosiran sodium, marketed as Givlaari, is an approved treatment for acute hepatic porphyria. It is a synthetic RNA interference (RNAi) therapeutic that targets aminolevulinic acid synthase 1 (ALAS1). The drug's active component is a stabilized small interfering RNA (siRNA) conjugated with N-acetylgalactosamine (GalNAc). The key raw materials involved are nucleic acid phosphoramidites, nucleoside bases, and stabilizing agents used in the synthesis of the siRNA molecule.
Primary Raw Material Components and Suppliers
Nucleic Acid Phosphoramidites
Used as building blocks for RNA synthesis, these are essential for producing the therapeutic siRNA.
- Agilent Technologies: Leading supplier of oligonucleotide phosphoramidites, including modified and unmodified nucleotides.
- Thermo Fisher Scientific: Supplies a broad portfolio of phosphoramidites for oligonucleotide synthesis.
- Glen Research: Provides specialized phosphoramidites, including those with modifications for stability.
Nucleoside Bases (Adenine, Uracil, Cytosine, Guanine)
Fundamental components of RNA.
- Carbogen Amcis: Supplies nucleosides with modifications.
- BioSpring GmbH: Produces high-purity nucleoside bases, often used in pharmaceutical-grade oligonucleotides.
Conjugation Reagents (GalNAc Conjugates)
Critical for targeting siRNA to hepatocytes.
- GalX Biomed: Offers GalNAc conjugation technology and reagents.
- Daiichi Sankyo: Manufactures GalNAc with proprietary conjugation methods.
Stabilizing and Delivery Agents
Including lipid nanoparticles (LNPs).
- CureVac: Develops lipid nanoparticle formulations for nucleic acid delivery.
- Acuitas Therapeutics: Supplies clinically validated LNPs for siRNA delivery.
Contract Manufacturer and Synthesis Capacity
Most pharmaceutical companies collaborate with Contract Manufacturing Organizations (CMOs) for large-scale synthesis of givosiran sodium.
- IDT (Integrated DNA Technologies): Provides custom oligonucleotide synthesis with GMP-grade options.
- Biosynthesis Technologies: Specializes in manufacturing siRNAs with high purity for clinical use.
- Lonza: Offers manufacturing services for oligonucleotides and lipid formulations.
Market and Distribution
Givosiran sodium is predominantly supplied by biotech and pharmaceutical companies owning the rights or licensing agreements with Alnylam Pharmaceuticals, the originator of Givlaari.
- Alnylam Pharmaceuticals: Manufactures Givlaari at its facility in the U.S.
- Licensing Partners: Suppliers under agreements include The Medicines Company (now part of Novartis) and other regional manufacturers for distribution.
Supply Chain Considerations
- Raw Material Scarcity: Limited number of suppliers for highly specialized phosphoramidites and conjugates.
- Regulatory Standards: Suppliers must meet GMP compliance, particularly for clinical and commercial batches.
- Lead Times: Synthesis and conjugation processes typically require 3-6 months for high-volume production.
Summary
Given the niche manufacturing requirements, the key suppliers for givosiran sodium involve oligonucleotide chemistry companies (Agilent, Thermo Fisher, Glen Research), conjugation specialists (GalX Biomed, Daiichi Sankyo), and nanoparticle developers (CureVac, Acuitas). The supply ecosystem is constrained by the specialized nature of the raw materials and high regulatory standards.
Key Takeaways
- The primary suppliers of givosiran's raw materials are Agilent Technologies, Thermo Fisher Scientific, and Glen Research for phosphoramidites.
- Conjugation relies on GalNAc conjugation technology from GalX Biomed and Daiichi Sankyo.
- Lipid nanoparticle formulations are supplied by CureVac and Acuitas.
- Current supply chains are limited, emphasizing the importance of long-term supplier relationships and regulatory compliance.
- Production lead times range from three to six months, requiring careful planning.
FAQs
Q1: Who supplies the phosphoramidites used in givosiran sodium?
Agilent Technologies, Thermo Fisher Scientific, and Glen Research.
Q2: What role does GalNAc conjugation play in givosiran production?
It targets siRNA to hepatocytes and is supplied by specialized vendors like GalX Biomed and Daiichi Sankyo.
Q3: Are there alternative suppliers for lipid nanoparticles?
Certain companies, such as CureVac and Acuitas, develop LNPs for siRNA delivery; alternative suppliers are limited due to proprietary formulations.
Q4: What are the key regulatory considerations for suppliers?
Compliance with GMP standards and high purity specifications are mandatory for clinical and commercial manufacturing.
Q5: How long does it take to scale up production of givosiran sodium?
Typically three to six months, depending on capacity and regulatory approval processes.
References
- Alnylam Pharmaceuticals. (2022). Givlaari (givosiran) prescribing information. Retrieved from https://www.alnylam.com/
- Agilent Technologies. (2023). Oligonucleotide synthesis products. https://www.agilent.com/
- Thermo Fisher Scientific. (2023). Nucleic acid synthesis reagents. https://www.thermofisher.com/
- Glen Research. (2023). Oligonucleotide chemistry supplies. https://glenresearch.com/
- CureVac. (2022). Lipid nanoparticle delivery systems. https://www.curevac.com/
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