Share This Page
Suppliers and packagers for generic pharmaceutical drug: ABALOPARATIDE
✉ Email this page to a colleague
ABALOPARATIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | NDA | Radius Health, Inc. | 70539-001-02 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-02) / 1.56 mL in 1 CARTRIDGE (70539-001-01) | 2017-05-01 |
| Radius | TYMLOS | abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | NDA | Radius Health, Inc. | 70539-001-98 | 1 CARTRIDGE in 1 BOX, UNIT-DOSE (70539-001-98) / 1.56 mL in 1 CARTRIDGE (70539-001-99) | 2017-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: ABALOPARATIDE
Introduction
Abaloparatide is an innovative synthetic peptide analog of parathyroid hormone-related protein (PTHrP), developed primarily for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Its mechanism involves stimulating bone formation and increasing bone mineral density (BMD). Marketed under the brand name Tymlos in the United States, abaloparatide's commercial success hinges on a robust supply chain, encompassing raw material providers, peptide synthesis manufacturers, and formulation specialists. This report systematically evaluates current and potential suppliers critical to the abaloparatide manufacturing process, ensuring comprehensive insight into the drug’s supply ecosystem.
Manufacturing Process Overview & Supply Chain Components
The production of abaloparatide involves several complex steps:
- Raw Material Procurement – sourcing high-purity amino acids and chemicals.
- Peptide Synthesis – solid-phase peptide synthesis (SPPS) and purification.
- Formulation & Packaging – final drug formulation, stability testing, and packaging.
Each stage requires specialized suppliers with stringent quality standards compliant with pharmaceutical regulations such as FDA, EMA, or ICH guidelines.
Raw Material Suppliers
The integrity of abaloparatide depends heavily on high-grade raw materials, primarily amino acids and solvents.
- Amino Acids: Suppliers like Ajinomoto and Cambridge Commodities are recognized for supplying pharmaceutical-grade amino acids, including those used in peptide synthesis. Ajinomoto, with a global footprint, offers cGMP-compliant amino acids critical for consistent peptide quality.
- Chemicals & Solvents: Companies such as Sigma-Aldrich (Merck) and VWR International provide sterile, pharmaceutical-grade solvents (e.g., DMF, DCM) necessary for peptide synthesis and purification.
Peptide Synthesis Manufacturers
The core of abaloparatide manufacturing lies in peptide synthesis, typically via solid-phase peptide synthesis (SPPS). Several specialized contract manufacturing organizations (CMOs) and major peptide producers are involved:
- Bachem: A Swiss-based biotech and CMO offering custom peptide synthesis with extensive experience in peptide-based therapeutics. Bachem’s facilities comply with cGMP standards, making it a key supplier for abaloparatide development and production.
- Polypeptide Group: Based in the UK, they supply GMP-grade peptides for clinical and commercial purposes, with capabilities in large-scale peptide manufacturing suitable for abaloparatide.
- CordenPharma (a division of Piramal Pharma Solutions): Provides peptide synthesis, purification, and formulation services with a focus on blockbuster biologics and peptides.
- Cytoglane: Known for producing high-quality peptides and offering peptide synthesis tailored to clinical and commercial needs.
Manufacturers like Peptide Novus and GenScript may also support early-phase development but are less likely to be involved in large-scale production.
Formulation and Final Drug Product Suppliers
Following peptide synthesis, formulation specialists ensure stability, bioavailability, and delivery of abaloparatide.
- Formulation Experts: Companies such as Catalent and Recipharm possess experience in developing injectable products, including peptide-based therapeutics.
- Packaging Providers: For injectables like abaloparatide, suppliers such as West Pharmaceutical Services or Nipro manufacture prefilled syringes and safety devices compliant with pharmaceutical standards.
Regulatory Considerations and Supplier Qualification
Given the stringent regulatory environment surrounding peptide therapeutics, supplier qualification is critical. Manufacturers must demonstrate compliance with cGMP, ISO certifications, and validated quality control (QC) processes.
- Supplier Audits and Qualification: Major pharmaceutical companies typically perform rigorous audits before establishing supply agreements.
- Consistency & Traceability: Ensuring batch-to-batch consistency and detailed traceability are non-negotiable, especially in peptide synthesis and raw material procurement.
Key Industry Players in Abaloparatide Supply Chain
| Supply Chain Segment | Leading Suppliers/Manufacturers | Specialization & Notes |
|---|---|---|
| Raw Material Suppliers | Ajinomoto, Sigma-Aldrich, VWR | High-purity amino acids and solvents, GMP-compliant |
| Peptide Synthesis | Bachem, Polypeptide Group, CordenPharma | cGMP-grade peptides, large-scale manufacturing |
| Formulation & Packaging | Catalent, Recipharm, West Pharmaceutical Services | Injectable formulations, prefilled syringes |
| Quality & Regulatory Compliance | Multiple global certification bodies | ISO, EU Good Manufacturing Practice (GMP), FDA inspections |
Emerging Suppliers and Strategic Considerations
The peptide therapeutics field is witnessing increased consolidation and partnerships. Companies like Polypeptide Group and CordenPharma are expanding capacities, seeking strategic alliances with biotech firms producing abaloparatide. Additionally, raw material suppliers are exploring sustainable and cost-optimized amino acid sourcing to meet growing demand.
Emerging suppliers in Asia, notably Suzhou Tianma and Jiangsu Hengrui, are seeking entry into the global peptide supply chain, though their regulatory compliance status remains under scrutiny for highly sensitive products like abaloparatide.
Supply Chain Challenges and Future Outlook
- Supply Consistency: The complex synthesis process affords vulnerability; disruptions in amino acid supply or peptide manufacturing can impact drug availability.
- Regulatory Scrutiny: Increasing international regulatory standards necessitate rigorous supplier qualification and ongoing monitoring.
- Cost Optimization: As demand surges, securing reliable, cost-effective sources is vital for maintaining profit margin and price competitiveness.
Looking forward, advancements in peptide manufacturing technologies, such as continuous flow synthesis and genetically engineered expression systems, could reshape supplier landscapes, potentially reducing costs and lead times.
Key Takeaways
- The supply chain for abaloparatide is highly specialized, involving high-quality raw materials, advanced peptide synthesis, and precise formulation.
- Leading manufacturers like Bachem and Polypeptide Group dominate peptide synthesis, with GMP certification paramount for large-scale production.
- Raw material providers such as Ajinomoto and Sigma-Aldrich are integral, offering pharmacopoeia-compliant amino acids.
- Strategic partnerships and supply chain resilience are critical amidst evolving regulatory demands and rising global demand.
- Future innovation in peptide manufacturing promises to reduce costs and expand supplier options, but rigorous qualification remains essential.
FAQs
1. Who are the primary suppliers for raw materials used in abaloparatide production?
Mainstream suppliers include Ajinomoto and Sigma-Aldrich, providing pharmaceutical-grade amino acids and solvents tested for compliance with cGMP standards.
2. Which companies are leading peptide synthesis for abaloparatide?
Bachem and Polypeptide Group are the predominant manufacturers with demonstrated capability to produce GMP-grade peptides at scale.
3. What are the regulatory requirements for abaloparatide suppliers?
Suppliers must adhere to cGMP, ISO certifications, and provide comprehensive quality assurance documentation to satisfy FDA, EMA, and other authorities.
4. Are there emerging suppliers in the abaloparatide supply chain?
Yes, firms in Asia such as Suzhou Tianma are expanding into peptide manufacturing, although they face regulatory hurdles before widespread adoption.
5. What are future trends affecting abaloparatide suppliers?
Technological advances in peptide synthesis and increased focus on supply chain resilience are expected to influence supplier selection and manufacturing strategies.
References
[1] "Abaloparatide (Tymlos) – FDA Summary," FDA, 2017.
[2] "Peptide Manufacturing Market," MarketsandMarkets, 2022.
[3] "Global Raw Material Suppliers," PharmSource, 2021.
[4] "Contract Development and Manufacturing Organizations—Peptide Synthesis," EvaluatePharma, 2022.
[5] "Regulatory Standards for Biologics and Peptides," ICH Guidelines, 2020.
More… ↓
