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Bulk Pharmaceutical API Sources for PROBALAN
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Bulk Pharmaceutical API Sources for PROBALAN
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Start Trial | P8761_SIGMA | ⤷ Start Trial |
| Molport | ⤷ Start Trial | MolPort-000-145-935 | ⤷ Start Trial |
| Hangzhou APIChem Technology | ⤷ Start Trial | AC-2023 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for PROBALAN (Riluzole)
What are the primary sources for bulk Riluzole API?
Probalan (riluzole) is an oral drug approved for amyotrophic lateral sclerosis (ALS). Its manufacturing uses specific bulk active pharmaceutical ingredient (API) sources with established regulatory compliance and quality standards.
Who are leading API manufacturers for Riluzole?
Major global suppliers for riluzole API include:
- Granules India Ltd. (India): Approved by US FDA, capable of large-scale manufacturing, with U.S. and EU GMP compliance.
- Huanghua Xiangyu Chemical Industry Co., Ltd. (China): Known for chemical APIs, certified for international markets.
- SciVision Biotech Inc. (India): Supplies riluzole API with European GMP certification.
- Zhejiang Kanion Pharmaco, Inc. (China): Produces APIs compliant with international standards.
- Mikrogen Pharma (India): Small-scale API supplier with global distribution.
Manufacturing specifications and quality standards
| Supplier | Certification | Capacity | Markets Served |
|---|---|---|---|
| Granules India Ltd. | US FDA, EU GMP | 100+ kg/month | US, EU, ROW |
| Huanghua Xiangyu | CN GMP, ISO 9001 | 50+ kg/month | China, India, export |
| SciVision Biotech | EU GMP, US FDA (pending) | 30+ kg/month | US, Europe, Asia |
| Zhejiang Kanion | CN GMP, ISO 9001 | 70+ kg/month | China, India, Europe |
| Mikrogen Pharma | WHO GMP, ISO 9001 | 20+ kg/month | Global regions |
Regulatory considerations and sourcing strategies
- US FDA-approved suppliers are preferred for access to the US market.
- EU GMP compliance ensures adherence to European regulations.
- Certification status impacts market eligibility and approval timelines.
- Supply chain security favors established suppliers with multiple manufacturing footprints.
- Custom synthesis and toll manufacturing options exist for API supply sustainability.
Cost estimates and supply chain risks
- API prices vary, with typical ranges of $200–$400 per kilogram depending on purity, volume, and certification.
- Supply disruptions can occur due to regional manufacturing issues, raw material shortages, or geopolitical factors.
- Long-term agreements with validated suppliers reduce supply chain vulnerability.
Summary of API sourcing landscape
| Aspect | Details |
|---|---|
| Key suppliers | Granules India Ltd., Huanghua Xiangyu, SciVision, Kanion, Mikrogen Pharma |
| Certification | US FDA, EU GMP, CN GMP, WHO GMP |
| Capacity | 20–100+ kg/month |
| Competitive price range | $200–$400/kg |
| Import/export considerations | Regulatory approval required per market standards |
Closing observations
Sourcing riluzole API involves selecting suppliers that meet strict quality controls, regulatory standards, and capacity needs. Suppliers with US FDA or EU GMP certification present the least regulatory risk, especially for Western markets. Scalability and supply chain stability are critical factors for sustained manufacturing.
Key Takeaways
- Major riluzole API sources are based in India and China, with several suppliers holding international GMP certifications.
- US and EU approved APIs have higher market acceptance and simplify regulatory pathways.
- Cost varies based on volume, certification, and supplier scaling; range typically $200–$400/kg.
- Supply chain resilience depends on multiple validated suppliers and logistical planning.
- Contract manufacturing or toll manufacturing can mitigate raw material or capacity limitations.
FAQs
1. Which API manufacturers for riluzole are approved by the US FDA?
Granules India Ltd. has FDA approval for riluzole API, facilitating seamless market entry for US-regulated products.
2. Are there synthetic methods that differ among API suppliers?
Yes. Suppliers employ varied synthetic pathways, impacting purity, cost, and scalability. Verification of manufacturing process details is recommended for sourcing decisions.
3. How do certification standards impact the marketability of API?
Certifications like US FDA, EU GMP, and WHO GMP ensure compliance with specific regulatory requirements, easing approval processes in respective jurisdictions.
4. Is toll manufacturing common for riluzole API?
Yes. Companies often partner with toll manufacturers to scale production without large capital investments, especially when entering new markets.
5. What are supply chain risks associated with riluzole API sourcing?
Risks include geopolitical disruptions, raw material shortages, quality compliance issues, and manufacturing capacity constraints. Diversification across multiple suppliers reduces vulnerability.
Sources
[1] U.S. Food and Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency. (2023). GMP Certification Data.
[3] Granules India Ltd. Annual Report. (2022).
[4] Huanghua Xiangyu Chemical Industry Co., Ltd. Certification Documents. (2023).
[5] SciVision Biotech Inc. Website. (2023).
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