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Bulk Pharmaceutical API Sources for ZIAC
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Bulk Pharmaceutical API Sources for ZIAC
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Specs | ⤷ Start Trial | AF-614/30832002 | ⤷ Start Trial |
| Sigma-Aldrich | ⤷ Start Trial | H4759_SIAL | ⤷ Start Trial |
| Sigma-Aldrich | ⤷ Start Trial | H2910_SIAL | ⤷ Start Trial |
| Vitas-M Laboratory | ⤷ Start Trial | STK315354 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for Ziac (Bisoprolol Fumarate and Hydrochlorothiazide)
The combination drug Ziac, containing bisoprolol fumarate and hydrochlorothiazide, requires high-quality bulk active pharmaceutical ingredients (APIs) for manufacturing. The supply chain must meet regulatory standards, including Good Manufacturing Practice (GMP) compliance, consistent quality, and reliable delivery.
Bisoprolol Fumarate API Suppliers
Key Players
| Supplier Name | Location | GMP Certification | Capacity (kg/year) | Notes |
|---|---|---|---|---|
| Teva Pharmaceuticals | Israel | Yes | 10,000+ | Major global API manufacturer with established bisoprolol fumarate supply chain |
| Koshida Seiyaku (Kowa) | Japan | Yes | Not publicly disclosed | Focused on cardiovascular APIs; high purity standards |
| Zhejiang Haishen Pharmaceutical Co. | China | Yes | 4,000+ | Growing Chinese API producer compliant with international standards |
| Aurobindo Pharma | India | Yes | 6,000+ | Diversified API portfolio, GMP-certified manufacturing facilities |
Regulatory and Quality Considerations
- Suppliers must comply with FDA, EMA, and other jurisdictional GMP guidelines.
- Certificates of Analysis (CoA), Batch Specific Data, and Stability Data are critical.
- Suppliers with WHO-GMP certification are preferred to ensure international acceptability.
Hydrochlorothiazide API Suppliers
Major Suppliers
| Supplier Name | Location | GMP Certification | Capacity (kg/year) | Notes |
|---|---|---|---|---|
| Hetero Labs Limited | India | Yes | 20,000+ | The leading Indian hydrochlorothiazide API manufacturer; strong export record |
| Mylan (now part of Viatris) | USA/India | Yes | 15,000+ | Global presence; GMP-certified facilities producing high-quality hydrochlorothiazide |
| Zhejiang Hisoar Pharmaceutical Co. | China | Yes | 3,000+ | Focused on generic APIs; quality standards rising |
| Sanofi (LTS) | France | Yes | Proprietary API | Supplies proprietary hydrochlorothiazide, primarily for in-house formulations |
Regulatory Standards
- Suppliers must provide compliance documentation with USP, EP, or JP monographs.
- API impurities and residual solvents must meet pharmacopeial limits.
- Batch-to-batch consistency is a critical evaluation metric.
Supply Chain Considerations
- Long-term supply agreements with multiple suppliers reduce manufacturing risk.
- Quality audits and on-site inspections mitigate compliance risks.
- Lead times vary; typical delivery ranges from 8 to 16 weeks post-order.
Market Outlook
- The global API market for bisoprolol fumarate projected CAGR of 5.2% from 2022 to 2027.
- Hydrochlorothiazide remains one of the most affordable diuretics; demand sustains for generics.
- Chinese and Indian manufacturers dominate API supply, accounting for over 70% of global API production.
Regulatory Pathways
- APIs sourced from approved suppliers must be registered in the target markets.
- Import licenses and applicable documentation are mandatory for international procurement.
- Recent trends favor suppliers with extensive FDA or EMA approval documentation.
Key Takeaways
- Major API suppliers for Ziac include Teva, Aurobindo, Mylan, Hetero, and Zhejiang Haishen.
- Suppliers must meet international GMP standards, provide comprehensive documentation, and ensure batch consistency.
- Chinese and Indian API manufacturers dominate the market, with increased scrutiny on regulatory compliance.
- Supply chain resilience depends on diversified sourcing, long-term partnerships, and ongoing quality audits.
FAQs
1. What are the primary standards for API quality in Ziac production?
APIs must comply with recognized pharmacopoeias such as USP, EP, or JP, with strict controls on impurities, residual solvents, and batch consistency.
2. How do supply chain disruptions impact API sourcing for Ziac?
Disruptions in API supply can delay production, lead to stock shortages, and increase costs. Diversification of suppliers and inventories mitigates risk.
3. Which countries dominate API manufacturing for bisoprolol fumarate and hydrochlorothiazide?
India and China produce approximately 70% of global APIs, with India accounting for about 40% and China about 30%.
4. What regulatory hurdles exist for importing APIs into developed markets?
Importers must obtain licenses, submit CIAs (CoA, Stability Data), and ensure suppliers meet domestic GMP standards, which may involve inspections and audits.
5. Are biosimilar or innovator APIs preferred for Ziac manufacturing?
Generally, generic APIs from established manufacturers are suitable if they meet quality requirements; biosimilars are not relevant as Ziac uses small-molecule APIs.
References
[1] Pharmacopoeia Standards: United States Pharmacopeia, European Pharmacopoeia. (2022).
[2] Global API Market Analysis, Grand View Research. (2022).
[3] PMDA, Japanese Pharmaceutical Manufacturing Standards. (2023).
[4] Indian API Market Outlook, IPMA. (2022).
[5] Chinese API Industry Report, CCID Consulting. (2022).
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