Bulk Pharmaceutical API Sources for CERIVASTATIN SODIUM

Bulk Pharmaceutical API Sources for CERIVASTATIN SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246554
NovoSeek		23663992
MolPort		MolPort-003-845-726

Bulk Active Pharmaceutical Ingredient (API) Sources for Cerivastatin Sodium

Last updated: July 29, 2025

Introduction

Cerivastatin sodium, a member of the statin class, was developed as a potent HMG-CoA reductase inhibitor used for lowering LDL cholesterol levels. Although withdrawn from the market due to safety concerns, it remains relevant in academic and generic pharmaceutical contexts. Reliable sourcing of bulk cerivastatin sodium API is critical for manufacturing, research, and development activities. This article examines the current landscape of suppliers, manufacturing considerations, and due diligence in sourcing cerivastatin sodium API globally.

Overview of Cerivastatin Sodium API

Cerivastatin sodium is chemically known as (3R,5R)-7-[(3R)-hydroxy-4-methoxy-6-methyl-2-oxo-2H-pyran-3-yl]-3,5-dihydroxyhept-6-enoic acid sodium salt. Its synthesis involves complex chemical processes requiring specialized expertise and robust quality controls to ensure purity, stability, and compliance with pharmaceutical standards.

Despite market withdrawal, cerivastatin sodium remains available through certain domestic and international chemical suppliers, primarily for research and analytical purposes. The sourcing process involves evaluating manufacturer reputation, quality assurances, regulatory compliance, and supply chain stability.

Global API Manufacturers and Suppliers of Cerivastatin Sodium

1. Contract Manufacturing Organizations (CMOs) and API Producers

Several established chemical manufacturers produce cerivastatin sodium API primarily for research and development:

• Smaller Specialty Chemical Suppliers: They often provide research-grade cerivastatin sodium, offering quantities from grams to kilograms. Examples include chemical suppliers such as Toronto Research Chemicals and Tocris Bioscience.

• Major API Producers: Larger pharmaceutical intermediates manufacturers may produce cerivastatin sodium under strict cGMP conditions, primarily for clients with regulatory approval pathways or for investigational use. However, these manufacturers are often private entities or subsidiaries of larger pharmaceutical corporations.

2. Asian Suppliers

The majority of bulk cerivastatin sodium is sourced from Asian chemical manufacturing hubs, notably China and India. These regions are known for their robust chemical production capabilities and cost-effective manufacturing:

• Chinese API Manufacturers: Several companies operate at scale, offering bulk cerivastatin sodium. Notable considerations include verifying GMP status and ISO certifications.

• Indian Chemical Suppliers: India possesses numerous API manufacturers capable of producing statin APIs, including cerivastatin sodium, often serving global clients under tight quality controls.

Examples of Asian Suppliers:

• Hunan Huatian Pharmaceutical Co., Ltd. – Claims to manufacture and supply statin APIs, including cerivastatin sodium, for research purposes.

• Awa Pharma Pvt. Ltd. – Reports production of various statins, including cerivastatin sodium, emphasizing quality for research use.

Note: Indian and Chinese suppliers may primarily focus on non-GMP or research-grade API, necessitating due diligence for any intended clinical or commercial use.

3. Western Suppliers

Western API manufacturers offering cerivastatin sodium are rarer, primarily due to market withdrawal and reduced demand. Some European and North American chemical suppliers provide research-grade cerivastatin sodium, often for laboratory or analytical purposes:

• Sigma-Aldrich (Merck): Historically supplied research chemicals, including statin compounds. They may offer cerivastatin sodium for research use only.

• Toronto Research Chemicals: Offers research-grade cerivastatin sodium within their chemical catalog.

4. Custom Synthesis and OEM Manufacturing

Clients requiring large quantities or specific purity standards may engage with custom synthesis specialists who can produce cerivastatin sodium APIs per bespoke specifications. Factors influencing this choice include:

• Regulatory Standards: Ensuring compliance with cGMP, GLP, or other relevant standards.

• Quality Assurance: Validation of purity >98%, residual solvents, and impurity profiles.

• Supply Chain Reliability: Long-term stability and batch-to-batch consistency.

Criteria for Selecting API Suppliers

Given the niche nature of cerivastatin sodium, sourcing decisions hinge on several pivotal parameters:

a. Regulatory Compliance and Certification

Supply from GMP-certified manufacturers is paramount if APIs are for preclinical, clinical, or commercial use. For research purposes, suppliers with ISO 9001 or equivalent certifications may suffice.

b. Quality and Purity Standards

High-quality APIs with purity above 98%, verified through HPLC or LC-MS analyses, reduce contamination risks and ensure experimental validity.

c. Documentation and Traceability

Complete Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and manufacturing process details are non-negotiable. Traceability ensures APIs meet pharmacopoeial standards.

d. Supply Chain Stability and Lead Times

Reliable suppliers with consistent production capacities mitigate risks of shortages, especially critical for ongoing research.

e. Cost and Availability

Cost-effective sourcing should be balanced with quality considerations. Bulk purchasing and long-term agreements can improve pricing and supply stability.

Considerations and Challenges in Sourcing Cerivastatin Sodium API

Regulatory Restrictions

Due to cerivastatin sodium's withdrawal from the market after safety issues, regulatory agencies may impose restrictions on its sale, particularly for clinical applications. Export and import controls should be verified with relevant authorities.

Quality Verification

Counterfeit and substandard producNotifyers pose risks. Conduct thorough vendor audits and validate purity via independent testing before procurement.

Intellectual Property and Legal Aspects

While cerivastatin sodium is off-patent, ensure procurement complies with all legal requirements and licensing agreements.

Market Volatility

Limited specialty demand impacts availability and pricing, potentially leading to supply shortages or price hikes.

Future Outlook and Alternatives

Although cerivastatin sodium is largely withdrawn for clinical use, ongoing research and biosimilar development sustain interest in sourcing this API. Alternatives include other statins like atorvastatin or rosuvastatin, which are more readily available and regulated.

For research purposes, suppliers offering custom synthesis and verified research-grade APIs continue to be valuable sources. The trend in sourcing involves prioritizing verified, high-quality APIs from reputable vendors, regardless of geographic origin.

Key Takeaways

• Sourcing bulk cerivastatin sodium API involves navigating a complex landscape of manufacturers primarily located in Asia, with some Western supply options available for research-grade materials.

• Due diligence in verifying supplier certifications, API purity, and documentation underpins procurement, especially for non-clinical uses.

• Market withdrawal and regulatory restrictions limit commercial availability; thus, most sourcing is oriented towards research rather than therapeutic applications.

• The choice of supplier should align with regulatory standards, quality assurance processes, and supply stability, with an emphasis on GMP compliance where applicable.

• Alternatives or newer statins may serve research or development functions, but cerivastatin sodium remains relevant for specific scientific inquiries or legacy studies.

FAQs

1. Is cerivastatin sodium available for commercial pharmaceutical manufacturing today?
No. Cerivastatin sodium was withdrawn from the market in 2001 due to safety concerns. Its production is generally limited to research-grade supplies, and regulatory restrictions limit its use in ongoing pharmaceutical manufacturing.

2. What are the main criteria when choosing a supplier for cerivastatin sodium API?
Key criteria include GMP or equivalent certification, purity above 98%, comprehensive documentation (CoA, MSDS), supply stability, and compliance with safety and regulatory standards.

3. Can cerivastatin sodium be used for clinical trials now?
Using cerivastatin sodium in clinical trials faces regulatory hurdles because of its withdrawal and safety record. Such use may be restricted and require exceptional regulatory approval.

4. Are there reputable Asian manufacturers producing cerivastatin sodium?
Yes, several Chinese and Indian suppliers produce research-grade cerivastatin sodium. Nonetheless, verifying quality and certification remains essential.

5. Are there legal concerns with importing cerivastatin sodium?
Potential restrictions or licensing requirements depend on regional regulations. It is critical to verify import-export laws, especially related to controlled substances or discontinued drugs.

References

1. [1] U.S. Food and Drug Administration. Drug Recall Notices.
2. [2] Chinese National Medical Products Administration (NMPA) documentation on API production standards.
3. [3] European Medicines Agency (EMA) assessment reports for statins.
4. [4] Chemical supplier catalogs (e.g., Sigma-Aldrich, Toronto Research Chemicals).
5. [5] Market analysis reports on pharmaceutical API manufacturing.

(Note: Additional detailed source lists can be tailored based on specific supplier information or recent market datasheets.)