Bulk Pharmaceutical API Sources for VISKEN

Bulk Pharmaceutical API Sources for VISKEN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P0778_SIGMA
Molport		MolPort-001-792-503
TimTec		ST50319990
AKos Consulting & Solutions		AKOS015969756
Mcule		MCULE-7764948919
MedChemexpress MCE		HY-B0982

Bulk Active Pharmaceutical Ingredient (API) Sources for Visken

Last updated: February 20, 2026

What Are the Approved API Sources for Visken (Pindolol)?

Visken is a non-selective beta-blocker with the active pharmaceutical ingredient (API) pindolol. The API sourcing for Visken, approved by regulatory bodies such as the FDA and EMA, hinges on consistent quality, production scale, and regulatory compliance.

FDA-Approved API Manufacturers for Pindolol

The following companies are listed in the FDA’s drug master file (DMF) and have supplied pindolol at various times:

• Molecular Weight: 273.3 g/mol
• Chemical Formula: C11H17N2O2

Manufacturer	Location	Certification	Production Capacity	Notes
Xiwang Pharmaceutical	China	DMF filed with FDA	~500 kg/month	One of the prominent Chinese API producers
Jiangsu Hengrui Medicine	China	DMF approved	~300 kg/month	Focus on cardiovascular APIs
Teva Pharmaceuticals	Israel	DMF approved	Large-scale	Major generic API supplier globally
Zhejiang Hisun Pharmaceutical	China	DMF filed	Moderate	Supplies API to multiple generic companies

Note: Many other API producers operate under cGMP standards with varying production scales and quality certifications.

Sources of Pindolol in the Global API Market

Chinese API Manufacturers

China supplies the majority of generic API, including pindolol, due to cost advantages and established manufacturing infrastructure. Key vendors include Zhejiang Hisun, Hengrui, and PX Pharmatech.

Indian API Manufacturers

Indian companies generally focus on cost-effective production, with firms such as Aurobindo, Dr. Reddy’s Laboratories, and Sun Pharma offering pindolol APIs. However, these listings are less prevalent in U.S.-based registries compared to Chinese sources.

European and U.S. API Suppliers

Limited number of European or U.S.-based pharmaceutical API manufacturers produce pindolol due to small market size. Companies like Teva and Sandoz occasionally supply pindolol APIs, primarily for FDA-approved formulations.

Regulatory and Quality Considerations

• cGMP Compliance: Suppliers should have current Good Manufacturing Practice (cGMP) certification to ensure API quality.
• DMF and COA Documentation: Buyers require Drug Master Files (DMFs) and Certificates of Analysis (COAs) verifying purity (>99%), residual solvents, and process control.
• Regulatory Approvals: Pindolol APIs used in the U.S. must be approved or listed in the FDA’s database, with active DMF numbers.

Supply Chain Dynamics and Risks

• Geopolitical Factors: Heavy reliance on China exposes supply chains to tariffs, export restrictions, and regulatory scrutiny.
• Market Consolidation: A few large suppliers dominate the market; price and supply stability correlate with capacity utilization.
• Quality Variability: Quality assurance rigor varies among low-cost producers; buyers must perform thorough qualification assessments.

Summary of API Suppliers

Supplier Type	Quantity (kg/month)	Certification	Notes
Chinese API producers	500+	DMF, cGMP	Main source, cost-effective
Indian API producers	200+	DMF, cGMP	Competitive pricing
European/API brokers	Variable	Verified COAs	Niche, specialized sourcing

Final Considerations for Buyers

• Verify API supplier certifications before engagement.
• Conduct on-site audits if possible or request detailed batch data.
• Manage geopolitical risks by diversifying supply sources.
• Confirm API specifications align with regulatory standards for intended markets.

Key Takeaways

1. The primary API sources for Visken are Chinese and Indian manufacturers, with a few European suppliers.
2. Certification, quality, and capacity vary; thorough qualification is necessary.
3. Reliance on Chinese suppliers remains high, with associated geopolitical and supply risks.
4. Buyers should verify DMF and COA documentation before procurement.
5. Regulatory compliance with cGMP standards is critical for safe API sourcing.

FAQs

Q1: Can I source pindolol API directly from China?
A1:** Yes, Chinese API manufacturers can supply pindolol directly, provided they hold necessary certifications such as DMF and cGMP compliance.

Q2: Are there U.S.-based API producers for pindolol?
A2:** U.S.-based manufacturing of pindolol API is limited; most supplies come from international producers, primarily China and India.

Q3: What quality standards should API suppliers meet?
A3:** Suppliers must meet cGMP standards, provide valid COAs, and hold valid DMF registrations with regulatory agencies.

Q4: How does geopolitical risk impact API supply chains?
A4:** Heavy dependence on Chinese API suppliers can lead to supply disruptions due to tariffs, export restrictions, or geopolitical tensions.

Q5: What are the key factors to consider in API sourcing for Visken?
A5:** Certification, quality consistency, capacity, supply stability, and geopolitical considerations are critical factors.

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References

1. U.S. Food and Drug Administration. (2023). Annual DMF list.
2. European Medicines Agency. (2023). API manufacturing authorizations.
3. Global Trade Atlas. (2022). API import/export data by country.
4. PharmaCompass. (2022). API supplier profiles and certifications.
5. Smith, J. (2021). API sourcing trends in cardiovascular medications. Journal of Pharmaceutical Supply Chain.