Bulk Pharmaceutical API Sources for COVERA-HS

Bulk Pharmaceutical API Sources for COVERA-HS

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		YhTTB@@GL`JColdTtRRLbTURbrbRfVxdvnhHHjnjjh@bh@@@
NovoSeek		2520
ISpharm		I06-0063
MP Biomedicals		195545

Bulk Active Pharmaceutical Ingredient (API) Sources for COVERA-HS

Last updated: July 29, 2025

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Introduction

COVERA-HS (verapamil hydrochloride ER) is a prescription medication used primarily for managing hypertension and certain cardiac arrhythmias. As with many extended-release formulations, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is critical for ensuring efficacy, safety, regulatory compliance, and supply chain continuity. This report provides a comprehensive analysis of potential bulk API sources for verapamil hydrochloride ER (covering Covera-HS), emphasizing supplier capabilities, quality standards, regulatory considerations, and market trends.

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1. API Overview and Manufacturing Challenges

Verapamil hydrochloride is a first-generation calcium channel blocker with well-established pharmacodynamics. Its extended-release formulations require APIs with specific particle size, purity, and bioavailability characteristics. Challenges in sourcing include maintaining consistent API quality, controlling impurities, and ensuring compatibility with the extended-release matrix.

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2. Major API Manufacturers for Verapamil Hydrochloride

The supply chain for verapamil hydrochloride APIs primarily encompasses large domestic and international manufacturers with robust regulatory adherence, technological expertise, and manufacturing capacity. The key suppliers include:

a) Teva Pharmaceuticals

• Overview: A leading generics manufacturer with extensive API production capabilities globally, including verapamil hydrochloride.
• Capabilities: State-of-the-art manufacturing facilities compliant with cGMP standards, offering high-purity APIs suitable for ER formulations.
• Certifications: USFDA, EMA, TGA, and other regulatory bodies.
• Strengths: Proven track record in generic APIs, reliable supply chain, and advanced analytical testing.
• Market Position: One of the top API suppliers globally, with diversified manufacturing sites in Israel, India, and Europe.

b) Aurobindo Pharma

• Overview: An Indian pharmaceutical giant with significant API manufacturing capacity and a focus on cardiovascular APIs.
• Capabilities: Offers high-quality verapamil hydrochloride APIs, with consistent batch quality suitable for extended-release formulations.
• Certifications: USFDA, WHO-GMP, EMA-approved plants.
• Strengths: Competitive pricing, robust supply chain, and regulatory track record.

c) Mylan (now part of Viatris)

• Overview: A major global player with a long-standing history in API manufacturing.
• Capabilities: Produces high-quality verapamil APIs meeting pharmacopoeial standards.
• Certifications: USFDA, EMA, and other global standards.
• Strengths: Extensive R&D pipeline and proven manufacturing expertise.

d) Yash Pharma, Hetero Labs, and Divi's Laboratories

• Overview: Leading Indian API manufacturers capable of supplying verapamil hydrochloride APIs.
• Capabilities: Focused on APIs with consistent quality standards, often serving both domestic and export markets.
• Strengths: Cost-effective production, scaling ability, and high regulatory compliance.

e) Chinese API Manufacturers (Zhejiang Hisoar Pharmaceutical, Zhejiang Kangle Pharmaceutical)

• Overview: Growing presence in the global API market.
• Capabilities: Capable of supplying bulk verapamil hydrochloride API cost-effectively.
• Quality Considerations: Require rigorous regulatory scrutiny to ensure compliance with international standards.

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3. Regulatory and Quality Standards

Sourcing APIs for a registered drug like Covera-HS demands comprehensive quality assurance. Suppliers must meet strict cGMP standards, with certification from regulatory authorities such as the USFDA or EMA. Many manufacturers adhere to Pharmacopoeial standards (USP, EP, JP), ensuring API purity, potency, and impurity limits are within acceptable limits.

Key quality considerations include:

• Impurity Control: Benchmarked against ICH Q3A and Q3B guidelines.
• Particle Size and Morphology: Critical for extended-release formulations.
• Stability Data: Ensuring API stability over shelf life.
• Analytical Validation: Robust testing for assay, impurities, residual solvents, and heavy metals.

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4. Supply Chain Dynamics and Market Trends

a) Increasing Demand from High-Quality Generics

The global push towards affordable cardiovascular medications has expanded API demand. Indian and Chinese manufacturers dominate, with India accounting for over 20% of the global API exports, driven by cost competitiveness and regulatory improvements[1].

b) Strategic Partnerships and Long-term Supply Agreements

Pharmaceutical companies often establish long-term supply agreements with trusted API manufacturers to mitigate risks associated with supply disruptions, quality issues, or regulatory hurdles.

c) Impact of Regulatory Changes

Stringent global regulations, especially in US and Europe, have prompted manufacturers to upgrade facilities and obtain certifications such as USFDA approval, ensuring continued access to these markets.

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5. Considerations for Sourcing API for Covera-HS

• Quality Assurance: Verify compliance with pharmacopoeial standards and regulatory approvals.
• Cost Efficiency: Balance pricing with quality standards; Indian API manufacturers are competitive.
• Supply Reliability: Prioritize suppliers with proven track records in on-time delivery.
• Regulatory Support: Choose suppliers with experience supporting regulatory submissions and audits.
• Technology Compatibility: Ensure API specifications meet the requirements for extended-release formulations, especially regarding particle size and impurity profile.

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Conclusion

Reliable bulk API sources for verapamil hydrochloride, the active ingredient in Covera-HS, predominantly include established Indian and global manufacturers, notably Teva, Aurobindo, Mylan, and Hetero. The choice of supplier hinges on strict adherence to quality standards, regulatory compliance, cost considerations, and supply chain robustness. As the cardiovascular API market continues to evolve, manufacturers must remain vigilant about regulatory developments and innovation in production processes to maintain supply continuity and product integrity for this vital therapeutic.

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Key Takeaways

• Leading API Suppliers: Teva, Aurobindo, Mylan, and select Chinese manufacturers are primary sources, with robust regulatory and quality credentials.
• Regulatory Compliance: Ensuring cGMP certification and adherence to pharmacopoeial standards is mandatory for API sourcing.
• Cost and Reliability Balance: Indian manufacturers offer competitive pricing and reliable supply, making them popular choices.
• Supply Chain Risks: Diversify suppliers and establish long-term partnerships to mitigate disruptions.
• Regulatory Landscape: Ongoing regulatory enforcement emphasizes the importance of validated manufacturing processes and comprehensive quality testing.

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FAQs

Q1: What are the primary factors to consider when choosing an API supplier for Covera-HS?
A1: Key considerations include regulatory compliance (USFDA, EMA), product quality and purity, manufacturing capacity, supply stability, cost competitiveness, and the supplier’s experience with ER formulations.

Q2: Are Chinese API manufacturers suitable sources for verapamil hydrochloride API for Covera-HS?
A2: Yes, but rigorous due diligence, including quality audits and certification verification, is essential to ensure compliance with international standards.

Q3: How does API purity impact the efficacy of Covera-HS?
A3: Impurities and inconsistent purity can alter pharmacokinetics, potentially reducing efficacy or increasing adverse effects. High-purity APIs are critical for predictable Extended-Release (ER) performance.

Q4: What role does regulatory approval play in API sourcing for cardiovascular drugs like Covera-HS?
A4: Regulatory approval by agencies like USFDA ensures that the API is manufactured under strict quality controls, supporting successful registration and market access.

Q5: How does supply chain diversification benefit pharmaceutical companies producing Covera-HS?
A5: It mitigates risks related to supplier-specific disruptions, regulatory issues, or geopolitical factors, ensuring uninterrupted production and market supply.

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References

[1] Parikh, P. (2021). “India’s API Industry: The Growth Story,” Pharmaceutical Manufacturing Review.