Suppliers and packagers for COREG

COREG

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297	NDA	Waylis Therapeutics LLC	80725-139-20	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)	2023-03-15
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297	NDA	Waylis Therapeutics LLC	80725-140-20	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-140-20)	2023-03-15
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297	NDA	Waylis Therapeutics LLC	80725-141-20	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-141-20)	2023-03-15
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297	NDA	Waylis Therapeutics LLC	80725-142-20	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-142-20)	2023-03-15

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: COREG

Introduction

COREG is the brand name for carvedilol, a non-selective beta-blocker with alpha-1 blocking activity, used primarily in treating hypertension, heart failure, and left ventricular dysfunction following myocardial infarction. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1995, COREG has become a widely prescribed medication within cardiovascular therapeutics. The manufacturing and distribution of carvedilol involve a complex supply chain comprising active pharmaceutical ingredient (API) suppliers, formulation firms, and distribution networks globally. This article explores the key suppliers involved in the COREG supply chain, highlighting market dynamics, major manufacturers, and implications for stakeholders.

Global API Manufacturers for Carvedilol

The foundation of the COREG supply chain rests on suppliers of carvedilol’s active pharmaceutical ingredient (API). Given the critical nature of the API's quality, safety, and efficacy, pharmaceutical companies source carvedilol from reputable, high-quality API manufacturers.

Major API Suppliers

1. Zhejiang Enhua Bio-Tech Co., Ltd. (China)
Zhejiang Enhua Bio-Tech is a significant API supplier in China, holding GMP certification and supplying carvedilol to global markets. The company's manufacturing facilities emphasize high-quality standards, making their APIs suitable for branded drugs like COREG.

2. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
A prominent Chinese manufacturer with extensive experience in cardiovascular APIs, Zhejiang Huahai supplies carvedilol to both generic and branded drug manufacturers. The company has a broad product portfolio and adheres to international regulatory standards, enhancing its competitiveness.

3. Shanghai Acebright Pharmaceuticals Corporation (China)
This Shanghai-based firm produces carvedilol API compliant with cGMP guidelines and supplies to international markets, including North America and Europe. Their capacity expansion aligns with growing global demand.

4. Teva Pharmaceutical Industries Ltd. (Israel)
While primarily a finished dosage form manufacturer, Teva also supplies high-quality APIs for carvedilol, sourced through a combination of in-house production and external suppliers. Teva's global footprint stabilizes supply chains and aligns with strict regulatory standards.

5. Aurobindo Pharma Ltd. (India)
A key Indian pharmaceutical manufacturer, Aurobindo supplies carvedilol API to the generics market and may serve branded formulations like COREG. The company's global regulatory status and manufacturing capacity enhance its role in the supply chain.

Formulation and Finished Dosage Manufacturing

Once the API is procured, the formulation of COREG tablets is conducted by specialized pharmaceutical manufacturing firms or authorized contract manufacturing organizations (CMOs).

Leading Manufacturers of COREG

• Pfizer Inc.
  As the original developer of COREG, Pfizer remains the primary marketing and distribution authority for the brand-name drug. Pfizer’s manufacturing network ensures quality control and global distribution capabilities.

• Contract Manufacturing Organizations (CMOs)
  Several CMOs globally produce COREG under license or contract for Pfizer or other authorized distributors. They adhere to stringent regulatory standards and often source APIs from reputed manufacturers like Zhejiang Enhua or Aurobindo.

• Generic Manufacturers
  Numerous generic companies produce carvedilol tablets following patent expirations. Notable firms include Zentiva, Teva, and Aurobindo, which supply carvedilol formulations to markets in North America, Europe, and emerging markets.

Distribution and Supply Chain Considerations

The distribution network of COREG spans multiple regions, necessitating reliable logistics and regulatory compliance. Major distributors and wholesalers such as McKesson, Cardinal Health, and Alliance Healthcare facilitate delivery to hospitals, pharmacies, and clinics.

The stability of the supply chain depends on sourcing APIs from certified manufacturers, efficient manufacturing processes, and adherence to Good Manufacturing Practices (GMP). Disruptions in API supply—due to geopolitical issues, manufacturing halts, or regulatory hurdles—can impact overall product availability.

Market Dynamics and Regulatory Impact

The global carveilol market is influenced by patent expirations (e.g., US patent expiration in 2018), leading to increased generic drug production. Providers seek cost-effective API sources from India and China, which account for a significant portion of global API manufacturing capacity.

Regulatory agencies such as the FDA, European Medicines Agency (EMA), and counterparts in other jurisdictions have stringent requirements that API suppliers must meet. Certification processes, audits, and compliance influence supplier selection and market access.

Future Outlook and Supply Chain Challenges

The landscape for COREG suppliers is evolving, driven by increased demand, regulatory scrutiny, and supply chain resilience initiatives. Companies are diversifying supply sources to mitigate risks associated with geopolitical tensions and global disruptions such as pandemics.

Advances in API manufacturing, including process improvements and quality assurance, bolster suppliers' roles. However, supply chain vulnerabilities remain, emphasizing the importance of robust supplier qualification programs and contingency planning.

Key Takeaways

• Primary API suppliers include Zhejiang Enhua, Zhejiang Huahai, and Aurobindo, primarily based in China and India, leveraging cost-effective manufacturing capabilities.
• Pfizer remains the core brand owner and oversees the formulary and distribution process, often collaborating with CMOs globally.
• Regulatory standards are pivotal; API suppliers must meet internationally recognized GMP certifications to ensure drug safety and efficacy.
• The generic carvedilol market has expanded, increasing reliance on Indian and Chinese manufacturers, with potential supply chain risks.
• Supply chain resilience is critical; stakeholders are actively engaging in diversification and quality assurance strategies amid geopolitical and logistical challenges.

FAQs

1. Who are the leading manufacturers of carvedilol API for COREG?
Major API producers include Zhejiang Enhua Bio-Tech, Zhejiang Huahai Pharmaceutical, Aurobindo Pharma, and Shanghai Acebright Pharmaceuticals, primarily in China and India, offering high-quality APIs for global markets.

2. How does regulatory compliance influence supplier selection for COREG?
Suppliers must meet GMP standards and obtain certifications from agencies like the FDA and EMA, ensuring APIs are safe, efficacious, and compliant with international regulations. Non-compliance can lead to manufacturing halts and supply disruptions.

3. Are there regional differences in COREG supply chains?
Yes. North American markets predominantly rely on APIs from Indian and Chinese manufacturers, with capacity dispersed among multiple suppliers. European markets require strict regulatory adherence, often favoring suppliers with approved or certified facilities.

4. How does patent expiration impact COREG’s supply chain?
Patent expiration has facilitated the entry of numerous generic manufacturers, increasing the demand for carvedilol APIs from cost-effective suppliers and expanding market access globally.

5. What are the risks associated with COREG’s supply chain?
Risks include geopolitical tensions, regulatory changes, manufacturing disruptions, and raw material shortages, particularly in China and India. Diversifying suppliers and strengthening quality assurance can mitigate these risks.

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References

1. U.S. Food and Drug Administration (FDA). Carvedilol NDA approval. 1995.
2. MarketsandMarkets. API Market Overview. 2022.
3. Pfizer Inc. COREG product information. 2023.
4. European Medicines Agency (EMA). API manufacturing guidelines. 2021.
5. Global API Manufacturing Trends. PharmTech, 2022.