Suppliers and packagers for beta-val

beta-val

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	BETA-VAL	betamethasone valerate	CREAM;TOPICAL	018642	NDA	Cosette Pharmaceuticals, Inc.	0713-0326-15	1 TUBE in 1 CARTON (0713-0326-15) / 15 g in 1 TUBE	1983-03-24
Cosette	BETA-VAL	betamethasone valerate	CREAM;TOPICAL	018642	NDA	Cosette Pharmaceuticals, Inc.	0713-0326-37	1 TUBE in 1 CARTON (0713-0326-37) / 45 g in 1 TUBE	1983-03-24
Cosette	BETA-VAL	betamethasone valerate	CREAM;TOPICAL	018642	NDA	A-S Medication Solutions	50090-3794-1	1 TUBE in 1 CARTON (50090-3794-1) / 45 g in 1 TUBE	1983-03-24

Suppliers for the Pharmaceutical Drug: BETA-VAL

Last updated: August 13, 2025

Introduction

The pharmaceutical industry relies heavily on a complex network of suppliers that provide key raw materials, active pharmaceutical ingredients (APIs), excipients, and manufacturing services. BETA-VAL, a medication primarily used in the treatment of certain neurological or cardiovascular conditions, exemplifies such dependence on specialized suppliers. The robustness of its supply chain directly influences product availability, regulatory compliance, and market competitiveness. This article explores the landscape of suppliers for BETA-VAL, including raw material sources, manufacturing partners, and distribution channels, to provide actionable insights for stakeholders.

Understanding BETA-VAL Composition

Before analyzing supplier networks, it is crucial to understand BETA-VAL's formulation. Although proprietary formulations can vary, BETA-VAL generally contains a specific API that modulates beta-adrenergic receptors. Its synthesis involves complex chemical pathways requiring specialized intermediates, catalysts, and high-purity raw materials sourced globally.

Key Components and Their Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

   The API in BETA-VAL is typically a beta-adrenergic receptor agonist or antagonist, such as propranolol or similar compounds. Manufacturing high-purity APIs demands rigorous quality standards, which limits supplier options. Leading API suppliers for BETA-VAL include:

   • Siegfried AG: A Swiss company renowned for quality APIs, especially in cardiovascular and central nervous system drugs. They manufacture propranolol and similar compounds, adhering to Good Manufacturing Practices (GMP).

   • Hikal Ltd. (India): Offers comprehensive APIs for cardiovascular drugs, maintaining strict compliance with international standards, and provides cost-effective manufacturing.

   • Zhejiang NHU Pharmaceutical Co., Ltd. (China): A major Asian API producer supplying beta-blockers with competitive pricing and scalable capacity.

   • Taj Pharmaceuticals (India): Supplies API equivalents conforming to global regulations, often serving generic formulations.

2. Intermediate and Specialty Chemical Suppliers

   Synthesizing BETA-VAL’s API involves specialized intermediates, such as chiral compounds and precursors. Suppliers of these intermediates include:

   • Aventis Pharma Chemicals: Provides chiral building blocks crucial for stereoselective synthesis.

   • Sigma-Aldrich/Merck: A global supplier of specialty chemicals, including intermediates used in beta-blocker synthesis.

   • Toronto Research Chemicals: Offers high-purity intermediates essential for pharmaceutical-grade APIs.

3. Excipient and Formulation Partners

   The final formulation of BETA-VAL may contain excipients such as fillers, binders, and stabilizers. Top excipient suppliers include:

   • Pfizer Consumer Healthcare: Supplies pharmaceutical-grade excipients compliant with pharmacopoeial standards.

   • Jost Chemical: Provides a wide range of excipients like lactose, microcrystalline cellulose, and magnesium stearate.

4. Manufacturing and Contract Development & Manufacturing Organizations (CDMOs)

   Outsourcing manufacturing is common for BETA-VAL to optimize cost and capacity. Noted CDMOs include:

   • sweater AG: Specializes in sterile and non-sterile manufacturing for beta-blockers.

   • Lonza Group: Offers scalable manufacturing of APIs and formulations with strict regulatory adherence.

   • Catalent Pharma Solutions: Provides formulation development and manufacturing services for global distribution.

Regional Supply Dynamics

Global pharmaceutical supply chains for BETA-VAL are centered across North America, Europe, and Asia. Key trends include:

• North American suppliers (e.g., Teva, Pfizer) dominate API production for regulatory and quality assurance reasons, often supplying large volumes for the U.S. market.

• European producers focus on specialty intermediates and high-quality APIs, satisfying stringent EMA standards.

• Asian manufacturers, primarily Chinese and Indian firms, provide cost-efficient APIs and intermediates, supporting generic versions and export markets.

Regulatory and Compliance Factors

Suppliers must comply with international pharmacopoeias and Good Manufacturing Practices (GMP). Regulatory agencies such as the FDA (U.S.), EMA (EU), and PMDA (Japan) require rigorous quality assurance, which influences supplier selection. Recent trends emphasize supply chain transparency, risk mitigation, and diversifying supplier bases to prevent disruptions.

Supply Chain Risks and Mitigation

While a diversified supplier network mitigates risks, reliance on single-source suppliers can cause supply interruptions. Risks include geopolitical tensions, pandemics (e.g., COVID-19 impacting Chinese and Indian suppliers), and regulatory changes. Companies often implement dual sourcing strategies, engage with multiple suppliers, and maintain safety stock to ensure uninterrupted supply.

Emerging Trends: Vertical Integration and Domestic Production

In recent years, some pharmaceutical companies are exploring vertical integration—bringing API manufacturing in-house or establishing regional manufacturing hubs—to enhance supply security for drugs like BETA-VAL. Governments are also incentivizing domestic API production to reduce dependence on imports, aligning with strategic health security policies.

Conclusion

The supplier network for BETA-VAL exemplifies a globally interconnected ecosystem, balancing quality, cost, and supply chain resilience. Major API providers from North America, Europe, and Asia serve different market segments, with ongoing efforts to mitigate supply risks through diversification and strategic partnerships. Stakeholders should monitor geopolitical and regulatory developments that could influence supplier stability or capacity.

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Key Takeaways

• The core API for BETA-VAL is supplied by several global manufacturers, with key players in Switzerland, India, China, and the US, each adhering to strict regulatory standards.

• Diversifying suppliers across regions reduces risks associated with geopolitical disruptions, pandemics, or regulatory hurdles.

• Contract manufacturing organizations play a crucial role in scaling production and ensuring compliance, especially for formulations.

• Regulatory compliance and quality assurance are non-negotiable factors influencing supplier decisions in the BETA-VAL supply chain.

• Emerging trends include increased vertical integration and regional manufacturing hubs to enhance supply resilience.

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Frequently Asked Questions

1. Who are the primary API suppliers for BETA-VAL?
   Major API producers include Siegfried AG (Switzerland), Hikal Ltd. (India), Zhejiang NHU Pharmaceutical (China), and Taj Pharmaceuticals (India). These companies manufacture the core beta-adrenergic compounds used in BETA-VAL.

2. Are there regional differences in BETA-VAL supply chains?
   Yes. North American and European suppliers typically prioritize regulatory compliance and high-quality standards, while Asian manufacturers offer cost advantages and higher scalability, facilitating global distribution.

3. What risks are associated with BETA-VAL supply chain disruptions?
   Risks include geopolitical tensions, pandemics, regulatory changes, and reliance on single-source suppliers. Diversification and strategic stockpiling are common mitigation strategies.

4. How does regulatory compliance influence suppliers for BETA-VAL?
   Suppliers must meet GMP standards set by agencies like the FDA and EMA. Non-compliance can lead to supply delays, recalls, or market restrictions, emphasizing the importance of regulatory adherence.

5. Are there trends toward local manufacturing of BETA-VAL components?
   Increasingly, companies aim for regional or domestic API production to reduce dependence on imports, especially within the context of national security and supply security initiatives.

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Sources

[1] GlobalData, "Pharmaceutical APIs: Market Analysis," 2022.
[2] US Food and Drug Administration (FDA), "Guidance for Industry – Quality Systems Approach to Pharmaceutical API Manufacturing," 2020.
[3] European Medicines Agency (EMA), "Guidelines on Good Manufacturing Practice," 2021.
[4] ICIS Chemical Business, "API Supply Chain Dynamics," 2022.
[5] Contract Pharma, "Outsourcing Trends in API Manufacturing," 2022.