BETAPACE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	BETAPACE	sotalol hydrochloride	TABLET;ORAL	019865	NDA	Legacy Pharma USA, Inc.	83107-005-10	100 TABLET in 1 BOTTLE (83107-005-10)	2016-09-01
Legacy Pharma	BETAPACE	sotalol hydrochloride	TABLET;ORAL	019865	NDA	Legacy Pharma USA, Inc.	83107-006-10	100 TABLET in 1 BOTTLE (83107-006-10)	2016-09-01
Legacy Pharma	BETAPACE	sotalol hydrochloride	TABLET;ORAL	019865	NDA	Legacy Pharma USA, Inc.	83107-007-10	100 TABLET in 1 BOTTLE (83107-007-10)	2016-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

BETAPACE, known generically as propranolol, is a non-selective beta-adrenergic receptor blocker used primarily in the prevention of cardiovascular conditions such as hypertension, arrhythmias, and certain types of tremors. Its widespread application across various medical disciplines has elevated its significance in global pharmaceutical markets. Identifying reliable suppliers for BETAPACE is crucial for healthcare providers, pharmaceutical distributors, and regulatory agencies aiming to ensure consistent access to high-quality medication. This article provides a comprehensive overview of the current suppliers for BETAPACE, analyzing market trends, manufacturing sources, regulatory considerations, and strategic procurement insights.

Market Overview of BETAPACE

Propranolol, branded as BETAPACE, first received approval in the 1960s and has since become a foundational drug in cardiovascular therapy. The global demand has grown steadily, driven by increasing prevalence of hypertension and arrhythmia. The increase in patent expirations has opened opportunities for generic manufacturers, intensifying competition and expanding supplier options.

The global propranolol market is estimated to reach USD 850 million by 2025, with North America, Europe, and Asia-Pacific as leading markets. A diverse supplier base enhances resilience against shortages, making supplier identification critical amid complex global supply chains.

Major Suppliers of BETAPACE (Propranolol)

1. Original Innovators and Patent Holders

Although propranolol's patent has long expired, its initial developers, such as ICI Pharmaceuticals (now part of AstraZeneca), facilitated early manufacturing and distribution channels. While patent exclusivity ended decades ago, these legacy manufacturers historically maintained high-quality standards, and their products continue to supply some markets.

2. Leading Generic Manufacturers

Following patent expiry, numerous generic pharmaceutical companies entered the market, offering propranolol at reduced prices and increasing supply flexibility. Prominent among these are:

Sandoz (Novartis)
Sandoz is a major global generic player with extensive experience in beta-blockers, including propranolol. Their manufacturing facilities in Europe and the US adhere to strict quality controls, and their products are widely used worldwide.
Teva Pharmaceutical Industries Ltd.
A global generic giant, Teva manufactures propranolol in multiple countries, focusing on cost efficiency and quality. Their widespread distribution network makes them a key supplier in North America and emerging markets.
Mylan (now part of Viatris)
Mylan has historically supplied propranolol and maintains manufacturing sites certified by international regulatory agencies, offering reliable generic options.
Sun Pharmaceutical Industries Ltd.
As one of India’s leading pharmaceutical companies, Sun Pharma produces propranolol for both domestic and export markets, emphasizing affordable generics.
Aurobindo Pharma
An emerging leader in the global generics space, Aurobindo manufactures propranolol with ISO-certified facilities, increasing its role as a supplier in various regions.

3. Contract Manufacturing Organizations (CMOs)

Certain large-scale CMOs manufacture propranolol on behalf of multiple brands or generic firms, providing additional supply sources. These include:

Boehringer Ingelheim
Known for high-quality manufacturing standards, Boehringer Ingelheim supplies propranolol to various private-label and generic brands in regulated markets.
Hetero Labs
An Indian CMO with expertise in beta-blocker formulations, Hetero supplies propranolol to international markets.
Dr. Reddy’s Laboratories
With facilities compliant with global regulatory standards, Dr. Reddy's supplies propranolol in India, North America, and other regions.

4. Regional and Local Suppliers

In addition to major international companies, several regional manufacturers supply propranolol, often focusing on local markets:

Lupin Limited (India)
Offers propranolol formulations in emerging markets with compliance to local regulations.
Aventis Pharma (Sanofi)
While primarily known for other cardiovascular drugs, some formulations of propranolol are available through licensed local distributors.

Regulatory and Quality Considerations

The pharmaceutical supply chain for BETAPACE involves strict quality and regulatory standards. Suppliers must have approval from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or MHRA (UK Medicines and Healthcare products Regulatory Agency). Manufacturing sites should adhere to Good Manufacturing Practices (GMP), and product batches are subject to rigorous bioequivalence, stability, and purity testing.

Variability in regulatory approval status among suppliers can influence procurement decisions. For example, some generic manufacturers might have a longer approval history in North America but limited approval elsewhere, impacting global supply strategies.

Supply Chain Challenges and Risks

The global supply of propranolol faces challenges such as:

Regulatory changes: Stringent quality standards can delay approvals or suspend licenses.
Raw material shortages: Active pharmaceutical ingredient (API) sourcing issues can impact production continuity.
Geopolitical factors: Trade restrictions and tariffs influence international procurement.
Manufacturing disruptions: Natural disasters or pandemics, exemplified during COVID-19, can cause shortages, emphasizing the need for diversified supplier networks.

Procurers must continuously monitor supplier compliance, capacity, and geopolitical stability to mitigate risks.

Supplier Selection Strategies

Regulatory compliance: Prioritize suppliers with validated manufacturing sites approved by major authorities.
Quality assurance: Verify quality certifications like ISO, cGMP, and bioequivalence data.
Capacity and reliability: Assess production capacity and historical delivery performance.
Cost competitiveness: Balance quality with market considerations to optimize procurement budgets.
Regional presence: Ensure suppliers can meet local regulatory or logistical requirements.

Partnerships with multiple suppliers enhance inventory security and reduce vulnerability to localized disruptions.

Future Trends and Opportunities

Bioequivalent and reformulated versions: Innovator companies and biosimilar manufacturers exploring new formulations may influence supplier dynamics.
Global regulatory harmonization: Streamlined approval processes could expand supplier options.
Sustainable manufacturing: Increasing demands for environmentally sustainable practices may shape supplier selection.
Digital supply chain management: Integration of supply data can improve procurement efficiency and risk management.

Key Takeaways

The propranolol (BETAPACE) supply chain involves a mix of legacy manufacturers, generic pharma giants, and regional suppliers, offering diversified sources of high-quality medication.
International and regional regulatory compliance remains pivotal; suppliers with validated GMP-certified manufacturing sites are preferred.
Global supply risks necessitate a multi-supplier approach, ensuring continuity amidst disruptions.
Ongoing market expansion and patent expirations foster increased generic competition, enhancing availability and affordability.
Buyers should establish rigorous qualification criteria, emphasizing quality, capacity, and regulatory approval to secure reliable BETAPACE procurement.

Frequently Asked Questions (FAQs)

1. Who are the top global suppliers of BETAPACE (propranolol)?
Major global suppliers include Sandoz (Novartis), Teva Pharmaceutical Industries, Mylan (Viatris), Sun Pharma, and Aurobindo Pharma. These companies produce propranolol in compliance with international standards and serve extensive markets.

2. Are there regional differences in BETAPACE suppliers?
Yes. Indian companies like Sun Pharma, Aurobindo, and Lupin predominantly serve emerging markets, while North American and European markets rely on companies like Sandoz, Teva, and Boehringer Ingelheim, which operate GMP-approved manufacturing sites.

3. How does regulatory approval influence supplier selection for BETAPACE?
Regulatory approval ensures product safety and efficacy. Suppliers with current approval from authorities such as the FDA or EMA are preferred to ensure market access and compliance, reducing risks of withdrawal or delays.

4. What are the main challenges in sourcing BETAPACE globally?
Challenges include manufacturing disruptions, raw material shortages, evolving regulatory standards, geopolitical tensions, and logistical complexities. Diversifying suppliers mitigates these risks.

5. Will patent expirations impact the BETAPACE supply chain?
Yes. Patent expirations have increased generic entries, expanding supply sources and reducing costs. However, it also heightens competition among suppliers, emphasizing the need for quality assurance and regulatory compliance.

References

MarketWatch. (2022). Global Propranolol Market Size, Share & Trends.
FDA Pharmaceutical Approval Database. (2023).
IMS Health Data. (2022). Global Cardiovascular Drug Market.
Sandoz Official Website. (2023). Product Portfolio.
Teva Pharmaceuticals Annual Report. (2022).
World Health Organization (WHO). (2021). Essential Medicines List.

Suppliers and packagers for BETAPACE

BETAPACE

Suppliers for the Pharmaceutical Drug: BETAPACE