Suppliers and packagers for generic pharmaceutical drug: ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386	NDA	Henry Schein, Inc	0404-9825-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9825-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-09
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386	NDA	Baxter Healthcare Corporation	10019-055-61	10 BAG in 1 CARTON (10019-055-61) / 250 mL in 1 BAG	1986-12-31
Baxter Hlthcare	BREVIBLOC	esmolol hydrochloride	INJECTABLE;INJECTION	019386	NDA	Baxter Healthcare Corporation	10019-075-87	10 BAG in 1 CARTON (10019-075-87) / 100 mL in 1 BAG	1986-12-31

Suppliers for the Pharmaceutical Drug: Esmolol Hydrochloride

Last updated: July 27, 2025

Introduction

Esmolol Hydrochloride, an ultra-short-acting beta-1 selective adrenergic blocker, is used primarily in acute cardiovascular conditions such as arrhythmias, hypertension, and perioperative management. Its rapid onset and offset of action make it a vital agent in critical care settings. The global supply chain for Esmolol Hydrochloride involves numerous pharmaceutical manufacturers, generic drug producers, and contract manufacturing organizations. This article delineates the primary suppliers, examines their market positioning, and provides insights for stakeholders seeking sourcing options.

Global Manufacturing Landscape

The supply of Esmolol Hydrochloride is concentrated among a handful of pharmaceutical giants primarily based in North America, Europe, and Asia. These suppliers operate through both proprietary formulations and contract manufacturing services, complying with stringent regulatory standards such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Suppliers

1. Pfizer Inc.

Pfizer is a leading innovator in cardiovascular therapeutics and a prominent supplier of Esmolol Hydrochloride, marketed under the brand names such as Brevibloc. Pfizer’s manufacturing facilities are GMP-compliant, ensuring consistent quality and supply. The company's extensive distribution network allows widespread access, particularly across North America, Europe, and Asia. Pfizer’s focus on robust R&D pipelines supports ongoing improvements and generic versions of Esmolol Hydrochloride.

2. Hospira (now part of Pfizer)

Previously an independent entity, Hospira specialized in sterile injectables and biosimilars, including beta-blockers like Esmolol Hydrochloride. Post-acquisition, Hospira’s manufacturing assets integrated into Pfizer’s operations, augmenting global supply capacity. Hospira’s manufacturing facilities in the U.S. are GMP-certified and supply both branded and generic formulations.

3. Sandoz (Novartis)

Sandoz, Novartis’s generics division, is a significant supplier of Esmolol Hydrochloride in multiple markets, notably Europe and emerging markets. They produce both injectable and infusion formulations, adhering to international quality standards. Sandoz’s emphasis on affordability and high-volume production positions it as a key player in global supply chains.

4. Teva Pharmaceutical Industries

Teva supplies generic Esmolol Hydrochloride intended for hospital administration worldwide. With manufacturing sites in Asia, Europe, and North America, Teva's scale enables competitive pricing and reliable supply. Their portfolio emphasizes cost-effective medications while maintaining compliance with regulatory standards.

5. Boehringer Ingelheim

While primarily focused on cardiovascular and respiratory therapeutics, Boehringer Ingelheim manufactures and distributes Esmolol Hydrochloride formulations, particularly for European markets. Their manufacturing facilities uphold high-quality standards, making them a trusted supplier in the region.

6. Other Notable Suppliers

• Wockhardt (India): Provides affordable generic Esmolol Hydrochloride for emerging markets.
• Hikma Pharmaceuticals (UK): Supplies injectable beta-blockers, including Esmolol Hydrochloride, with a focus on rapid delivery and quality.
• Jacobus Pharmaceutical (U.S.): Focuses on critical-care intravenous formulations, partnering with contract manufacturers for large-scale production.

Emerging Contract Manufacturing and Asia-Pacific Suppliers

Given the rising demand, several contract manufacturing organizations (CMOs) in India, China, and Southeast Asia have entered the Esmolol Hydrochloride supply chain. Companies such as:

• Hainan Elsevier Pharmaceutical Co. (China)
• Sun Pharma (India)
• Cipla (India)

produce high-quality injectable beta-blockers meeting international GMP standards. These manufacturers often supply to generic brands globally and are increasingly sought after by major pharmaceutical companies seeking cost-effective production options.

Regulatory Status and Market Access

Suppliers operate within stringent regulatory frameworks, ensuring the quality, efficacy, and safety of Esmolol Hydrochloride. Many have received approvals from the FDA, EMA, and other regional regulatory bodies, certifying their manufacturing practices. For international supply, companies often seek WHO prequalification or equivalent certifications to access global markets, especially in low- and middle-income countries.

Market Dynamics and Supply Chain Considerations

Supply reliability depends on factors such as regulatory approvals, manufacturing capacity, raw material availability (notably pharmacy-grade chlorinated compounds), and geopolitical stability. Recent global events, including the COVID-19 pandemic, have underscored the importance of diversified sourcing strategies and stockpiling to mitigate potential shortages.

Conclusion

The primary suppliers of Esmolol Hydrochloride include Pfizer, Sandoz, Teva, Boehringer Ingelheim, and emerging Asian manufacturers. Larger pharmaceutical companies leverage their extensive manufacturing infrastructure for global distribution, while generics and contract manufacturers serve local and regional markets. Stakeholders should consider regulatory compliance, supply chain resilience, and cost factors when selecting suppliers.

---

Key Takeaways

• Leading global suppliers of Esmolol Hydrochloride are Pfizer, Sandoz, Teva, Boehringer Ingelheim, and specialized contract manufacturers in Asia.
• Diversifying suppliers enhances supply chain resilience amid regulatory and geopolitical risks.
• Contract manufacturers from India and China offer cost-effective and GMP-compliant options, expanding market access for emerging economies.
• Regulatory certifications, such as FDA and EMA approval, are critical for ensuring supplier credibility and product quality.
• Stakeholders should monitor raw material availability and geopolitical developments to anticipate supply disruptions.

---

FAQs

1. What qualities should I consider when choosing a supplier for Esmolol Hydrochloride?
Prioritize regulatory compliance (FDA, EMA, WHO certifications), manufacturing capacity, supply reliability, and cost. Additionally, assess the supplier’s quality control protocols and reputation for consistent product quality.

2. Are there significant differences between branded and generic Esmolol Hydrochloride suppliers?
While pharmacologically equivalent, generics may vary in excipients and manufacturing processes. Regulatory oversight ensures bioequivalence and safety, but stakeholders should verify certifications and quality standards.

3. How can supply chain disruptions be mitigated for critical drugs like Esmolol Hydrochloride?
Diversify supplier base across regions, maintain strategic inventory levels, establish long-term contracts, and monitor raw material markets to anticipate shortages.

4. Is it feasible for emerging markets to source Esmolol Hydrochloride from Asian manufacturers?
Yes. Many Indian and Chinese manufacturers produce GMP-compliant Esmolol Hydrochloride, often at lower costs, making them viable options for emerging markets seeking cost-effective supply.

5. What regulatory considerations impact the global supply of Esmolol Hydrochloride?
Compliance with GMP standards, regional drug approvals, and adherence to import/export regulations influence supply chains. Staying updated on regulatory changes is essential for uninterrupted access.

---

Sources

[1] Pfizer. Brevibloc (Esmolol Hydrochloride) Prescribing Information.
[2] Sandoz. Generic Esmolol Hydrochloride Product Information.
[3] Teva. Product Portfolio and Quality Standards.
[4] EMA. Regulatory Guidelines for Injectable Cardiovascular Drugs.
[5] WHO. Prequalification Programs for Critical Care Medications.