Suppliers and packagers for brethine

brethine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-721-01	100 TABLET in 1 BOTTLE (62559-721-01)	2018-10-16
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-722-01	100 TABLET in 1 BOTTLE (62559-722-01)	2018-10-16

Suppliers for the Pharmaceutical Drug: Brethine (Terbutaline Sulfate)

Last updated: July 30, 2025

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Introduction

Brethine, the brand name for terbutaline sulfate, is a bronchodilator primarily used to manage asthma, bronchospasm, and preterm labor. As a critical component in respiratory therapy, the supply chain for brethine remains vital for healthcare providers globally. This article provides a comprehensive overview of the key suppliers, manufacturing landscape, and market dynamics influencing brethine's availability, offering insights for pharmaceutical companies, healthcare professionals, and policymakers.

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Overview of Brethine (Terbutaline Sulfate)

Terbutaline sulfate is a selective beta-2 adrenergic receptor agonist that relaxes bronchial smooth muscle, easing airflow. Originally developed in the 1960s, brethine became a widely used emergency and maintenance therapy for respiratory conditions. Its utility extends into obstetric management, where it temporarily halts preterm labor. However, regulatory shifts and safety concerns have impacted its prescribing patterns, influencing supply chain considerations.

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Global Manufacturing Landscape

The manufacturing sector for terbutaline sulfate is concentrated among several key players, primarily within India, China, and Western pharmaceutical hubs. The supply chain encompasses active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors.

Active Pharmaceutical Ingredient (API) Suppliers

India and China dominate API production for terbutaline sulfate, accounting for the majority of global supply. These countries benefit from well-established chemical manufacturing infrastructure, competitive pricing, and extensive export networks.

• Indian Manufacturers

  Indian companies such as Aurobindo Pharma, Hetero Drugs, and Natco Pharma are significant API suppliers. They adhere to stringent manufacturing protocols aligned with Good Manufacturing Practices (GMP) and supply a considerable portion of the international market. Aurobindo, in particular, has consistently expanded its API portfolio, including terbutaline sulfate, serving both generic and branded markets.

• Chinese Manufacturers

  Chinese API producers like Hunan ZYM Chemical Co., Shandong Xinhua Pharmaceutical Co., and others also supply terbutaline sulfate. While often offering competitive prices, some supply chains have faced scrutiny for quality consistency, prompting buyers to conduct rigorous due diligence.

Formulation and Final Product Manufacturing

Formulation takes place across global facilities, often in emerging markets. These manufacturers combine APIs with excipients to produce inhalers, tablets, or subcutaneous formulations. Regulatory adherence and quality assurance play pivotal roles, given the critical nature of respiratory therapeutics.

Market Dynamics and Regulatory Impact

Regulatory actions, primarily by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), have periodically scrutinized brethine, especially due to safety risks associated with off-label use in obstetrics. The decline in prescriptions has led to reduced API demand, prompting some manufacturers to scale down production, thereby impacting global supply.

Additionally, geopolitical considerations, trade policies, and supply chain disruptions—exacerbated by the COVID-19 pandemic—have influenced brethine's availability and sourcing strategies.

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Key Suppliers and Distribution Channels

Supplier	Region	Manufacturing Focus	Certifications	Notes
Aurobindo Pharma	India	API and formulations	GMP, ISO	Major global supplier; extensive export network
Hetero Drugs	India	API production	GMP	Focused on affordability and quality
Natco Pharma	India	API and generics	GMP	Diversified portfolio, including respiratory drugs
Hunan ZYM Chemical Co.	China	API	GMP, ISO	Competitive pricing, variable quality control
Shandong Xinhua Pharmaceutical	China	API and formulations	GMP	Expanding production capacity

Distribution Channels

Distribution of brethine involves a mix of direct sales to hospitals, pharmacies, and government procurement agencies, often through regional distributors. Pharmaceutical wholesalers and importers in North America and Europe play critical roles, especially given the product's declining use for obstetric indications in these regions.

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Market Trends and Challenges

• Declining Prescriptions: Growing safety concerns and regulatory restrictions have led to decreased use of brethine in obstetric indications. This shift has reduced demand, leading to supply adjustments among manufacturers.

• Supply Chain Vulnerabilities: Dependence on Chinese and Indian API producers exposes markets to geopolitical risks, trade tariffs, and quality assurance challenges.

• Regulatory Scrutiny: Increasing post-market surveillance and quality audits limit the pool of approved suppliers, potentially constraining supply.

• Generic Competition: The availability of alternative bronchodilators like salbutamol diminishes brethine’s market share, affecting supplier incentives and production levels.

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Future Outlook

While brethine remains an essential medication for certain indications, its future depends heavily on regulatory approvals and market demand. Suppliers are likely to prioritize quality over volume, with a focus on ensuring compliance with evolving standards. Emerging markets may see increased manufacturing activity due to cost advantages, but regulatory hurdles will persist.

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Key Takeaways

• The primary supply of brethine (terbutaline sulfate) originates from Indian and Chinese API manufacturers, with Indian companies currently leading global exports.

• Regulatory concerns and declining usage in obstetrics have reduced overall demand, prompting some suppliers to scale back production.

• Quality assurance and regulatory compliance are key differentiators among suppliers, influencing procurement decisions.

• Geographic and geopolitical factors introduce vulnerabilities into the supply chain, emphasizing the need for diversified sourcing strategies.

• The future of brethine supply hinges on regulatory landscapes and market demand, with generic manufacturers adapting to evolving safety profiles.

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FAQs

1. Who are the leading global suppliers of terbutaline sulfate (Brethine)?
Indian companies such as Aurobindo Pharma, Hetero Drugs, and Natco Pharma are among the top suppliers, complemented by Chinese manufacturers like Hunan ZYM Chemical Co. These firms provide global markets with API and finished formulations.

2. How has regulatory scrutiny affected brethine's supply chain?
Regulatory agencies’ safety concerns and restrictions have led to reduced prescribing, impacting API demand and prompting some manufacturers to diminish production or exit certain markets, thereby constraining supply.

3. Can alternative suppliers meet global demand for brethine?
Yes, but growing regulatory demands and quality standards require suppliers to maintain rigorous compliance. Diversification beyond traditional suppliers is possible but may be limited by regulatory approvals.

4. What are the risks associated with sourcing brethine API from China and India?
Potential risks include supply disruptions due to geopolitical tensions, trade policy shifts, quality inconsistencies, and capacity limitations—all impacting timely availability.

5. What is the outlook for brethine's future market and supply chain?
While current demand has declined, brethine's role in specific medical contexts ensures ongoing, albeit limited, demand. Supply chains will likely consolidate around trusted suppliers prioritizing quality, with emerging markets increasing their manufacturing footprint.

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References

[1] U.S. Food and Drug Administration (FDA). "Drug Safety Communications." 2020.
[2] Indian Pharmaceutical Alliance. "API Production Capacity Report." 2022.
[3] European Medicines Agency (EMA). "Regulatory Assessment of Bronchodilators." 2021.
[4] MarketWatch. "Global Respiratory Drugs Market Outlook." 2022.
[5] World Health Organization (WHO). "Essential Medicines List." 2021.