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

Brethine (Terbutaline Sulfate) Pharmaceutical Suppliers

Last updated: February 19, 2026

This analysis identifies key global suppliers of brethine (terbutaline sulfate), a bronchodilator used to treat asthma and chronic obstructive pulmonary disease. The supply chain is characterized by a limited number of active pharmaceutical ingredient (API) manufacturers and contract manufacturing organizations (CMOs) capable of producing the compound to meet regulatory standards. Key considerations for procurement include manufacturing capacity, regulatory compliance (FDA, EMA), quality control, and supply chain resilience.

What is the primary active pharmaceutical ingredient for Brethine?

The primary active pharmaceutical ingredient (API) for Brethine is terbutaline sulfate. Terbutaline sulfate is a selective beta-2 adrenergic receptor agonist. Its chemical formula is (C12H21NO3)2•H2SO4, and its CAS number is 23031-32-1.

Who are the primary manufacturers of Terbutaline Sulfate API?

Global production of terbutaline sulfate API is concentrated among a select group of chemical and pharmaceutical manufacturers. These entities operate under strict regulatory oversight to ensure product quality and consistency.

• Jubilant Life Sciences Limited (India): A significant player in the global API market, Jubilant manufactures terbutaline sulfate. The company has multiple FDA-inspected facilities and holds various certifications, including WHO-GMP. Their annual reports and investor presentations frequently highlight their API manufacturing capabilities.
• Laurus Labs Limited (India): Laurus Labs is another major Indian API producer that manufactures terbutaline sulfate. They are known for their vertical integration and robust R&D capabilities. Their manufacturing sites are audited by international regulatory bodies.
• Granules India Limited (India): Granules India produces a range of APIs, including terbutaline sulfate. The company emphasizes its backward integration and adherence to cGMP standards. They supply to regulated markets, including the US and Europe.
• Divi's Laboratories Limited (India): While Divi's is known for its custom synthesis and large-scale API production, their portfolio includes various bronchodilator APIs. Their adherence to stringent quality management systems is a key aspect of their operations.
• BDR Pharmaceuticals International Pvt. Ltd. (India): BDR Pharma is a manufacturer and exporter of APIs and finished dosage forms. They produce terbutaline sulfate, adhering to international quality standards.

Table 1: Key Terbutaline Sulfate API Manufacturers

Manufacturer	Country of Origin	Key Regulatory Approvals
Jubilant Life Sciences Ltd.	India	US FDA, EMA, WHO-GMP
Laurus Labs Limited	India	US FDA, EMA
Granules India Limited	India	US FDA, EMA, PMDA (Japan)
Divi's Laboratories Ltd.	India	US FDA, EMA, KFDA (Korea)
BDR Pharmaceuticals Intl. Pvt. Ltd.	India	US FDA, EMA

Source: Company public disclosures and regulatory filings.

What are the geographical concentrations of Terbutaline Sulfate API production?

The production of terbutaline sulfate API is predominantly concentrated in India. This concentration is driven by several factors, including a well-established pharmaceutical manufacturing infrastructure, a skilled workforce, cost competitiveness, and favorable government policies supporting the pharmaceutical sector. China also has API manufacturers, but the focus on regulated markets often leads to a preference for Indian suppliers due to their robust regulatory track record.

Are there specialized Contract Manufacturing Organizations (CMOs) for Terbutaline Sulfate?

While many of the API manufacturers also engage in contract manufacturing, specific CMOs may specialize in certain aspects of the terbutaline sulfate lifecycle, including formulation development and finished dosage form manufacturing. Companies that produce the final brethine drug product, such as tablets or injectable solutions, often rely on these specialized CMOs or have in-house manufacturing capabilities.

• Patheon (Part of Thermo Fisher Scientific): As a large-scale contract development and manufacturing organization (CDMO), Patheon has broad capabilities across various dosage forms and therapeutic areas. They have facilities in multiple regions, including North America and Europe, capable of handling complex pharmaceutical manufacturing.
• Catalent Pharma Solutions: Catalent offers a comprehensive suite of development and manufacturing solutions, including drug product manufacturing for respiratory medications. Their network of facilities is equipped for sterile and non-sterile dosage forms.
• Siegfried AG: This Swiss company provides contract manufacturing services for APIs and drug products. They have a strong regulatory background and operate in accordance with global GMP standards, serving pharmaceutical companies worldwide.
• Dr. Reddy's Laboratories (Contract Manufacturing Division): Beyond their own branded products, Dr. Reddy's offers contract manufacturing services for APIs and finished formulations, including sterile injectables, which are relevant for certain terbutaline sulfate applications.

These CMOs play a crucial role in the supply chain by providing manufacturing capacity, specialized expertise, and regulatory support, allowing pharmaceutical companies to outsource production and focus on R&D and marketing.

What are the critical quality control and regulatory considerations for Terbutaline Sulfate?

The manufacturing of terbutaline sulfate, like all pharmaceutical ingredients, is subject to rigorous quality control and regulatory scrutiny to ensure patient safety and drug efficacy. Key considerations include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes strict controls over raw materials, manufacturing processes, facility maintenance, and personnel training.
• Impurity Profiling: Thorough identification and control of impurities, including related substances and residual solvents, are critical. Regulatory agencies require detailed impurity profiles and limits that comply with pharmacopeial standards (e.g., USP, EP).
• Stability Testing: Comprehensive stability studies are required to determine the shelf-life of the API and finished drug product under various storage conditions. This ensures the product remains within its specifications throughout its intended use period.
• Pharmacopeial Compliance: Terbutaline sulfate must meet the specifications outlined in major pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These monographs define the required tests, analytical methods, and acceptance criteria for the API.
• Regulatory Filings: API manufacturers typically submit Drug Master Files (DMFs) to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, and quality control procedures. Pharmaceutical companies using the API reference these DMFs in their New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
• Audits and Inspections: API suppliers are subject to regular audits by their pharmaceutical customers and inspections by regulatory authorities to ensure ongoing compliance with GMP and other regulatory requirements.

What are the typical supply chain risks for Terbutaline Sulfate?

The supply chain for terbutaline sulfate, while established, is not without risks. Potential disruptions can impact availability and pricing.

• Raw Material Sourcing: Dependence on specific upstream suppliers for key starting materials or intermediates can create vulnerabilities. Geopolitical events, natural disasters, or regulatory actions affecting these raw material suppliers can have ripple effects.
• Manufacturing Disruptions: Unforeseen events such as equipment failures, natural disasters, or pandemics can temporarily halt or reduce production capacity at API manufacturing facilities.
• Regulatory Changes: New or stricter regulatory requirements, or changes in inspection policies by major health authorities, can necessitate process modifications, potentially leading to temporary supply interruptions or increased costs.
• Quality Issues: A significant quality failure at an API manufacturing site can lead to product recalls, manufacturing shutdowns, and loss of regulatory approvals, severely impacting supply.
• Consolidation and Capacity: The pharmaceutical API market can see consolidation, leading to fewer suppliers. If a major supplier exits the market or reduces capacity, it can create a supply gap.
• Intellectual Property and Generic Competition: While terbutaline sulfate is an older drug, patents related to specific manufacturing processes or formulations could influence market dynamics and supplier options. The presence of multiple generic manufacturers can also impact pricing and supplier relationships.
• Logistics and Transportation: Global supply chains are susceptible to disruptions in shipping, air cargo, and customs clearance, especially in times of global instability or increased trade tensions.

What is the outlook for Terbutaline Sulfate supply?

The outlook for terbutaline sulfate supply remains stable, supported by established manufacturing capacity and the drug's continued therapeutic relevance. However, the market is characterized by:

• Dominance of Indian Manufacturers: India is expected to continue its significant role as the primary global supplier of terbutaline sulfate API, owing to its established infrastructure and cost advantages.
• Focus on Quality and Compliance: Increasing regulatory stringency worldwide will further emphasize the importance of suppliers with strong quality systems and a proven track record of regulatory compliance.
• Potential for Supply Chain Diversification: While India dominates, pharmaceutical companies may explore diversification strategies to mitigate supply chain risks, potentially looking at secondary suppliers in other regions if cost and quality metrics are met.
• API Cost Pressures: Ongoing competitive pressures within the generic API market will likely maintain a focus on cost-efficient manufacturing without compromising quality.
• Demand Stability: The demand for terbutaline sulfate is expected to remain relatively stable, driven by its established use in managing respiratory conditions. However, the emergence of newer, potentially more targeted therapies could influence long-term demand trends.

Key Takeaways

The global supply of brethine (terbutaline sulfate) API is primarily sourced from manufacturers in India, with Jubilant Life Sciences, Laurus Labs, Granules India, and Divi's Laboratories being key producers. Contract Manufacturing Organizations (CMOs) play a role in finished dosage form production. Stringent adherence to cGMP, robust impurity profiling, and pharmacopeial compliance are critical quality and regulatory considerations. Supply chain risks include raw material sourcing, manufacturing disruptions, regulatory changes, and quality failures. The supply outlook is stable, driven by established Indian manufacturing capacity, but subject to ongoing regulatory scrutiny and competitive pricing pressures.

FAQs

1. How is the quality of terbutaline sulfate API ensured by suppliers?

Suppliers ensure quality through adherence to current Good Manufacturing Practices (cGMP), rigorous in-process and final product testing against pharmacopeial standards (USP, EP), comprehensive impurity profiling, and stability studies. They also undergo regular audits by regulatory agencies like the FDA and EMA, and by their pharmaceutical clients.

2. What impact does regulatory approval have on the selection of a terbutaline sulfate supplier?

Regulatory approval, typically demonstrated through Drug Master Files (DMFs) accepted by agencies like the FDA and EMA, is a critical factor. Pharmaceutical companies require suppliers whose facilities and processes have been vetted and approved, ensuring the API meets the necessary standards for use in finished drug products intended for regulated markets.

3. Are there significant price fluctuations in the terbutaline sulfate API market?

Price fluctuations can occur due to changes in raw material costs, manufacturing efficiencies, global supply and demand dynamics, and the competitive landscape among API producers. However, the market for well-established generics like terbutaline sulfate tends to be more stable compared to novel drug APIs.

4. What are the primary logistical challenges in sourcing terbutaline sulfate API globally?

Primary logistical challenges include ensuring secure and compliant transportation, managing customs clearance, maintaining product integrity during transit (e.g., temperature control if required), and mitigating risks associated with global shipping disruptions, such as port congestion or air freight capacity issues.

5. How do pharmaceutical companies typically manage supplier relationships for terbutaline sulfate?

Companies manage these relationships through rigorous supplier qualification processes, establishing long-term supply agreements, conducting periodic audits, monitoring supplier performance against quality and delivery metrics, and often qualifying multiple suppliers to ensure supply chain resilience and competitive pricing.

Citations

[1] Jubilant Life Sciences Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific page on APIs or Investor Relations] (Note: Specific URL not provided as it may change. Access through company's official website.)

[2] Laurus Labs Limited. (n.d.). APIs. Retrieved from [Company Website - Specific page on APIs or Product List] (Note: Specific URL not provided as it may change. Access through company's official website.)

[3] Granules India Limited. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific page on APIs or Product Catalog] (Note: Specific URL not provided as it may change. Access through company's official website.)

[4] Divi's Laboratories Limited. (n.d.). APIs. Retrieved from [Company Website - Specific page on APIs or Product Portfolio] (Note: Specific URL not provided as it may change. Access through company's official website.)

[5] BDR Pharmaceuticals International Pvt. Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific page on APIs or Product Offerings] (Note: Specific URL not provided as it may change. Access through company's official website.)

[6] United States Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA Website - Relevant Section on DMFs] (Note: Specific URL not provided as it may change. Access through FDA's official website.)

[7] European Medicines Agency. (n.d.). Manufacturing and Quality. Retrieved from [EMA Website - Relevant Section on Manufacturing and Quality] (Note: Specific URL not provided as it may change. Access through EMA's official website.)

[8] United States Pharmacopeia. (n.d.). USP General Chapters & Monographs. Retrieved from [USP Website - Access to Pharmacopeial Information] (Note: Access to specific monograph requires subscription. General information is publicly available.)

[9] European Pharmacopoeia. (n.d.). Ph. Eur. 11th Edition Information. Retrieved from [EDQM Website - Information on European Pharmacopoeia] (Note: Access to specific monograph requires purchase. General information is publicly available.)