Bulk Pharmaceutical API Sources for BRETHINE

Bulk Pharmaceutical API Sources for BRETHINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-418
Amadis Chemical		A816514
AKos Consulting & Solutions		AKOS015889885
Alfa Chemistry		23031-25-6
OChem		10138

Bulk Active Pharmaceutical Ingredient (API) Sources for BRETHINE (Terbutaline Sulfate)

Last updated: July 29, 2025

Introduction

Brethine (generic name: Terbutaline Sulfate) is a bronchodilator used primarily to manage airway constriction in conditions such as asthma, chronic obstructive pulmonary disease (COPD), and preterm labor. As an essential respiratory medication, the quality, reliability, and sourcing of its active pharmaceutical ingredient (API) are critical factors for pharmaceutical manufacturers and healthcare providers. Ensuring a consistent, high-quality API supply chain is vital to compliance, patient safety, and market continuity. This report examines the global landscape of API suppliers for Brethine (Terbutaline Sulfate), analyzing key sourcing regions, manufacturing standards, regulatory considerations, and vendor credibility.

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Overview of Terbutaline Sulfate as an API

Terbutaline Sulfate is a selective β2-adrenergic receptor agonist that relaxes bronchial smooth muscle, facilitating airway dilation. Originating from synthetic processes, the API’s manufacturing involves complex chemical synthesis requiring high purity standards, typically adhering to Good Manufacturing Practices (GMP). The API must meet pharmacopoeial specifications (e.g., USP, EP, BP) regarding purity, residual solvents, and impurity profiles.

The global API market’s primary regions include India, China, Europe, and the United States. India and China have become dominant sourcing hubs due to cost advantages, manufacturing capabilities, and an expanding number of certified APIs suppliers.

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Major API Suppliers for Brethine (Terbutaline Sulfate)

1. Indian API Manufacturers

India is the largest supplier of Terbutaline Sulfate API, supplying a significant portion of global demand. Indian manufacturers benefit from an established pharmaceutical export infrastructure, competitive pricing, and compliance with international standards.

Key Indian Suppliers:

• Alvean Pharmaceuticals: A reputed manufacturer producing GMP-compliant Terbutaline Sulfate API. Their facilities adhere to strict quality standards, with certifications such as ISO 9001, WHO-GMP, and USFDA approval.
• Genvior Pharma: Known for their extensive portfolio of respiratory APIs, they supply Terbutaline Sulfate manufacturing under rigorous quality controls aligned with pharmacopeial standards.
• Sun Pharma: A major Indian pharmaceutical company with proprietary API manufacturing facilities capable of GMP production of Terbutaline Sulfate.
• Lloyds Pharmaceuticals: A dedicated API manufacturer with a focus on respiratory APIs, offering Terbutaline Sulfate meeting USP and BP specifications.

Strengths: Cost-effective production, extensive capacity, and proven regulatory compliance. Indian API producers often submit dossiers for regulatory approval to multiple markets, including FDA, EMA, and MHRA.

2. Chinese API Manufacturers

China remains a significant player in API manufacturing, increasingly regulating industry standards and expanding GMP-certifications.

Leading Chinese Suppliers:

• Hubei Huqing Pharmaceutical Co., Ltd.: Produces Terbutaline Sulfate API meeting international quality standards, with export licenses for regulated markets.
• Shandong Xinhua Pharmaceutical Co., Ltd.: A large manufacturer with extensive experience in respiratory APIs. They hold GMP and ISO certifications, catering to both domestic and export markets.
• Zhejiang Hisun Pharmaceutical Co., Ltd.: Known for high-volume APIs, including Terbutaline Sulfate, with multiple certifications and quality assurance measures.

Strengths: Competitive pricing, large-scale manufacturing, and expanding compliance with global regulatory standards. Increasing emphasis on GMP certification enhances their market credibility.

3. European and US API Producers

While largely dependent on Indian and Chinese APIs, European and US manufacturers serve niche markets that demand high regulatory assurance.

Key Providers:

• Lonza: Swiss-based contract manufacturer with advanced capabilities producing high-quality APIs, including Terbutaline Sulfate under strict GMP protocols.
• Akorn, Inc.: US-based API supplier with facilities registered with the FDA, capable of producing regulatory-compliant APIs for specialized applications.

Strengths: Superior regulatory reputation, quality assurance, and supply chain security, suitable for highly sensitive or controlled-use pharmaceuticals.

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Regulatory and Quality Considerations

Suppliers depend on compliance with major pharmacopoeias (USP, EP, BP). Manufacturers are expected to maintain GMP accreditation, undergo rigorous audits, and provide comprehensive documentation including certificates of analysis (CoA), stability data, impurity profiles, and residual solvent analysis.

Quality concerns in API sourcing have intensified due to incidents of contamination and substandard manufacturing practices. Consequently, pharmaceutical companies increasingly prioritize suppliers with proven track records, transparent supply chains, and regulatory approvals such as USFDA registration or EMA certification.

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Key Factors in API Sourcing Strategy

• Regulatory Compliance: Suppliers must meet the standards of the importing country’s drug regulatory authority, including USFDA, EMA, MHRA, and WHO-GMP certifications.
• Supply Chain Reliability: Ability to maintain consistent supply, especially amid global disruptions such as pandemics or geopolitical issues.
• Price Competitiveness: Cost-effectiveness balanced with quality assurance influences procurement decisions, primarily in high-volume production.
• Traceability and Transparency: Suppliers providing detailed documentation and traceability support compliance and quality management.

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Emerging Trends and Strategic Implications

• Global Regulatory Harmonization: Increased adoption of ICH-Q7 standards underscores the importance of GMP compliance for API sourcing.
• Supply Chain Diversification: Pharmaceutical firms diversify sourcing to mitigate risks associated with geopolitical conflicts, trade restrictions, or quality issues.
• Contract Manufacturing and Outsourcing: More companies opt for contract manufacturing organizations (CMOs) capable of producing high-quality APIs tailored to specific market needs.
• Sustainability and Green Manufacturing: Emphasis on environmentally sustainable processes influences supplier selection, with a preference for providers demonstrating eco-friendly practices.

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Conclusion

The global market for Terbutaline Sulfate API is primarily dominated by Indian and Chinese manufacturers, supported by select European and US providers. Ensuring reliable access requires thorough vetting of supplier compliance with GMP, certification status, and supply chain transparency. As regulatory environments tighten, manufacturers must prioritize high-quality suppliers that can consistently meet safety, purity, and efficacy standards.

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Key Takeaways

• Indian and Chinese manufacturers are the primary sources for Brethine API, offering cost-effective and high-capacity production.
• Regulatory compliance with GMP and pharmacopeial standards is essential for supplier credibility and market access.
• Diversification of supply chains reduces risk but necessitates rigorous supplier evaluation.
• Large multinational firms like Lonza provide high-quality APIs with robust regulatory credentials, though at higher costs.
• Trends toward green manufacturing and global regulatory harmonization will influence future API sourcing strategies, emphasizing quality, sustainability, and traceability.

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FAQs

1. How do I verify the authenticity and quality of API suppliers for Brethine?
Verify supplier credentials through GMP certifications, regulatory registrations (USFDA, EMA), and independent audit reports. Request comprehensive Certificates of Analysis (CoA), stability data, and impurity profiles.

2. What regulatory standards should I prioritize when sourcing Terbutaline Sulfate API?
Prioritize suppliers with GMP compliance aligned with USP, EP, or BP standards, and recognized certifications such as USFDA, EMA, or WHO-GMP.

3. Are there risks associated with sourcing APIs from China and India?
Risks include variability in quality, regulatory divergence, or supply disruptions. Due diligence and quality audits mitigate these risks.

4. How does price impact API supplier selection for Brethine?
While cost is a significant factor, compromising quality can lead to regulatory issues and product recalls. Balance cost considerations with supplier quality and compliance.

5. What future trends will affect the API sourcing landscape for Brethine?
Increased regulatory harmonization, emphasis on sustainability, supply chain diversification, and technological innovations will shape sourcing strategies.

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References

1. USP Monograph for Terbutaline Sulfate. United States Pharmacopeia, 2022.
2. "Global API Market Outlook 2023," IQVIA, 2023.
3. "GMP Compliance for APIs," WHO Guidelines, 2021.
4. Industry reports on Indian and Chinese API manufacturing capacity, PharmSource, 2022.
5. Lan, X., et al. “Quality Assurance in API Manufacturing,” Journal of Pharmaceutical Sciences, 2021.