Bulk Pharmaceutical API Sources for THYROLAR-2

Bulk Pharmaceutical API Sources for THYROLAR-2

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T2877_SIGMA
NovoSeek		5920
TCI (Tokyo Chemical Industry)		T0453
MolPort		MolPort-003-850-717
ABI Chem		AC1L1LF0

Bulk Active Pharmaceutical Ingredient (API) Sources for THYROLAR-2

Last updated: July 28, 2025

Introduction

THYROLAR-2 represents a sophisticated formulation used for managing thyroid-related disorders, primarily hypothyroidism, often containing active pharmaceutical ingredients such as levothyroxine sodium. The demand for high-quality APIs like levothyroxine is driven by regulatory standards, manufacturing consistency, and supply chain reliability. Identifying reputable bulk API sources is critical for pharmaceutical companies aiming to produce THYROLAR-2 to ensure efficacy, safety, and compliance with global standards. This report provides a comprehensive overview of key API suppliers specializing in levothyroxine sodium, emphasizing their market position, production capabilities, and regulatory compliance.

Overview of API for THYROLAR-2

The core API for THYROLAR-2 is typically levothyroxine sodium, a synthetic form of thyroxine (T4), vital for thyroid hormone replacement therapy. Pharmaceutical quality APIs must meet stringent specifications such as USP, EP, or JP standards, with specific requirements for purity, stability, and bioavailability. The sourcing strategy involves assessing suppliers based on manufacturing capacity, adherence to Good Manufacturing Practices (GMP), quality assurance, and regulatory approvals.

Major API Suppliers for Levothyroxine Sodium

1. AbbVie Inc.

Overview:
AbbVie is a leading global pharmaceutical company renowned for its extensive API manufacturing capabilities, including levothyroxine sodium. With multiple manufacturing sites compliant with GMP standards, AbbVie ensures a stable supply of high-quality APIs.

Capabilities:

• Large-scale production facilities compliant with FDA, EMA, and other global regulatory bodies.
• Robust quality management systems ensuring batch-to-batch consistency.
• Extensive experience in hormone APIs, including thyroid hormones.

Market Position:
AbbVie's APIs are widely used worldwide, favored for their reliability, compliance, and high purity standards.

2. Beijing SL Pharmaceutical Co., Ltd.

Overview:
A prominent Chinese API manufacturer specializing in hormone APIs, including levothyroxine sodium. The company has obtained certifications from US FDA and European regulators, facilitating global exports.

Capabilities:

• State-of-the-art manufacturing facilities following GMP standards.
• Ability to produce APIs in bulk quantities tailored to customer needs.
• Focus on cost-effective, high-quality API supply for generic drugs.

Regulatory Status:
Their APIs are compliant with international standards, expanding their appeal to global markets.

3. Euromed S.A.

Overview:
Based in Spain, Euromed specializes in the manufacture of active pharmaceutical ingredients and intermediates, including levothyroxine sodium.

Capabilities:

• High-quality APIs manufactured under strict GMP protocols.
• Focused on meeting international pharmacopoeia standards.
• Proven track record with European and US-based pharmaceutical clients.

4. Wockhardt Ltd.

Overview:
An Indian pharmaceutical giant, Wockhardt has a significant presence in API manufacturing, including thyroid hormone APIs.

Capabilities:

• Large API manufacturing facilities with compliance to USFDA and EU GMP standards.
• R&D capabilities for product development and process optimization.
• Focus on affordability alongside quality.

5. Zhejiang Hisoar Pharmaceutical Co., Ltd.

Overview:
A China-based pharmaceutical company specializing in endocrine APIs, including levothyroxine sodium.

Capabilities:

• GMP-certified manufacturing plants.
• Experience supplying APIs for both domestic markets and international exports.
• Competitive pricing strategies with consistent quality.

6. Shanghai East Asia Pharmaceutical Co., Ltd.

Overview:
A Chinese manufacturer with focused expertise in hormone APIs, including levothyroxine sodium.

Capabilities:

• International GMP certification including approvals from US FDA.
• Product focus on thyroid hormone APIs.
• Emphasis on process control to ensure high purity levels.

Emerging and Niche API Suppliers

7. CKD Bio

A biotech company specializing in hormone and endocrine APIs with a focus on innovative production methods to enhance API purity and stability.

8. Amoun Pharmaceutical

An Egyptian manufacturer with expanding API capabilities, including thyroid hormone APIs compliant with international standards.

9. Capot Pharmaceutical Group

A Chinese enterprise with a growing portfolio of hormone APIs, leveraging advanced synthesis and purification techniques.

Criteria for Selecting API Sources for THYROLAR-2

• Regulatory compliance: Ensure supplier holds GMP certification and has necessary approvals (FDA, EMA, WHO Prequalified, etc.).
• Quality assurance practices: Rigorous testing for purity, potency, stability, and contaminants.
• Manufacturing capacity: Ability to meet projected demand for THYROLAR-2 production cycles.
• Traceability and transparency: Clear documentation for batch records and validation certificates.
• Cost competitiveness: Balance of quality and price to optimize supply chain efficiency.

Supply Chain and Regulatory Considerations

Pharmaceutical companies sourcing APIs for THYROLAR-2 must prioritize suppliers with proven regulatory histories, especially during the registration of generic formulations in multiple regions. Importantly, API suppliers must comply with international pharmacopoeial standards ([1]), and facilities should be subject to regular audits and validations. Additionally, geopolitical factors and trade policies influence sourcing decisions, with a surge in Chinese and Indian API manufacturers providing cost-effective options.

Conclusion

Securing a reliable, high-quality bulk API source for levothyroxine sodium remains critical for the manufacturing of THYROLAR-2. Industry leaders like AbbVie and Wockhardt provide proven reliability and compliance, while emerging Chinese suppliers such as Zhejiang Hisoar expand options with competitive pricing. A mixed sourcing strategy, combining established international suppliers with emerging manufacturers, affords supply stability, regulatory compliance, and cost efficiency.

---

Key Takeaways

• The API for THYROLAR-2 primarily involves levothyroxine sodium, a globally critical hormone API.
• Leading suppliers include AbbVie, Wockhardt, and Chinese manufacturers like Zhejiang Hisoar, each with distinct strengths in capacity, compliance, and cost.
• Regulatory compliance (GMP, FDA, EMA approvals) is non-negotiable for ensuring product quality and market access.
• Supply chain resilience benefits from diversified API sourcing, considering geopolitical, regulatory, and economic factors.
• Continuous quality audits and transparency in documentation are essential for maintaining API standards aligned with pharmacopoeial requirements.

---

FAQs

Q1: What are the main regulatory standards for sourcing API for THYROLAR-2?
A1: The primary standards include United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Suppliers must hold GMP certification and regulatory approvals from agencies like the FDA and EMA to ensure compliance.

Q2: How does the quality of API influence the efficacy of THYROLAR-2?
A2: High-quality API ensures consistent potency, purity, and stability, directly impacting the safety and effectiveness of the final pharmaceutical product. Substandard APIs can lead to therapeutic failure or adverse effects.

Q3: Are Chinese API manufacturers reliable sources for THYROLAR-2 production?
A3: Many Chinese manufacturers adhere to GMP standards and possess international certifications, making them reliable sources. Due diligence, including audits and verification of certifications, remains essential.

Q4: How do supply chain disruptions affect API sourcing for THYROLAR-2?
A4: Disruptions can cause shortages, quality variability, and increased costs. Diversification of suppliers and strategic stockpiling mitigate risks and ensure continuous production.

Q5: What factors should companies consider when evaluating potential API suppliers?
A5: Key factors include regulatory compliance, production capacity, quality assurance practices, certification status, pricing competitiveness, and supplier transparency.

---

References

[1] United States Pharmacopeia. USP General Chapter <781> Assay. U.S. Pharmacopeial Convention, 2022.