Bulk Pharmaceutical API Sources for aminoglutethimide

Bulk Pharmaceutical API Sources for aminoglutethimide

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jhiP`@DA@KHheHhibmfR]yjjXHB`@@
Sigma-Aldrich		A9657_SIGMA
NovoSeek		2145
MP Biomedicals		153645
Vitas-M Laboratory		STK802074
TCI (Tokyo Chemical Industry)		A1947

Bulk Active Pharmaceutical Ingredient (API) Sources for Aminoglutethimide

Last updated: July 30, 2025

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Introduction

Aminoglutethimide is a synthetic antineoplastic and corticosteroid synthesis inhibitor predominantly used in the treatment of hormone-dependent cancers such as breast cancer and select endocrine disorders. As a critical component in pharmaceutical manufacturing, sourcing high-quality bulk APIs—Active Pharmaceutical Ingredients—is essential for ensuring drug efficacy, regulatory compliance, and supply chain stability. This article explores the current landscape of aminoglutethimide API sourcing, highlighting primary suppliers, manufacturing regions, quality considerations, and industry trends.

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Overview of Aminoglutethimide API

Aminoglutethimide functions by inhibiting the aromatization process of androgens into estrogens, thereby reducing estrogen levels in hormone-sensitive conditions. Given its potent biological activity, the API must meet stringent quality standards. The sourcing process involves assessing supplier reliability, manufacturing practices, and regulatory compliance, all of which impact the therapeutic safety and performance of final pharmaceutical products.

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Global Market and Regional Production

1. Manufacturing Regions and Key Players

The primary regions engaged in aminoglutethimide API production include:

• India: A long-standing hub for generic APIs owing to cost advantages and robust manufacturing infrastructure. Several Indian pharmaceutical companies produce aminoglutethimide API, such as Sun Pharmaceutical Industries Ltd., Aurobindo Pharma, and Cipla. Indian firms often supply both domestic and international markets, with some partnering through licensing agreements with Western companies.

• China: The country's growing API sector provides competitively priced APIs with increasing regulatory oversight. Chinese manufacturers like Zhejiang NHU Co., Ltd. and Shanghai Saiking Chemical Co., Ltd. have expanded their portfolio to include aminoglutethimide, emphasizing quality management and GMP compliance.

• Europe and North America: Less prevalent as primary producers, European and North American firms tend to focus on formulation, API R&D, or higher value-added specialty chemicals. Nonetheless, some European companies such as Evonik Industries and BASF produce quality APIs for certified markets, often as part of broader pharmaceutical excipient or active ingredient portfolios.

2. Contract Manufacturing Organizations (CMOs)

Outsourcing manufacturing to CMOs is common, especially for companies requiring scalable production, quality assurance, and regulatory adherence. Leading CMOs with capabilities in aminoglutethimide synthesis include:

• Dishman Pharmaceuticals and Chemicals Limited (India)
• AMRI (USA/India)
• Boehringer Ingelheim (Germany)

These organizations often facilitate global supply chains, ensuring consistent quality and delivery.

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Sourcing Considerations for Aminoglutethimide API

1. Quality and Regulatory Compliance

Ensuring API quality involves verification of Good Manufacturing Practice (GMP) certification, batch consistency, and analytical validation. Regulatory bodies such as the US FDA, EMA, and other local agencies mandate strict quality standards, including residual solvent limits, impurity profiles, and potency assays.

Suppliers providing Certificates of Analysis (CoA), stability data, and compliance documentation are preferred. For international markets, sourcing from approved vendor lists mitigates regulatory risks.

2. Supply Chain Reliability

API manufacturers with diversified production facilities and supply chain transparency offer better risk mitigation against disruptions. Stability of supply is critical, particularly for oncology drugs like aminoglutethimide, where treatment continuity impacts patient outcomes.

3. Cost Dynamics

Pricing factors are influenced by manufacturing complexity, raw material availability, and regional economic conditions. Indian and Chinese manufacturers tend to offer competitive pricing, but scrutiny of quality standards remains paramount.

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Emerging Trends and Industry Dynamics

1. Regulatory Stringency and Quality Assurance

The global shift toward stringent quality standards, especially post-GDPR and ICH Q7 guidelines, elevates compliance expectations. Suppliers investing in modern facilities, comprehensive analytical capabilities, and quality management systems are gaining favor.

2. Increasing Demand for Generic APIs

Market dynamics indicate rising demand for generic aminoglutethimide APIs driven by increasing cancer prevalence and cost-conscious healthcare systems. This trend incentivizes existing manufacturers to expand capacity and new entrants to target niche markets.

3. Supply Chain Resilience and Localization

Global disruptions, such as the COVID-19 pandemic, underscore the importance of localized manufacturing, inventory buffers, and diversified supply networks. Companies are reevaluating sourcing strategies to reduce dependence on single regions.

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Key Suppliers and Notable API Producers

Region	Major Companies	Notable Attributes
India	Sun Pharma, Aurobindo, Cipla	Cost-competitive, GMP compliant
China	Zhejiang NHU, Shanghai Saiking	Growing capacity, regulatory improvements
Europe/North America	Evonik, BASF, Teva	Focus on high quality and regulatory adherence
Global CMOs	Dishman, AMRI, WuXi AppTec	Contract manufacturing, scalable supply

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Quality Standards and Regulatory Pathways

Manufacturers must adhere to:

• GMP requirements for pharmaceutical APIs
• Established analytical validation procedures
• Proper documentation and traceability
• Compliance with ICH Q7 guidelines for active ingredients

Certified APIs enable streamlined registration and approval processes in target markets.

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Concluding Remarks

The supply landscape for aminoglutethimide API is characterized by a mix of established Asian manufacturers, emerging Chinese suppliers, and select Western producers focusing on high regulatory compliance. Cost efficiency, supply chain resilience, and quality assurance are central to sourcing decisions. As demand for hormone-related therapies continues to grow, securing reliable, high-quality APIs remains a strategic priority for pharmaceutical firms globally.

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Key Takeaways

• Regional Diversification: India and China dominate aminoglutethimide API manufacturing, offering cost advantages but requiring stringent quality assessments.
• Regulatory Compliance: Working with GMP-certified suppliers and validating analytical methods are essential for market approval.
• Supply Chain Stability: Diversifying suppliers and engaging with vetted CMOs mitigate risks associated with geopolitical and logistical disruptions.
• Industry Trends: Growing generic demand and regulatory tightening underscore the importance of qualified suppliers and scalable manufacturing.
• Partnering Strategies: Collaborating with established manufacturers and CMOs enhances credibility and ensures a steady supply of high-quality API.

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FAQs

Q1: What are the primary considerations when sourcing aminoglutethimide API?
Ensuring GMP compliance, verifying product purity and potency, supplier reliability, and regulatory acceptance are paramount.

Q2: Which regions are the main producers of aminoglutethimide API?
India and China are the leading manufacturing regions, with European and North American firms primarily involved in high-compliance manufacturing or formulation.

Q3: How do quality standards influence API sourcing decisions?
Strict adherence to GMP, comprehensive analytical validation, and reliable documentation ensure regulatory approval and therapeutic safety.

Q4: What industry trends impact aminoglutethimide API sourcing?
Increasing demand for generics, regulatory tightening, and supply chain resilience initiatives drive the shift toward diversified and localized manufacturing.

Q5: Are contract manufacturing organizations a viable option for aminoglutethimide API supply?
Yes, well-established CMOs offer scalable, compliant manufacturing solutions, often with cost and supply chain benefits.

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Sources

[1] OECD, Active Pharmaceutical Ingredients (APIs): Manufacturing, Quality and Regulation, 2022.
[2] Indian Pharmaceutical Alliance, Indian API Industry Report 2022, 2022.
[3] China Pharmaceutical Industry Association, API Market Trends and Regulatory Updates, 2021.
[4] US FDA, Guidance for Industry: Quality Agreements, 2018.
[5] ICH Q7, Guideline for Good Manufacturing Practice for Active Pharmaceutical Ingredients, 2001.