GILDESS FE 1.5/30 pharmaceutical API fine chemical sources

Subscribe to access the full database, or Get Started Free
Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical	⤷ Get Started Free	2023-05-5H05635	⤷ Get Started Free
>Vendor	>Vendor Homepage	>Vendor Sku	>API Url

Last updated: September 5, 2025

Introduction

GILDESS FE 1.5/30**, a combined oral contraceptive, contains 1.5 mg of norethindrone acetate (a progestin) and 30 micrograms of ethinyl estradiol (a synthetic estrogen). As an essential pharmaceutical product used for contraception, its production hinges on a reliable supply chain of high-quality active pharmaceutical ingredients (APIs). This review delineates key global sources of APIs for GILDESS FE 1.5/30, analyzing the current market landscape, quality standards, and supply dynamics to inform pharmaceutical manufacturers and stakeholders.

Overview of API Requirements

To formulate GILDESS FE 1.5/30, pharma companies require:

Norethindrone Acetate (NAT): A synthetic progestin with antiestrogenic activity.
Ethinyl Estradiol (EE): A potent estrogen used in oral contraceptives.

Quality, purity, and compliance with international standards (e.g., WHO GMP, USFDA, EMA) are crucial in sourcing these APIs.

Global API Manufacturing Landscape

1. Norethindrone Acetate API Sources

Historically, primary sources of NAT originate from Asia, particularly China and India, which dominate the production due to cost efficiency, manufacturing capacity, and robust export infrastructures.

China: Major producer of generic NAT APIs, with companies like Zhejiang Xianju Pharmaceutical Co., Ltd. and Shandong Xinhua Pharmaceutical Co., Ltd., offering APIs compliant with international standards. The Chinese market benefits from extensive manufacturing capacity and competitive pricing, although regulatory scrutiny is increasing.
India: Companies such as Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries, and Lupin Ltd. manufacture NAT an API with focus on quality and compliance. Indian APIs are widely exported worldwide, with many complying with strict quality standards.
Europe and North America: Limited local production of NAT APIs; mainly rely on imports from Asian suppliers or contract manufacturing organizations (CMOs). European companies like GVK Biosciences have capabilities for API synthesis, but overall volume remains limited compared to Asian sources.

2. Ethinyl Estradiol API Sources

EE API manufacturing is concentrated in China, India, and some European regions, with China and India accounting for the bulk of global supply.

China: Leading producers include Zhejiang Jiangxi Pharmaceutical Co., Ltd. and Anhui Anqing Pharmaceutical Co., Ltd., providing high-quality EE APIs meeting global regulatory standards. Their capacity supports large-scale demand for contraceptives globally.
India: Manufacturers such as Hetero Labs and Cipla produce EE API with high purity, serving both domestic and export markets. India's EE API export volume continues to grow, driven by competitive pricing and regulatory compliance.
Europe: European firms like Merck and Bayer have differentiated production capabilities, but their API markets are limited and more focused on high-purity products for specialty formulations.

Quality Standards and Regulatory Considerations

API sourcing for GILDESS FE 1.5/30 demands adherence to stringent quality standards:

Good Manufacturing Practice (GMP): Mandatory for all suppliers handling APIs intended for human use.
Pharmacopoeial Compliance: APIs should meet USP, EP, or JP monographs, or equivalent standards.
Regulatory Approvals: Suppliers must demonstrate successful validation and compliance with global regulatory agencies (FDA, EMA, PMDA).

Manufacturers increasingly prefer suppliers with proven track records, stable quality, and transparent supply chain documentation.

Market Trends and Supply Dynamics

Supply Chain Diversification

Consolidation among Chinese and Indian API manufacturers has led to increased supply security. However, recent geopolitical tensions and trade policies exert pressure on supply stability. Pharmaceutical companies are exploring diversified sourcing, including regional API production and strategic stockpiling.

Cost and Quality Balance

While Asian APIs offer cost advantages, quality assurance remains paramount. Regulatory audits and validation processes are rigorous, emphasizing the need for robust quality management systems among suppliers.

Innovation and Contract Manufacturing

Emerging technologies may lead to alternative synthesis routes and improved purity profiles, influencing API source choices. Contract manufacturing organizations (CMOs) are increasingly playing a vital role in API sourcing, offering flexibility, scalability, and compliance.

Major API Suppliers for GILDESS FE 1.5/30

API	Leading Suppliers	Country	Market Position
Norethindrone Acetate	Zhejiang Xianju Pharmaceutical, Sun Pharmaceutical, Dr. Reddy’s	China, India	Major Asian producers, high-quality, compliant
Ethinyl Estradiol	Zhejiang Jiangxi Pharmaceutical, Hetero Labs, Cipla	China, India	Large-scale production, globally trusted suppliers

Conclusion

Reliable sources of APIs for GILDESS FE 1.5/30 primarily stem from Chinese and Indian manufacturers, characterized by extensive capacity, cost advantages, and adherence to quality standards. As regulatory landscapes tighten, ensuring supplier compliance with GMP and pharmacopoeial standards is critical for consistent product quality. The market remains dynamic, with ongoing innovations and geopolitical factors influencing supply chain stability.

Key Takeaways

Asian manufacturers dominate the supply of APIs for GILDESS FE 1.5/30, with China and India leading in capacity and quality.
Quality assurance and regulatory compliance are non-negotiable; sourcing from GMP-certified suppliers minimizes risks.
Supply chain diversification reduces dependency on single-source countries, aiding resilience amid geopolitical disruptions.
Contract manufacturing organizations provide scalable, compliant API supply options, especially for complex synthesis pathways.
Market trends point towards increased scrutiny of API origin and quality, prompting manufacturers to strengthen supplier audits and validation processes.

FAQs

1. What are the primary geographic regions supplying APIs for GILDESS FE 1.5/30?
Primarily China and India, with European suppliers playing a minor but significant role in high-quality API provision.

2. How do regulatory standards impact API sourcing decisions?
Suppliers must demonstrate compliance with GMP, meet pharmacopoeial standards, and obtain necessary certifications to ensure regulatory approval of finished products.

3. Are there regional differences in API quality and cost?
Yes. Asian APIs generally offer cost advantages, but European APIs may provide higher perceived quality due to stringent regulations; sourcing depends on balancing cost, quality, and regulatory requirements.

4. How does geopolitical tension influence API supply for GILDESS FE 1.5/30?
Trade restrictions and tariffs can disrupt supply chains, emphasizing the need for diversified sourcing strategies and strategic inventory management.

5. What future trends could affect API sourcing for oral contraceptives?
Emerging regulations, unification of quality standards, and technological innovations in API synthesis could refine sourcing options, increase competition, and drive quality improvements.

Sources
[1] Global Pharmaceutical API Market Analysis, 2022
[2] WHO GMP Certification Database, 2023
[3] Industry Reports on Chinese and Indian API Manufacturers, 2022
[4] Regulatory Guidelines for API Quality Assurance, FDA, EMA
[5] Market Intelligence on API Supply Chain Dynamics, 2023

Bulk Pharmaceutical API Sources for GILDESS FE 1.5/30