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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Ltd	HAILEY 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	204847	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-731-29	3 BLISTER PACK in 1 CARTON (68462-731-29) / 1 KIT in 1 BLISTER PACK	2017-11-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

HAILEY 24 FE is a combined oral contraceptive pill, primarily used for birth control and hormonal regulation. Its formulation typically includes ethinyl estradiol and ferrous fumarate, an iron supplement incorporated to counteract iron deficiency caused by hormonal contraception. As an active pharmaceutical ingredient (API)-based product, its manufacturing involves sourcing high-quality APIs—ethinyl estradiol and ferrous fumarate—and auxiliary excipients, followed by formulation and packaging processes.

Accessing reliable suppliers of these ingredients is critical for pharmaceutical companies aiming to produce HAILEY 24 FE. This article explores leading suppliers, considerations in API procurement, and industry standards to ensure quality, compliance, and supply chain stability.

Key Components of HAILEY 24 FE and Their Suppliers

1. Ethinyl Estradiol Suppliers

Ethinyl estradiol, a synthetic estrogen, is the hormonal component responsible for preventing ovulation. As a high-value API, its supply chain is dominated by several reputable manufacturers.

Bayer AG: One of the earliest and most established producers of ethinyl estradiol, Bayer boasts a comprehensive portfolio of hormonal APIs. Bayer’s stringent quality controls and regulatory compliance make their APIs highly sought after globally.
Mitsubishi Tanabe Pharma Corporation: A leading Japanese pharmaceutical firm, Mitsubishi supplies high-purity ethinyl estradiol with rigorous quality standards.
TEVA Pharmaceuticals: Known for extensive API manufacturing capabilities, TEVA offers ethinyl estradiol for pharmaceutical applications, ensuring cost-effective and reliable supply.
Gland Pharma: An Indian API manufacturer listed on the NASDAQ, Gland Pharma produces estrogenic compounds with global GMP standards, making them a competitive supplier.
Hubei Golden Eyes Pharmaceutical Co., Ltd.: Based in China, this manufacturer supplies bulk ethinyl estradiol with certifications compatible with international pharmaceutical standards.

2. Ferrous Fumarate Suppliers

Ferrous fumarate, an iron supplement, is routinely sourced from multiple manufacturers, especially in regions with established pharmaceutical excipient industries.

Pfizer Inc.: A major global pharmaceutical company that produces ferrous fumarate for both proprietary and third-party manufacturing suppliers.
Moller Pharma Group: Offers ferrous fumarate with high purity, serving as a key supplier to generics and branded pharmaceutical companies.
APL Inc. (India): Known for producing active pharmaceutical ingredients and excipients, APL supplies ferrous fumarate compliant with international standards.
Jiangsu Leili Pharmaceutical Chemical Co., Ltd.: A Chinese manufacturer providing ferrous fumarate with ISO and cGMP certifications.
Pharmaceutique International: A European-based bulk API supplier with certifications for ferrous fumarate, emphasizing high-quality standards.

Qualitative Considerations in API Supplier Selection

Regulatory Compliance & Certifications

All API suppliers must possess certifications relevant to their manufacturing processes, including Good Manufacturing Practice (GMP), Certificate of Suitability (CEP) from the European Medicines Agency (EMA), or Drug Master File (DMF) submissions to the FDA. These ensure APIs meet safety, quality, and efficacy standards critical for pharmaceutical production.

Quality Control & Testing

Top suppliers adhere to rigorous testing protocols, including HPLC purity analysis, residual solvent testing, heavy metal testing, and microbiological assessments. Certificates of analysis (COA) are essential for batch-to-batch verification.

Supply Chain Stability

Reliability stems from diversified sourcing strategies, long-term supplier relationships, and manufacturing capacity. Suppliers with multiple facilities and contingency plans minimize risks of shortages, especially in unpredictable global markets.

Cost & Lead Time

While quality remains paramount, negotiations often consider pricing and lead times. Bulk purchasing agreements and supplier warranties can optimize procurement cost-efficiency.

Industry Trends & Challenges

Global API Market Growth: The API market for hormonal contraceptives is expanding, driven by increasing global demand for affordable contraceptive options. This growth incentivizes continuous supplier expansion and quality improvements (1).
Regulatory Hurdles & Compliance: Stringent approvals by agencies such as the FDA and EMA impose high standards, complicating sourcing processes. Suppliers must maintain compliance to avoid disruptions.
Manufacturing Capacity Constraints: Amid global supply chain disruptions such as those seen during the COVID-19 pandemic, API shortages have occurred. Strategic stockpiling and diversified vendor networks are increasingly vital.
Sustainability & Ethical Sourcing: Increasingly, regulators and companies emphasize sustainable manufacturing practices and ethical sourcing—factors influencing supplier selection.

Key Supplier Regions

India: Leading API manufacturing hub, especially for generics and hormonal compounds due to cost competitiveness and GMP compliance.
China: Expanding API production capacity with competitive pricing; however, quality assurance remains critical.
Europe & North America: Suppliers typically focus on high-quality, regulatory-compliant APIs for markets with stringent standards.

Conclusion

Sourcing high-quality APIs for HAILEY 24 FE involves engaging with reputable, compliant suppliers across multiple regions. Expertise in assessing vendor certifications, quality controls, and supply chain reliability is crucial. Maintaining diversified supplier relationships ensures consistent production, regulatory compliance, and market competitiveness. As the global pharmaceutical landscape evolves, strategic procurement and adherence to industry standards remain pivotal.

Key Takeaways

Prioritize suppliers with GMP certification, comprehensive quality assurance documentation, and proven regulatory compliance.
Diversify API sourcing to mitigate risks of supply chain disruptions.
Monitor industry trends, including regulatory developments and regional manufacturing capacities.
Establish strategic partnerships and long-term agreements with reliable suppliers to ensure competitive pricing and supply stability.
Conduct thorough due diligence on potential suppliers to align with quality, compliance, and sustainability standards.

FAQs

1. How can I verify the quality of APIs from suppliers for HAILEY 24 FE?
Verify certifications such as GMP, CEP, or DMF. Request Certificates of Analysis (COA) for each batch, and consider auditing suppliers’ manufacturing facilities where possible.

2. Are Chinese API manufacturers reliable sources for ethinyl estradiol and ferrous fumarate?
Many Chinese manufacturers meet international standards and hold required certifications. However, due diligence, including audits and validation of quality systems, is essential before engagement.

3. What should be considered when sourcing ferrous fumarate for contraceptive formulations?
Focus on purity levels, compliance certifications, manufacturing capacity, and history of quality control. Confirm supplier adherence to pharmacopeial standards such as USP, EP, or JP.

4. How do regulatory changes impact API supplier selection?
Regulatory updates can tighten compliance requirements, leading to the disqualification of non-compliant suppliers. Staying current with regional regulations ensures sustained approval and market access.

5. What are the risks associated with API shortages in contraceptive production?
Supply interruptions can delay product availability, increase costs, and impact regulatory approvals. Maintaining multiple qualified suppliers and strategic inventories mitigates these risks.

Sources:

MarketWatch. "Global API Market Trends in Hormonal Contraceptives," 2023.

Suppliers and packagers for HAILEY 24 FE

HAILEY 24 FE

Suppliers for the Pharmaceutical Drug: HAILEY 24 FE