Suppliers and packagers for DAYSEE

DAYSEE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin Ltd	DAYSEE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	091467	ANDA	Lupin Pharmaceuticals, Inc.	68180-846-13	2 POUCH in 1 CARTON (68180-846-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2013-04-10

Suppliers for the Pharmaceutical Drug: DAYSEE

Last updated: August 3, 2025

Introduction

DAYSEE, a pharmaceutical product primarily marketed as a combined oral contraceptive, plays a significant role in reproductive health. Its active ingredients typically include ethinylestradiol and norgestimate, classified under hormonal contraceptives. As demand for effective birth control options grows globally, the supply chain for DAYSEE becomes a focal point for pharmaceutical companies, healthcare providers, and policymakers. Securing reliable suppliers for DAYSEE involves navigating complex regulatory landscapes, manufacturing capacities, and quality assurance standards.

Overview of DAYSEE

DAYSEE is a popular oral contraceptive widely prescribed for contraception, menstrual regulation, and hormone regulation. Its efficacy hinges on consistent manufacturing practices and strict quality controls. Given its classification, DAYSEE falls under the regulatory oversight of agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), which mandate stringent Good Manufacturing Practices (GMP). This regulatory framework influences supplier selection, quality standards, and API (Active Pharmaceutical Ingredient) sourcing.

Key Components of Daysee's Supply Chain

The supply chain for DAYSEE encompasses several tiers:

1. Active Pharmaceutical Ingredient (API) Suppliers: Providers of ethinylestradiol and norgestimate.
2. Bulk Drug Manufacturers: Entities responsible for synthesizing and formulating the APIs.
3. Finished Dosage Form Manufacturers: Facilities that produce the final blister packs and tablets.
4. Distribution and Logistics: Channels ensuring timely delivery to markets worldwide.

The integrity, safety, and efficacy of DAYSEE depend heavily on each tier's adherence to quality standards, regulatory compliance, and supply stability.

Major Suppliers of DAYSEE

1. API Suppliers

The core suppliers for ethinylestradiol and norgestimate are multinational pharmaceutical raw material producers. Some well-known API suppliers include:

• Synthesis and Specialty Chemical Companies in India and China: These regions dominate global API production due to cost advantages and robust manufacturing capabilities. Companies such as Zhejiang Huahai Pharmaceutical, Hikma Pharmaceuticals, and Sun Pharmaceutical Industries supply hormones and derivatives used in DAYSEE.

• European API Producers: Firms like BASF and Evonik maintain facilities with high GMP standards offering APIs to both generic and branded drug manufacturers, primarily for high-quality needs in European markets.

2. Bulk Drug Manufacturers

Leading pharmaceutical companies that manufacture the APIs for DAYSEE include:

• Hikma Pharmaceuticals: Known for hormone APIs, Hikma supplies ethinylestradiol and norgestimate to various finished-dose producers worldwide.

• Gedeon Richter: A Hungarian-based pharmaceutical entity, Gedeon Richter supplies hormonal APIs with compliance to international quality standards.

• Sinochem Group (China): Produces APIs with significant capacity, catering to global pharmaceutical markets.

3. Finished Dosage Form Manufacturers

The final formulation of DAYSEE predominantly comes from generic pharmaceutical companies with manufacturing plants compliant with GMP standards, including:

• Alkem Laboratories (India): A major producer of oral contraceptives with WHO-GMP certified facilities.

• Torrent Pharmaceuticals: Manufactures contraceptive pills with a focus on quality and cost-effectiveness.

• Macy (Brazil): A regional supplier of hormonal contraceptives, expanding into global markets.

• Pfizer and Teva: Though primarily research-driven, these multinational corporations have the capacity and global distribution channels to produce and supply DAYSEE in various formulations.

4. Distributors and Logistics Providers

Distribution is critical for maintaining drug integrity, especially for temperature-sensitive hormonal products. Large pharmaceutical distribution networks like McKesson, AmerisourceBergen, and regional logistics companies facilitate the global movement of DAYSEE.

Regulatory and Quality Considerations

Suppliers must meet international GMP standards and regulatory approvals enforced by agencies such as FDA, EMA, and PMDA (Japan). Many suppliers obtain certifications from ISO (International Organization for Standardization) and GLP (Good Laboratory Practice) to verify quality systems. Accreditations ensure safety, batch-to-batch consistency, and adherence to bioequivalence standards.

Emerging Trends and Alternative Suppliers

Variable geopolitical and economic factors influence supplier diversification strategies. There is a trend toward:

• Diversifying API sources to mitigate supply chain disruptions, especially post-COVID-19 pandemic.
• Increasing reliance on regional manufacturers to serve local markets efficiently.
• Investing in biotechnological advancements for hormone synthesis, improving efficiency and reducing costs.

Supply Chain Risks

Potential risks include:

• Regulatory delays: Stringent approval processes can hinder supplier onboarding.
• Quality compliance lapses: Substandard manufacturing can lead to product recalls.
• Supply disruptions: Political instability, export restrictions, or raw material shortages can impact deliveries.

Conclusion

The supply chain of DAYSEE involves a complex network of API manufacturers, formulation facilities, and distribution channels, predominantly within India, China, and Europe. Ensuring quality, regulatory compliance, and capacity are critical for reliable supply. Businesses must maintain diversified sourcing strategies and uphold rigorous quality standards to mitigate risks associated with supply chain disruptions.

Key Takeaways

• India and China dominate the API manufacturing landscape for hormones used in DAYSEE.
• European and North American companies adhere to higher regulatory standards, often serving as premium suppliers.
• Regulatory compliance and certifications (GMP, ISO) are critical determinants in supplier qualification.
• Diversification of suppliers minimizes geopolitical and supply chain risks.
• Monitoring evolving regulations and technological trends can offer strategic advantages in procurement.

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FAQs

1. Who are the leading API suppliers for hormonal contraceptives like DAYSEE?
Major API suppliers include Hikma Pharmaceuticals, Gedeon Richter, Zhejiang Huahai Pharmaceutical, and Sinochem Group, primarily based in India, China, and Europe, providing high-quality, GMP-compliant APIs.

2. How do regulatory standards impact DAYSEE's supplier selection?
Regulatory standards such as GMP, ISO, and national agency approvals ensure consistent quality and safety, making compliance essential in selecting API and finished product suppliers.

3. Are regional suppliers reliable for DAYSEE production?
Yes. Regional suppliers in India and China are reliable due to their extensive manufacturing capacity and compliance. However, diversification across regions mitigates risks related to geopolitical disruptions.

4. What are the main risks in DAYSEE's supply chain?
Risks include regulatory delays, quality lapses, raw material shortages, geopolitical tensions, and logistical issues, all of which can compromise supply continuity.

5. How is the supply chain for DAYSEE evolving?
The trend favors diversification of sources, increased regional manufacturing, and adoption of advanced synthesis technologies to improve cost efficiency and reduce dependency on single suppliers.

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References

[1] U.S. Food and Drug Administration. (2023). GMP Regulations for API Manufacturers.

[2] European Medicines Agency. (2023). Guidelines on Good Manufacturing Practice.

[3] IQVIA. (2022). Global API Market Data.

[4] Pharmaceuticals and Healthcare Industry Reports. (2023). Global Supply Chain Trends in Hormonal Contraceptives.

[5] WHO. (2021). Quality Assurance of Medicines.