BLISOVI FE 1.5/30: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin Ltd	BLISOVI FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	201585	ANDA	Lupin Pharmaceuticals, Inc.	68180-866-73	3 POUCH in 1 CARTON (68180-866-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2019-11-07
Lupin Ltd	BLISOVI FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	201585	ANDA	Lupin Pharmaceuticals, Inc.	68180-869-13	3 POUCH in 1 CARTON (68180-869-13) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2025-08-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 26, 2025

Introduction

BLISOVI FE 1.5/30 is a combined oral contraceptive pill that contains ethinylestradiol (1.5 mg) and levonorgestrel (30 mcg). It is used primarily for pregnancy prevention and sometimes for regulating menstrual cycles. Given the highly regulated nature of contraceptive drugs, understanding the global supply chain and key suppliers for BLISOVI FE 1.5/30 provides valuable insights into manufacturing geography, market competition, and potential sourcing strategies.

This article provides a detailed analysis of current and potential suppliers for BLISOVI FE 1.5/30, evaluating the pharmaceutical manufacturing landscape, the major players involved in active pharmaceutical ingredient (API) production, formulation, and packaging, and the regulatory considerations influencing the supply chain.

Manufacturing and Supply Chain Overview

The manufacturing of oral contraceptives like BLISOVI FE 1.5/30 involves two core stages: API synthesis and finished dosage formulation. These stages often occur in different geographic locations, dictated by regulatory standards, quality control capabilities, and cost efficiencies.

Active Pharmaceutical Ingredient (API) Suppliers

The API comprises ethinylestradiol and levonorgestrel. Both are synthetic hormones, with established manufacturing processes largely dominated by a handful of global API manufacturers due to the complexity and regulatory barriers of hormonal synthesis.

Ethinylestradiol API Suppliers

Ethinylestradiol is a widely produced API with many manufacturers spanning Asia, Europe, and North America. Notable API suppliers include:

Hepeng Pharmaceutical (China): One of China’s leading hormone API manufacturers, Hepeng manufactures a broad spectrum of steroidal APIs, including ethinylestradiol, leveraging low-cost production capabilities and established export channels [1].
Hainan Haiwang Pharmaceutical (China): Focused on hormonal APIs, this company supplies ethinylestradiol globally, adhering to regulatory standards, including cGMP.
Hovione (Portugal): A European API producer with high-quality standards, Hovione supplies pharmaceutical companies across the globe, including hormonal APIs such as ethinylestradiol.
KPC (Korea Pharmaceutical and Bio-Pharma Co., South Korea): Known for producing hormone APIs with stringent manufacturing practices.

Levonorgestrel API Suppliers

Levonorgestrel’s synthesis is more complex but remains concentrated among specialized API manufacturers:

Ichimaru Pharcos (Japan): A pioneer in hormonal APIs, Ichimaru Pharcos supplies levonorgestrel for global contraceptive markets with high-quality standards.
Hepeng Pharmaceutical (China): Also active in producing levonorgestrel, providing cost-effective options for generics.
Lupin Ltd. (India): A major Indian pharmaceutical company with proven capacity for hormone API manufacturing, including levonorgestrel, with cGMP compliance [2].

Finished Dosage Manufacturing

The formulation of BLISOVI FE 1.5/30 combines the API into a tablet using excipients and manufacturing processes adhering to regulatory standards.

Leading pharmaceutical contract manufacturing organizations (CMOs) and pharmaceutical companies produce finished tablets:

Gedeon Richter (Hungary): A notable pharmaceutical firm with extensive contraceptive product lines, including manufacturing capabilities for oral combination pills.
Famar (Greece): A European CMO specializing in oral solid dosage manufacturing, including hormonal contraceptives.
Siegfried (Switzerland): Provides formulation, packaging, and manufacturing services for oral contraceptives across Europe.
Local manufacturers in India and China: Many regional pharmaceutical companies produce generic versions of contraceptives, including BLISOVI FE 1.5/30, often sourcing APIs from the above suppliers.

Key Suppliers and Geographical Distribution

Asia-Pacific Region

China: The dominant API supplier region for ethinylestradiol and levonorgestrel due to cost competitiveness and manufacturing capacity. Hepeng Pharmaceutical and others dominate hormone API manufacturing here.
India: Increasingly significant in hormone API production, with companies like Lupin and Orchid Pharma meeting global demand.
South Korea: Home to high-quality API manufacturers such as KPC, offering compliance with international standards.

Europe

Portugal: Hovione provides high-quality APIs and has a strong reputation in the contraceptive API supply chain.
Hungary and Greece: Host well-established formulation manufacturing facilities, including Gedeon Richter and Famar.

North America & Other Regions

North American companies are more involved in finished dosage manufacturing, with a focus on high compliance standards.

Regulatory and Quality Considerations

The supply chain for BLISOVI FE 1.5/30 must meet stringent regulatory standards, including cGMP compliance, quality control, and adherence to bioequivalence benchmarks. Many Asian API suppliers have made significant investments in cGMP certifications to access European and North American markets but face challenges related to regulatory harmonization.

Additionally, the ongoing patent landscape and market exclusivity rights influence supplier selection, particularly for branded versus generic formulations. Prominent companies like Lupin, Mylan, and Teva often source APIs from certified suppliers to ensure regulatory approval for their contraceptive products.

Emerging Trends and Market Dynamics

Shift towards vertical integration: Some pharmaceutical companies aim to control both API manufacturing and formulation to mitigate supply chain risks and reduce costs. This trend affects the competitive landscape and supplier selection.
Global supply chain disruptions: The COVID-19 pandemic highlighted vulnerabilities in the hormonal API supply chain, prompting diversification strategies and increased emphasis on regional manufacturing.
Regulatory harmonization efforts: Initiatives like ICH guidelines facilitate cross-border API manufacturing and quality assurance, impacting supplier eligibility.

Conclusion

The supply chain for BLISOVI FE 1.5/30 spans multiple regions, with primary API manufacturing concentrated in China, India, and Portugal. The dominant suppliers include Hepeng Pharmaceutical for APIs and European firms like Hovione and Famar for formulation. Market players’ ability to ensure quality and regulatory compliance remains paramount.

Pharmaceutical companies seeking supply stability should consider diversified sourcing from reputable, certified suppliers and stay attentive to regulatory developments influencing API approval and market access. As the contraceptive market matures, investments in supply chain resilience will define competitive positions.

Key Takeaways

API sourcing is centralized among regional leaders: Chinese manufacturers dominate ethinylestradiol supply, while India and Japan are key levonorgestrel producers.
Quality and regulatory compliance are critical: Suppliers must meet international standards like cGMP to ensure market access in regulated regions.
Diversification mitigates supply risks: Companies should diversify sourcing strategies across regions and suppliers to prevent disruptions.
Contract manufacturing is prevalent: Many pharmaceutical companies rely on CMOs for formulation, emphasizing the importance of strategic partnerships.
Emerging trends impact procurement: Vertical integration and increased regional manufacturing capacity are shaping the future supply landscape.

FAQs

Q1: Who are the primary API suppliers for BLISOVI FE 1.5/30?

A: The main API suppliers include Hepeng Pharmaceutical (China) for both ethinylestradiol and levonorgestrel, as well as Lupin Ltd. (India) and Ichimaru Pharcos (Japan), which supply high-quality APIs suitable for regulated markets.

Q2: What regions dominate the manufacturing of BLISOVI FE 1.5/30?

A: Asia-Pacific, primarily China and India, dominate API production, while Europe, particularly Portugal and Hungary, excels in formulation and finished dosage manufacturing.

Q3: How do regulatory standards affect the supply chain for hormonal contraceptives?

A: Regulatory standards like cGMP certification dictate supplier eligibility, ensuring product quality and safety, thus influencing sourcing decisions and supply continuity.

Q4: Are there upcoming supplier shifts for BLISOVI FE 1.5/30?

A: The industry trend indicates diversification, with a focus on regional manufacturers and increased capacity in India and Southeast Asia due to cost advantages and supply resilience needs.

Q5: How can companies mitigate supply chain risks for hormonal APIs?

A: Strategies include diversifying API sources, enforcing strict supplier qualification processes, maintaining inventory buffers, and fostering long-term partnerships with reputable manufacturers.

References

[1] Hepeng Pharmaceutical Annual Report, 2022.
[2] Lupin Ltd. Corporate Overview, 2023.

Suppliers and packagers for BLISOVI FE 1.5/30

BLISOVI FE 1.5/30

Suppliers for the Pharmaceutical Drug: BLISOVI FE 1.5/30