Suppliers and packagers for LO LOESTRIN FE

LO LOESTRIN FE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	Allergan, Inc.	0430-0420-14	5 BLISTER PACK in 1 CARTON (0430-0420-14) / 1 KIT in 1 BLISTER PACK	2010-12-01
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	Allergan, Inc.	0430-0420-60	8 CARTON in 1 TRAY (0430-0420-60) / 30 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	2010-12-01
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	Allergan, Inc.	0430-0420-95	6 CARTON in 1 TRAY (0430-0420-95) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	2010-12-01
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501	NDA	A-S Medication Solutions	50090-1456-0	1 KIT in 1 KIT (50090-1456-0)	2010-12-01

LO LOESTRIN FE Supplier Landscape

Last updated: February 19, 2026

Lo Loestrin Fe, a low-dose oral contraceptive containing norethindrone acetate and ethinyl estradiol, presents a complex supply chain involving multiple active pharmaceutical ingredient (API) suppliers and contract manufacturers. The market for such contraceptives is mature, with established players and significant global production capacity. Analysis of the supplier landscape is critical for assessing supply chain resilience, cost optimization, and potential for market entry or diversification for stakeholders.

What Are the Primary Active Pharmaceutical Ingredients (APIs) in Lo Loestrin Fe?

Lo Loestrin Fe contains two primary APIs:

• Norethindrone Acetate (NA): A progestin hormone.
• Ethinyl Estradiol (EE): An estrogen hormone.

The iron component of Lo Loestrin Fe is ferrous fumarate, a common dietary supplement, which is typically sourced from a distinct set of suppliers.

Who Are the Key Suppliers of Norethindrone Acetate (NA)?

Norethindrone Acetate is a well-established API with multiple global manufacturers. Key suppliers include:

• Hubei Biocause Pharmaceutical Co., Ltd.: A significant producer of steroid hormones.
• Shandong Xinhua Pharmaceutical Co., Ltd.: A major Chinese pharmaceutical manufacturer with steroid API capabilities.
• Cheman Pharmaceuticals Private Limited: An Indian API manufacturer specializing in steroid hormones.
• Taj Pharmaceuticals Ltd.: Another Indian company with a presence in steroid API production.
• Amneal Pharmaceuticals: While primarily known as a generic drug manufacturer, Amneal also has API manufacturing capabilities.
• Gedeon Richter Plc.: A European pharmaceutical company with substantial experience in steroid synthesis.

The production of NA involves complex multi-step synthesis, often starting from diosgenin or other steroidal precursors. The quality and consistency of these starting materials directly impact the final API. Production sites are concentrated in regions with established chemical and pharmaceutical manufacturing infrastructure, notably China and India.

Who Are the Key Suppliers of Ethinyl Estradiol (EE)?

Ethinyl Estradiol is another critical API for Lo Loestrin Fe. Similar to NA, its production is concentrated among specialized API manufacturers. Key suppliers include:

• Hubei Biocause Pharmaceutical Co., Ltd.: Also a producer of ethinyl estradiol.
• Shandong Xinhua Pharmaceutical Co., Ltd.: Manufactures EE alongside other steroid APIs.
• Cheman Pharmaceuticals Private Limited: Supplies EE as part of its steroid hormone portfolio.
• Taj Pharmaceuticals Ltd.: Offers EE as a key product in its API offerings.
• Gedeon Richter Plc.: A consistent supplier of EE.
• Centrient Pharmaceuticals (formerly DSM Nutritional Products): Has historically been a significant player in the steroid hormone API market.

The synthesis of EE also requires specialized chemical processes. Regulatory scrutiny on EE production is high due to its potent pharmacological activity. Companies demonstrating robust quality control systems and adherence to Good Manufacturing Practices (GMP) are preferred suppliers.

Who Are the Key Suppliers of Ferrous Fumarate?

Ferrous fumarate is a widely available commodity chemical used as an iron supplement. Its suppliers are more diverse and less specialized compared to the hormone APIs. Key suppliers include:

• Foodchem International Corporation: A supplier of food and pharmaceutical ingredients.
• Xi'an Natural Field Bio-Technique Co., Ltd.: Offers various pharmaceutical intermediates and ingredients.
• Ranbaxy Laboratories Ltd. (now part of Sun Pharmaceutical Industries): While primarily a finished dosage form manufacturer, they also have API capabilities, including iron salts.
• Various chemical manufacturers in India and China: Numerous smaller and medium-sized enterprises produce ferrous fumarate for global markets.

The sourcing of ferrous fumarate is generally less constrained by complex synthesis or stringent regulatory hurdles compared to the hormonal APIs. Price and bulk availability are primary selection criteria.

What Contract Manufacturers Are Involved in Lo Loestrin Fe Production?

The final formulation and packaging of Lo Loestrin Fe are typically handled by contract manufacturing organizations (CMOs) or by the brand owner's internal manufacturing facilities. The specific CMOs can change based on licensing agreements and market strategies. However, companies with expertise in solid oral dosage forms, particularly combination products with precise hormone dosing, are sought after. These include:

• Perrigo Company plc: A major generic pharmaceutical manufacturer with extensive contract manufacturing services.
• Catalent, Inc.: A global leader in drug development and manufacturing solutions, including complex oral solid dosage forms.
• Thermo Fisher Scientific (Patheon): Offers a broad range of pharmaceutical development and manufacturing services.
• Major generic drug manufacturers: Companies like Teva Pharmaceutical Industries, Viatris Inc. (formed by the merger of Mylan and Pfizer's Upjohn business), and Sun Pharmaceutical Industries often have in-house manufacturing or established CMO relationships for their generic products.

The selection of CMOs is based on their ability to meet strict GMP standards, their experience with hormonal contraceptives, and their capacity to handle the specific tablet size and coating requirements of Lo Loestrin Fe. The ability to manage controlled substance regulations, where applicable, is also a factor.

What Are the Regulatory Considerations for Lo Loestrin Fe Suppliers?

Suppliers of APIs and finished dosage forms for Lo Loestrin Fe must comply with stringent regulatory requirements from agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others globally. Key considerations include:

• Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to current GMP (cGMP) standards. This includes robust quality management systems, validated processes, and thorough documentation.
• Drug Master Files (DMFs): API suppliers typically maintain DMFs with regulatory agencies. These confidential documents provide detailed information about the manufacturing process, quality control, and stability of the API.
• ICH Guidelines: Compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly Q7 for API GMP, Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality System, is essential.
• Impurity Profiling: Rigorous analysis and control of impurities, including genotoxic impurities, are critical for hormonal APIs.
• Site Inspections: Facilities are subject to routine inspections by regulatory authorities to ensure ongoing compliance.
• Controlled Substance Regulations: While the hormones in Lo Loestrin Fe are not typically scheduled as controlled substances in the same way as opioids or stimulants, their potent pharmacological activity means that manufacturing and distribution are closely monitored.

What Are the Potential Supply Chain Risks for Lo Loestrin Fe?

The supply chain for Lo Loestrin Fe faces several potential risks:

• API Availability and Quality: Dependence on a limited number of specialized API manufacturers for NA and EE creates vulnerability. Any disruption at a key supplier's facility (e.g., due to regulatory action, natural disaster, geopolitical instability) can impact global supply. Quality issues, such as batch failures or unexpected impurity profiles, can lead to recalls and shortages.
• Geopolitical Factors: A significant portion of API production for these hormones is concentrated in China and India. Trade disputes, export restrictions, or regional conflicts could disrupt the flow of materials.
• Regulatory Changes: Evolving regulatory requirements or new interpretations of existing rules can necessitate process changes or facility upgrades, leading to delays and increased costs. For example, stricter impurity limits could impact the viability of certain API batches.
• CMO Capacity and Performance: Reliance on contract manufacturers means that capacity constraints or performance issues at a CMO can affect production timelines and product availability. CMOs may also face their own supply chain challenges with excipients or packaging materials.
• Logistics and Transportation: The global nature of the supply chain requires robust logistics. Disruptions in shipping, customs delays, or increased freight costs can impact delivery schedules and profitability.
• Intellectual Property and Generic Competition: As patents expire, increased generic competition can lead to pricing pressures. This necessitates efficient supply chain management to maintain cost competitiveness. The market for low-dose oral contraceptives is highly competitive, with multiple generic versions available.
• Excipient Sourcing: While less critical than API sourcing, disruptions in the supply of high-quality excipients (fillers, binders, disintegrants) and packaging materials can also impact production.

What Are the Opportunities for Supply Chain Optimization?

Stakeholders in the Lo Loestrin Fe supply chain can pursue several optimization strategies:

• Dual Sourcing: Establishing relationships with at least two qualified suppliers for critical APIs (NA and EE) can mitigate the risk of single-source dependency. This requires significant investment in supplier qualification and validation.
• Geographic Diversification: Exploring API manufacturers in different geographic regions can reduce exposure to single-country risks. This might involve engaging with suppliers in Europe or North America, although cost implications need careful evaluation.
• Strategic Partnerships with CMOs: Developing strong, long-term relationships with CMOs can ensure dedicated capacity and prioritized production. Joint efforts in process improvement and risk management can yield mutual benefits.
• Vertical Integration: In some cases, brand owners might consider backward integration into API manufacturing for highly critical or high-volume components, although this is capital-intensive and requires specialized expertise.
• Supply Chain Transparency and Visibility: Implementing advanced supply chain management systems that provide real-time visibility into inventory levels, production status, and logistics can enable proactive problem-solving.
• Continuous Process Improvement: Working with API suppliers and CMOs to optimize manufacturing processes can lead to cost reductions, improved yields, and enhanced quality. This includes implementing lean manufacturing principles and advanced process control.
• Risk Assessment and Contingency Planning: Conducting regular, comprehensive risk assessments of the entire supply chain and developing detailed contingency plans for various disruption scenarios (e.g., API shortage, CMO shutdown) is essential.

Key Takeaways

The supply chain for Lo Loestrin Fe relies on a specialized network of API manufacturers for norethindrone acetate and ethinyl estradiol, with significant production capacity located in China and India. Ferrous fumarate is sourced from a broader range of chemical suppliers. Contract manufacturers with expertise in oral solid dosage forms play a crucial role in finished product formulation and packaging. Regulatory compliance, particularly adherence to cGMP and ICH guidelines, is paramount for all suppliers. Key risks include API availability and quality issues, geopolitical instability, regulatory changes, and CMO performance. Opportunities for optimization lie in dual sourcing, geographic diversification, strategic CMO partnerships, and enhanced supply chain visibility.

Frequently Asked Questions

1. Which countries are the primary sources for Norethindrone Acetate (NA) and Ethinyl Estradiol (EE) APIs used in Lo Loestrin Fe?

Primary sources for NA and EE APIs are concentrated in China and India, with some production also occurring in Europe by established pharmaceutical companies.

2. What regulatory filing is required from API suppliers for Lo Loestrin Fe?

API suppliers typically submit Drug Master Files (DMFs) to regulatory agencies like the FDA and EMA, detailing their manufacturing processes and quality controls.

3. How does the genericization of Lo Loestrin Fe impact its supplier landscape?

Genericization increases competition, leading to price pressures and a greater emphasis on cost-efficient supply chains. This may drive demand towards lower-cost API manufacturers and CMOs.

4. What is the typical shelf-life expectation for APIs used in Lo Loestrin Fe?

API shelf-lives for norethindrone acetate and ethinyl estradiol are generally between two to five years, depending on the specific API manufacturer's validation and stability studies, and are dictated by ICH guidelines.

5. Are there any specific challenges associated with sourcing ferrous fumarate for Lo Loestrin Fe?

Sourcing ferrous fumarate is generally straightforward due to its wide availability as a commodity chemical. Challenges, if any, would relate to ensuring consistent particle size distribution and low levels of specific metal impurities to meet pharmaceutical grade specifications.

Citations

[1] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from [Company website]

[2] Shandong Xinhua Pharmaceutical Co., Ltd. (n.d.). API Product List. Retrieved from [Company website]

[3] Cheman Pharmaceuticals Private Limited. (n.d.). Steroid Hormones. Retrieved from [Company website]

[4] Taj Pharmaceuticals Ltd. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company website]

[5] Amneal Pharmaceuticals. (n.d.). API Capabilities. Retrieved from [Company website]

[6] Gedeon Richter Plc. (n.d.). API Manufacturing. Retrieved from [Company website]

[7] Centrient Pharmaceuticals. (n.d.). Steroid Hormones Portfolio. Retrieved from [Company website]

[8] Foodchem International Corporation. (n.d.). Pharmaceutical Ingredients. Retrieved from [Company website]

[9] Xi'an Natural Field Bio-Technique Co., Ltd. (n.d.). Pharmaceutical Intermediates. Retrieved from [Company website]

[10] Sun Pharmaceutical Industries Ltd. (n.d.). API Capabilities. Retrieved from [Company website]

[11] Perrigo Company plc. (n.d.). Contract Manufacturing. Retrieved from [Company website]

[12] Catalent, Inc. (n.d.). Oral Delivery Solutions. Retrieved from [Company website]

[13] Thermo Fisher Scientific. (n.d.). Pharmaceutical Services. Retrieved from [Company website]

[14] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from [FDA website]

[15] European Medicines Agency. (n.d.). Manufacturing and Quality. Retrieved from [EMA website]

[16] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH website]