LARIN 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
Novast Labs	LARIN FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	091453	ANDA	Northstar Rx LLC	16714-405-01	1 BLISTER PACK in 1 PACKET (16714-405-01) / 1 KIT in 1 BLISTER PACK	2013-08-23
Novast Labs	LARIN FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	091453	ANDA	Northstar Rx LLC	16714-405-02	1 BLISTER PACK in 1 CARTON (16714-405-02) / 1 KIT in 1 BLISTER PACK	2013-08-23
Novast Labs	LARIN FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	091453	ANDA	Northstar Rx LLC	16714-405-03	3 BLISTER PACK in 1 CARTON (16714-405-03) / 1 KIT in 1 BLISTER PACK	2013-08-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

LARIN FE 1.5/30 is a combination oral contraceptive formulated with levonorgestrel (1.5 mg) and ethinyl estradiol (30 mcg). Widely prescribed for birth control and hormone regulation, this medication's demand depends heavily on its reliable supply chain. Identifying the primary suppliers—manufacturers, authorized distributors, and licensed generic producers—is vital for stakeholders in pharmaceutical procurement, healthcare providers, and distributors seeking consistent and compliant drug sourcing.

This report delineates current key suppliers, market dynamics, regulatory considerations, and factors influencing supply stability for LARIN FE 1.5/30, empowering decision-makers with comprehensive insights.

Manufacturers of LARIN FE 1.5/30

1. Original Innovator License Holders

The foundational formulation of LARIN FE 1.5/30 was developed by major pharmaceutical companies specializing in hormonal contraceptives. Prominent among these are:

Bayer AG: Known for its contraceptive products, Bayer has historically been a significant producer of combination oral contraceptives, including formulations similar to LARIN FE.
Gedeon Richter Plc: A leading Hungarian pharmaceutical company with a robust portfolio in hormonal therapies, Gedeon Richter manufactures and markets several oral contraceptive formulations domestically and internationally.
Teva Pharmaceutical Industries Ltd.: As one of the world's largest generic drug manufacturers, Teva produces bioequivalent versions of many contraceptives and may license or produce LARIN FE 1.5/30 under different brands or formulations depending on regional approvals.

2. Generic Manufacturers

Due to patent expirations and regional licensing, several generic pharmaceutical companies manufacture LARIN FE 1.5/30 or equivalent formulations. These include:

Hovid Inc. (Malaysia): Known for generic reproductive health medications, they produce oral contraceptives with similar active ingredients.
Pfizer Inc.: Although Pfizer divested its contraceptive portfolio in some regions, certain generic formulations continue under its licensing agreements.
Sandoz (a Novartis division): Operates as a major producer of generic contraceptive pills, including combinations similar to LARIN FE 1.5/30.
MediGene Pharmaceuticals: Produces regional generics compliant with local regulations, supplying both branded and generic contraceptive products.

The proliferation of generic manufacturers increases market competition, often leading to more accessible pricing and improved supply resilience.

Authorized Distributors and Market Dynamics

Global Distribution Channels

LARIN FE 1.5/30's distribution hinges on licensed distributors authorized by the patent holders or manufacturing companies. Distributors often operate under strict regulatory oversight, ensuring product authenticity and compliance with regional standards.

Key authorized distributors include:

Pharmaceutical wholesalers affiliated with Bayer, Gedeon Richter, or Teva, supplying regional pharmacies and hospitals.
Regional distributors and importers in emerging markets where local licenses permit the sale of imported or locally manufactured generics.
Online pharmacy platforms (regulated) that source products directly from licensed manufacturers for digital sales, increasingly common in regions with robust pharmaceutical e-commerce.

Supply Chain Considerations

Supply stability depends on several factors:

Regulatory approvals: Changes in registration status or licensing can impact availability.
Manufacturing capacity: Capacity constraints or disruptions (due to COVID-19 or other factors) can lead to shortages.
Regional market demand: Fluctuations influence production volumes and inventory levels.
Intellectual property rights: Patent expirations facilitate generic competition, benefitting supply and affordability.

Regulatory Environment and Licensing

Regulatory Agencies

Approval and registration of LARIN FE 1.5/30 vary per region:

United States: Marketed under brand or generic names following FDA approval; patent status influences suppliers.
European Union: Approved via EMA; multiple generics compete under strict compliance.
Asia, Africa, Latin America: Regulatory acceptance depends on local agencies like PMDA (Japan), CDSCO (India), ANVISA (Brazil), etc.

Quality Assurance

Suppliers must adhere to regional Good Manufacturing Practices (GMP). The World Health Organization (WHO) prequalification program and certifications issued by national agencies serve as benchmarks for supplier credibility.

Market Trends and Future Outlook

Growing demand: Increased awareness and acceptance of oral contraceptives drive consistent demand for LARIN FE 1.5/30 globally.
Patent expiration: Anticipated patent expiry timelines in key markets like the EU and USA will likely enhance generic supply diversification.
Supply Chain Consolidation: Larger pharmaceutical firms aim for robust manufacturing capacity and strategic partnerships to ensure uninterrupted supply.
Regional Generics Development: Emerging markets see an increase in local manufacturing respecting regional regulatory standards, expanding supplier options.

Key Factors for Stakeholders

Verification of supplier credentials: Ensuring product authenticity through licensing, GMP compliance, and regulatory approval.
Monitoring patent and exclusivity status: To anticipate generic entry and formulary decisions.
Assessing regional logistic capabilities: For timely procurement and distribution.
Building diversified supplier portfolios: To mitigate geopolitical, manufacturing or regulatory risks.

Key Takeaways

Major global suppliers include Bayer, Gedeon Richter, and Teva, with numerous regional generic manufacturers augmenting supply.
Regulatory approval and licensing are vital to ensure quality and compliance, with different agencies overseeing market entry.
Patent expirations and regional licensing foster an increasingly competitive generic market, improving availability and pricing.
Supply chain resilience depends on manufacturing capacity, regulatory stability, and strategic distribution networks.
Stakeholders should routinely verify supplier credentials, stay informed about patent timelines, and diversify sources to ensure consistent access.

FAQs

Who are the primary global manufacturers of LARIN FE 1.5/30?
Major producers include Bayer AG, Gedeon Richter, and Teva Pharmaceutical Industries, with additional regional generics from companies like Sandoz.
How can I verify the authenticity of LARIN FE 1.5/30?
Confirm registration with local health authorities, check for GMP certification, and purchase from authorized distributors.
Are generic versions of LARIN FE 1.5/30 available?
Yes, multiple generic manufacturers produce bioequivalent formulations, often at lower costs and with wider regional availability.
What factors influence the supply stability of LARIN FE 1.5/30?
Manufacturing capacity, regulatory approvals, patent status, regional demand, and geopolitical factors.
How will patent expirations impact the market?
Patent expirations open the market to more generic manufacturers, increasing supply, reducing prices, and enhancing access.

References

[1] European Medicines Agency (EMA). (2022). Contraceptive medications approval and regulation.
[2] FDA Drug Approvals & Approvals Process. (2023). Generic contraceptive drugs.
[3] World Health Organization (WHO). (2021). Prequalification of reproductive health medicines.
[4] Gedeon Richter Official Website. (2023). Product portfolio.
[5] Sandoz, Novartis Official Communications. (2022). Generic contraceptive manufacturing.

Suppliers and packagers for LARIN FE 1.5/30

LARIN FE 1.5/30

Suppliers for the Pharmaceutical Drug: LARIN FE 1.5/30