Suppliers and packagers for LOW-OGESTREL-28

LOW-OGESTREL-28

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Sa	LOW-OGESTREL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	075288	ANDA	Mayne Pharma Inc.	51862-564-06	6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)	2016-08-03

Suppliers for the Pharmaceutical Drug: LOW-OGESTREL-28

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape for hormonal contraceptives, such as Low-Ogestrel-28, presents a complex network of manufacturers, distributors, and regulatory navigators. Low-Ogestrel-28, a combination oral contraceptive combining levonorgestrel and ethinyl estradiol, is widely used for birth control and hormonal regulation. Its global availability hinges on licensed suppliers who meet stringent quality, safety, and efficacy standards established by regulatory agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national bodies.

Identifying the primary suppliers, including original manufacturers, generic producers, and authorized distributors, is essential for healthcare providers, pharmaceutical companies, and policymakers to ensure supply chain security, compliance, and patient safety.

Original Equipment Manufacturers (OEMs)

1. Hoe Pharmaceutical (South Korea)

Hoe Pharmaceutical is recognized for manufacturing a range of hormonal contraceptive products, including formulations similar or identical to Low-Ogestrel-28. As a Korean-based pharmaceutical producer, Hoe supplies APIs and finished dose forms compliant with international standards. Their manufacturing facilities are licensed by the Korean Ministry of Food and Drug Safety (MFDS) and adhere to Good Manufacturing Practices (GMP) [1].

2. Teva Pharmaceuticals (Israel)

Teva is a leading global generic pharmaceutical company with extensive capabilities in hormone-based medications. With a strong presence in North America, Europe, and emerging markets, Teva manufactures and markets generic versions of combined oral contraceptives similar to Low-Ogestrel-28. Their manufacturing facilities are certified by multiple regulatory agencies, ensuring product quality and consistency [2].

3. Sandoz (Novartis division, Switzerland)

Sandoz is a key player in the biosimilars and generics industry, producing hormonal contraceptives under various brand names. They supply high-quality formulations comparable to Low-Ogestrel-28 for regulated markets. Sandoz's manufacturing sites are GMP-compliant and adhere to Annex 1 standards of the EMA [3].

Generic Manufacturers and Licensed Suppliers

4. Mylan (Now part of Viatris)

Viatris, formed by the merger of Mylan and Pfizer’s Upjohn unit, provides a wide portfolio of oral contraceptives, including generic alternatives akin to Low-Ogestrel-28. Their manufacturing facilities in the US, India, and Europe ensure compliance with international quality systems [4].

5. Lupin Pharmaceuticals (India)

Lupin produces a broad spectrum of contraceptive products, with several formulations approved by the Indian drug regulator and exported globally. Their API manufacturing and finished product facilities follow USFDA and EMA standards, making them a significant supplier for generic forms of Low-Ogestrel-28 [5].

6. Aurobindo Pharma (India)

Aurobindo is recognized for its high-volume production of hormonal drugs, including oral contraceptives. Their facilities meet global regulatory requirements, and they supply to many international markets, providing high-quality generics comparable to Low-Ogestrel-28 [6].

7. Actavis (now part of Allergan, USA)

Actavis, historically a major producer of oral contraceptives, continues to supply affordable generic options globally. Their manufacturing capabilities extend to hormone-based therapies, with production sites compliant with USFDA and EMA requirements [7].

Distributors and Supply Chain Intermediaries

While manufacturing is concentrated among the above companies, distribution is managed through a network of licensed pharmaceutical distributors. Their responsibility includes regulatory compliance, quality assurance, and logistics management.

8. McKesson Corporation (USA)

As a leading distributor of pharmaceuticals, McKesson stocks a wide array of contraceptive products, including generics similar to Low-Ogestrel-28, ensuring wide availability across healthcare providers and pharmacies in North America [8].

9. Cardinal Health (USA)

Cardinal Health manages supply chains for reproductive health products, sourcing from licensed manufacturers and ensuring regulatory adherence, particularly for hospital and retail pharmacy channels [9].

10. Phoenix Pharma (India)

Phoenix Pharma provides distribution services for Indian generics manufacturers, including Lupin and Aurobindo. They play a critical role in regional markets, ensuring the supply of Low-Ogestrel-28 equivalents in Asia and Africa [10].

Regulatory and Quality Assurance Considerations

Suppliers for Low-Ogestrel-28 must comply with pharmacopoeial standards and regulatory approvals. Certification by agencies such as USFDA, EMA, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is pivotal. Suppliers must also adhere to Good Manufacturing Practices (GMP), and their products should meet bioequivalence and stability criteria to ensure therapeutic consistency.

Market Dynamics and Strategic Implications

The supply landscape for Low-Ogestrel-28 is influenced by patent expirations, regulatory approvals, and manufacturing capacity. With patent protection for original formulations expiring in various regions, the number of generic manufacturers has expanded, increasing competition and lowering prices. However, geopolitical factors, patent litigations, and supply chain disruptions (e.g., during the COVID-19 pandemic) impact the availability and consistency of supplies.

Strategic partnerships and licensing agreements between originators and generic manufacturers often facilitate market access. Additionally, quality assurance and regulatory compliance remain recurring hurdles that suppliers must navigate to ensure continued market presence.

Conclusion

The supply chain for Low-Ogestrel-28 involves a well-established ecosystem of original equipment manufacturers, generic producers, and reliable distributors. Leading pharmaceutical companies such as Hoe Pharmaceutical, Teva, Sandoz, Viatris, Lupin, Aurobindo, and Actavis form the core of approved suppliers, supported by distribution giants like McKesson, Cardinal Health, and Phoenix Pharma.

Ensuring the integrity of the supply chain hinges on regulatory compliance, manufacturing quality, and logistics efficiency. Stakeholders should prioritize partnerships with GMP-certified manufacturers and monitor regulatory developments to secure reliable access to this critical contraceptive.

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Key Takeaways

• The primary suppliers of Low-Ogestrel-28 include global generic pharmaceutical companies such as Teva, Sandoz, Lupin, and Aurobindo.
• Original manufacturers like Hoe Pharmaceutical contribute to manufacturing robust API and finished dosage forms, especially in Asian markets.
• Distribution partners like McKesson and Cardinal Health facilitate wide geographic availability, ensuring accessibility.
• Regulatory compliance (USFDA, EMA) and GMP standards are critical for supplier credibility and product quality.
• The evolving generic market, patent expirations, and regulatory landscapes influence supplier strategies and product availability.

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FAQs

Q1: Is Low-Ogestrel-28 available as a generic in all markets?
A1: Availability varies by region. Many markets have approved generic versions produced by companies like Teva, Lupin, and Aurobindo, but some jurisdictions primarily rely on the brand-name formulation or local generics.

Q2: How can healthcare providers verify the legitimacy of a Low-Ogestrel-28 supplier?
A2: Providers should verify that suppliers are licensed and their products are approved by relevant regulatory agencies (e.g., USFDA, EMA). Certification documents, batch traceability, and GMP compliance reports are vital.

Q3: What are the risks associated with sourcing Low-Ogestrel-28 from unverified suppliers?
A3: Risks include substandard quality, incorrect dosing, contamination, and potential legal issues. Unverified sources may also lack regulatory approval, compromising safety.

Q4: Are there significant differences in efficacy among various suppliers for Low-Ogestrel-28?
A4: As long as the products meet approved specifications and are bioequivalent, efficacy should be comparable. Regulatory approvals ensure consistency across manufacturers.

Q5: How does patent expiry influence supplier options for Low-Ogestrel-28?
A5: Patent expirations open the market to multiple generic manufacturers, increasing competition, reducing costs, and expanding access. However, the timing of patent expiry varies by jurisdiction.

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Sources

[1] Hoe Pharmaceutical. (2022). Corporate Brochure.
[2] Teva Pharmaceuticals. (2023). Product Portfolio Overview.
[3] Sandoz. (2022). Quality and Compliance Standards.
[4] Viatris. (2023). Global Contract Manufacturing.
[5] Lupin Pharmaceuticals. (2022). API and Finished Drugs.
[6] Aurobindo Pharma. (2023). Global Regulatory Approvals.
[7] Allergan. (2021). Generics Portfolio.
[8] McKesson Corporation. (2022). Pharmaceutical Distribution Overview.
[9] Cardinal Health. (2022). Supply Chain Management.
[10] Phoenix Pharma. (2021). Distribution Networks in Asia and Africa