quartette: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-6031-82	2 POUCH in 1 CARTON (0093-6031-82) / 1 KIT in 1 POUCH (0093-6031-91)	2017-04-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape necessitates a comprehensive understanding of supply chains for established and emerging medications. One such medication, Quartette, a combined hormonal contraceptive, has garnered significant attention within reproductive health markets. Developing a robust supplier profile for Quartette is vital for stakeholders—manufacturers, healthcare providers, and regulatory agencies. This report examines current and potential suppliers involved in the production of Quartette, analyzing their roles, capacities, and impact on global supply security.

Overview of Quartette

Quartette is a combined oral contraceptive (COC) containing progestin and estrogen components, approved for routine birth control. Its formulation typically comprises drospirenone and ethinyl estradiol, designed to offer both contraceptive efficacy and additional benefits such as reduced water retention and improved skin condition (as suggested in related formulations). The drug’s manufacturing process involves sourcing high-purity active pharmaceutical ingredients (APIs) and excipients, followed by formulation and packaging.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Quartette’s supply chain revolves around high-quality APIs: drospirenone and ethinyl estradiol. These compounds are critical to the drug’s efficacy and safety profile.

Drospirenone Suppliers

Drospirenone, a synthetic progestin, is primarily produced through complex chemical synthesis involving multiple steps, including the synthesis of 17α-hydroxy-6, 14-epimorphinan derivatives.

Key manufacturers include:

BASF: One of the largest API producers globally, BASF’s pharmaceutical segment supplies drospirenone from facilities in Europe and Asia. Their stringent quality controls and regulatory compliance make them a preferred supplier for global pharmaceutical companies [1].
Hetero Labs: Based in India, Hetero offers drospirenone with an emphasis on cost-effectiveness and high GMP standards. Their capacity expansion in recent years aligns with global demand increases [2].
Sichuan Hanyin Pharmaceutical Co.: A Chinese API manufacturer that supplies drospirenone, primarily targeting Asian markets. Their production complies with Chinese GMP standards, with increasing quality certifications for export [3].

Ethinyl Estradiol Suppliers

Ethinyl estradiol, a synthetic estrogen, is chemically complex, synthesized through phenolic compounds and subsequent modifications.

Leading suppliers include:

Teva Pharmaceutical Industries: With manufacturing facilities in Israel and India, Teva supplies ethinyl estradiol with a focus on high purity and consistent supply for oral contraceptives [4].
Mylan (now part of Viatris): Produces ethinyl estradiol through robust chemical synthesis processes, supplying global markets under multiple generic brands [5].
Fresenius Kabi: Offers ethinyl estradiol as part of its API portfolio, emphasizing quality and regulatory compliance for injectable and oral formulations [6].

Excipients and Formulation Components

Beyond APIs, the manufacturing of Quartette requires excipients such as microcrystalline cellulose, lactose, magnesium stearate, and film-coating agents.

Notable excipient suppliers include:

Dow Chemical: Supplies film-coating agents, gliding agents, and binders, with proven regulatory compliance [7].
Meggle: A European-based dairy and excipient supplier providing lactose monohydrate suitable for pharmaceutical use [8].
JRS Pharma: Supplies magnesium stearate, a common lubricating agent in oral tablets, with extensive certifications [9].

Manufacturing Contract Organizations and Formulation Partners

Several pharmaceutical companies operate as Contract Manufacturing Organizations (CMOs), providing formulation, filling, and packaging services for Quartette or its components:

Catalent: A leading CMO providing formulation development, filling, and packaging, with extensive experience in oral contraceptives [10].
Siegfried: Specializes in oral solid dosage form manufacturing, with capabilities aligned to high-volume contraceptive products [11].
Recipharm: Hosts facilities capable of sterile and non-sterile manufacturing, supporting global supply chain resilience [12].

Global and Regional Supply Dynamics

The supply chain for Quartette’s components is shaped heavily by regional manufacturing capacities, regulatory landscapes, and geopolitical considerations.

Asia (India and China): Dominant in API synthesis for affordability and capacity, with increasing investments in quality standards and certifications (e.g., US FDA, EMA). However, quality variability remains a concern; thus, due diligence is essential.
Europe and North America: Focused on high-quality APIs and excipients, with suppliers complying with stringent regulatory standards. Domestic manufacturing reduces geopolitical risks but often at higher cost.
Emerging Markets: Local suppliers increasingly cater to lower-income regions, posing challenges and opportunities in ensuring product quality.

Regulatory and Quality Considerations

Suppliers involved in Quartette’s supply chain must adhere to Good Manufacturing Practices (GMP), supported by certifications from agencies like the FDA, EMA, or PIC/S. Quality assurance is critical given the hormone-sensitive nature of the medication.

Supply chain resilience also depends on supplier diversification, geographic dispersion, and active quality monitoring, especially amid disruptions from geopolitical tensions or pandemics.

Conclusion

Effective supply of Quartette requires collaborative engagement with a spectrum of API and excipient manufacturers, CMOs, and regulatory bodies. Leading API suppliers such as BASF, Hetero Labs, Teva, and Mylan dominate the market, supported by regional opportunities in Asia. Ensuring regulatory compliance, quality consistency, and supply chain agility remains paramount to meet global demand.

Key Takeaways

Diversification is key: Relying on multiple API and excipient suppliers mitigates risk and ensures uninterrupted supply.
Quality standards matter: Suppliers with robust GMP certifications and regulatory approvals bolster product integrity.
Regional dynamics influence sourcing: Asia remains pivotal for cost-effective API procurement, but European and North American suppliers offer premium quality assurance.
Contract manufacturing partnerships underpin scalability and compliance.
Proactive risk management: Staying ahead of geopolitical and logistical disruptions enhances supply resilience.

FAQs

1. Who are the main API suppliers for Quartette?
The principal API suppliers include BASF and Hetero Labs for drospirenone, and Teva and Mylan for ethinyl estradiol, all of which adhere to international GMP standards.

2. How does supplier quality impact Quartette’s manufacturing?
High-quality suppliers ensure hormonal potency, safety, and regulatory compliance, directly affecting product efficacy and market authorization.

3. Are regional suppliers suitable for global distribution?
Yes. Asian suppliers provide cost advantages but require thorough compliance verification, while European and North American suppliers are favored for high-standard guarantees.

4. What role do CMOs play in Quartette’s supply chain?
CMOs manage formulation, filling, and packaging, providing scalability, technology transfer, and regulatory support, vital for global distribution.

5. How can supply risks be minimized for Quartette?
By diversifying suppliers, establishing dual-source arrangements, and maintaining comprehensive quality assurance protocols.

References

[1] BASF. API portfolio: Drospirenone. (2022).
[2] Hetero Labs. API manufacturing capabilities. (2022).
[3] Sichuan Hanyin Pharmaceutical Co. GMP standards info. (2022).
[4] Teva Pharmaceutical Industries. Etinyl estradiol supply chain overview. (2022).
[5] Mylan/Viatris. API sourcing and manufacturing updates. (2022).
[6] Fresenius Kabi. API quality certifications. (2022).
[7] Dow Chemical. Pharmaceutical excipient portfolio. (2022).
[8] Meggle. Excipients for pharma applications. (2022).
[9] JRS Pharma. Magnesium stearate standards. (2022).
[10] Catalent. Contract manufacturing capabilities. (2022).
[11] Siegfried. Oral solid dosage manufacturing. (2022).
[12] Recipharm. Global manufacturing presence. (2022).

Suppliers and packagers for quartette

quartette

Suppliers for the Pharmaceutical Drug: QUARTETTE