SKYLA: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-422-01	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)	2013-01-11
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-422-08	1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)	2013-01-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

SKYLA (levonorgestrel-releasing intrauterine system) is a long-acting, reversible contraceptive device primarily used for birth control and to manage heavy menstrual bleeding. Approved by the FDA in 2013, SKYLA is a product of Bayer, a global healthcare and pharmaceutical company known for its leadership in reproductive health. As with most complex pharmaceutical products, SKYLA's distribution depends on an intricate web of suppliers, including raw material producers, manufacturing facilities, and distribution channels. Understanding these suppliers is vital for stakeholders across the supply chain—from healthcare providers to investors seeking insight into market competition and supply security.

Manufacturing and Supply Chain Overview

1. Bayer Healthcare and Contract Manufacturers

Bayer Pharmaceuticals is the primary manufacturer of SKYLA, overseeing its formulation, quality control, and packaging. To meet global demand, Bayer relies on a network of contract manufacturing organizations (CMOs). These CMOs often operate in different regions, ensuring compliance with local regulatory standards and enabling rapid distribution.

Bayer's strategic decisions involve engaging with CMOs like Catalent, Patheon (a part of Thermo Fisher Scientific), and Patheon, which possess the facilities capable of producing intrauterine devices (IUDs) at scale while upholding stringent quality requirements. These CMOs supply the sterile, pre-loaded SKYLA devices for distribution worldwide.

2. Raw Materials and Components

The production of SKYLA requires multiple raw materials, primarily:

Levonorgestrel: The active pharmaceutical ingredient (API) encapsulated within the IUD. It is synthesized through complex chemical processes involving precursors like ethinylestradiol or similar steroids.
Polymers and Elastomers: The drug delivery system incorporates biocompatible polymers, such as polyethylene or silicone elastomers, forming the inserter and IUD structure.
Packaging Components: Sterile liners, syringes, and packaging materials, often supplied by specialized vendors, must adhere to international quality standards.

3. Key Suppliers for Raw Materials

Levonorgestrel Suppliers: The API is sourced from specialized chemical manufacturers, which include global players like Novartis, Mitsubishi Tanabe Pharma, and Glenmark Pharmaceuticals. These companies produce levonorgestrel under strict regulatory oversight, providing APIs in bulk quantities to pharmaceutical manufacturers.
Polymer and Elastomer Providers: Suppliers such as Dow Chemical, BASF, or Evonik provide medical-grade polymers and elastomers used in SKYLA's construction. These materials must meet specific biocompatibility standards set by ISO and pharmacopoeias.
Sterile Packaging Suppliers: Companies like West Pharmaceutical Services and Gerresheimer supply the sterile packaging components, ensuring patient safety and product integrity.

Regulatory and Supply Chain Challenges

Supply Chain Dependencies: The reliance on single-source suppliers for critical APIs like levonorgestrel amplifies risk. Disruptions—due to geopolitical issues, manufacturing contamination, or capacity limitations—could impact SKYLA's global availability.

Regulatory Compliance: Suppliers must adhere to stringent Good Manufacturing Practices (GMP) stipulated by authorities like the FDA, EMA, and other regulators. Any deviation can lead to delays or product recalls.

Quality Control: Consistency in raw material quality is essential to prevent adverse reactions or efficacy issues, meaning suppliers undergo rigorous audits and inspections.

Major Suppliers and Market Dynamics

Although Bayer predominantly manages the manufacturing of SKYLA, the active pharmaceutical ingredient’s suppliers are key to ensuring a reliable supply chain. Industry reports suggest that:

Levonorgestrel APIs are often sourced from multiple manufacturers to mitigate supply risk. While specific contracts are proprietary, known API suppliers involved in reproductive health drugs include Novartis (via its Sandoz division), Mitsubishi Tanabe, and Glenmark.
For raw materials like polymers, Dow Chemical and BASF are leaders in medical-grade polymers used across multiple contraceptive devices, including SKYLA.
Additionally, Bayer has been investing in diversifying its supplier base and expanding manufacturing capacity for APIs to reduce dependence on any single source.

Market Entry of Competitors: As newer intrauterine systems (IUS) enter the market, suppliers of raw materials face increased competition, influencing prices and availability.

Supply Chain Strategies and Trends

Vertical Integration: Bayer has historically maintained close relationships with key raw material suppliers, with efforts toward vertical integration to secure supply lines.
Supply Chain Transparency: Increasing regulatory pressure encourages transparency in sourcing and manufacturing practices to ensure product safety.
Regional Manufacturing: To counteract supply disruptions, manufacturers are establishing regional production facilities, notably in Europe, North America, and Asia.
Innovation in API Production: Advances in green chemistry and API synthesis aim to reduce dependency on complex precursors, potentially diversifying the supplier base.

Conclusion

The supply chain for SKYLA is a multifaceted network involving raw material suppliers, contract manufacturers, and advanced packaging providers. While Bayer maintains primary control over manufacturing, critical inputs like levonorgestrel are sourced from specialized chemical producers, with a tendency toward diversification to mitigate risks. The integrity of this supply chain directly influences SKYLA's availability and pricing, making supplier relationships and regulatory compliance essential components of the overall market stability.

Key Takeaways

Bayer predominantly manages SKYLA manufacturing, leveraging a network of contract manufacturers and raw material suppliers.
The active pharmaceutical ingredient, levonorgestrel, is supplied by global API manufacturers such as Novartis and Mitsubishi Tanabe.
Raw materials like polymers and packaging components are supplied by major chemical companies emphasizing quality and regulatory compliance.
Supply chain resilience hinges on diversification of suppliers, regional manufacturing, and technological innovations in API production.
Regulatory standards and quality controls are critical to maintaining a reliable supply, especially amid geopolitical or global health disruptions.

FAQs

1. Who are the primary suppliers of levonorgestrel for SKYLA?
While specific contractual details are proprietary, major suppliers of levonorgestrel APIs globally include Novartis, Mitsubishi Tanabe Pharma, and Glenmark Pharmaceuticals, all adhering to strict regulatory standards.

2. Does Bayer use contract manufacturing organizations (CMOs) for SKYLA?
Yes. Bayer collaborates with CMOs such as Catalent and Thermo Fisher Scientific’s Patheon to manufacture SKYLA, ensuring scalable and compliant production.

3. How does supply chain diversification impact SKYLA’s market stability?
Diversification reduces dependency on single suppliers, mitigating risks of shortages, delays, or quality issues, thus ensuring consistent product availability globally.

4. What role do raw material suppliers play in regulatory compliance?
Suppliers must meet GMP standards and provide traceability, ensuring the API and components meet safety and efficacy requirements set by agencies like FDA and EMA.

5. Are there recent trends impacting SKYLA's supply chain?
Yes. Trends include regional manufacturing expansion, technological advancements in API synthesis, and increased scrutiny of supply chain transparency to address geopolitical and pandemic-related disruptions.

Sources:

[1] Bayer Pharmaceuticals. “SKYLA (Levonorgestrel-Releasing Intrauterine System).” Bayer website, 2022.
[2] U.S. Food and Drug Administration. “Skyla (levonorgestrel-releasing intrauterine system) Information.” FDA, 2013.
[3] Pharmaceutical Technology. “Top API Suppliers for Reproductive Health Drugs.” 2021.
[4] Dow Chemical and BASF official websites detailing medical-grade polymers.
[5] Industry reports on global intrauterine device markets and supply chain strategies.

Suppliers and packagers for SKYLA

SKYLA

Suppliers for the Pharmaceutical Drug: SKYLA