Suppliers and packagers for CLIMARA PRO

CLIMARA PRO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-491-04	4 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH	2003-11-21
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-491-73	1 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH	2003-11-21

Suppliers for the Pharmaceutical Drug: CLIMARA PRO

Last updated: August 21, 2025

Introduction

CLIMARA PRO is a combined hormone replacement therapy (HRT) patch formulated specifically for the treatment of menopausal vasomotor symptoms and genitourinary syndrome of menopause. Produced by Bayer Schering Pharma AG, CLIMARA PRO delivers a combination of estradiol and levonorgestrel via transdermal patches. Its unique formulation and delivery system have established it as a prominent player in the menopausal treatment landscape. Ensuring supply chain stability and understanding key suppliers' roles are crucial for healthcare providers, pharmacies, and pharmaceutical distributors. This article explores the primary stakeholders involved in supplying CLIMARA PRO, the manufacturing and distribution networks, and the regulatory environment underpinning its availability.

Manufacturing Sources of CLIMARA PRO

Bayer Schering Pharma AG: The Original Manufacturer

Bayer Schering Pharma, a subsidiary of Bayer AG, is the primary manufacturer of CLIMARA PRO. As a global science-led healthcare company headquartered in Germany, Bayer maintains extensive facilities dedicated to the research, development, and production of hormonal therapies, including transdermal patches. The core manufacturing facility for CLIMARA PRO is located in Germany, leveraging Bayer's advanced pharmaceutical manufacturing infrastructure that complies with Good Manufacturing Practices (GMP) under European Medicines Agency (EMA) regulations [1].

Production Process and Quality Control

Manufacturing CLIMARA PRO involves complex processes including the synthesis of estradiol and levonorgestrel, formulation of the patch matrix, and precise layering of drug-containing membranes. Bayer employs rigorous quality control measures at each stage, from raw material acquisition to final packaging, ensuring compliance with international standards such as GMP and ISO certifications [2].

Raw Material Suppliers

The key raw materials — estradiol and levonorgestrel — are sourced from specialized chemical suppliers. These active pharmaceutical ingredients (APIs) are procured from global suppliers known for producing pharmaceutical-grade compounds. The reliability of these raw material suppliers is critical, given the stringent quality norms and batch-to-batch consistency required in hormone therapies.

• Estradiol API providers include companies such as Provenance Bio and Cambridge Isotope Laboratories.
• Levonorgestrel API providers include Watson Pharma (a division of Teva) and Siegfried AG.

Raw material sourcing is subjected to validation, with Bayer and other stakeholders conducting audits to verify compliance with GMP standards. Supplier qualification processes involve comprehensive documentation review, site audits, and analytical testing of raw materials before acceptance.

Supply Chain and Distribution Networks

Regional Distributors

Once manufactured, CLIMARA PRO is distributed through a network of regional and national wholesalers. These distributors include large pharmaceutical distribution companies such as McKesson Corporation, Cardinal Health, and AmerisourceBergen, which facilitate the drug's reach to pharmacies, hospitals, and clinics. Bayer collaborates with these entities to maintain inventory levels and streamline logistics.

Pharmacy and Hospital Supply

Pharmaceutical wholesalers supply CLIMARA PRO to retail pharmacies, specialty clinics, and hospital-based pharmacies. Distribution logistics are managed to ensure the cold chain integrity (if required) and timely replenishment across various markets.

Regional Market Dynamics

The drug is marketed extensively across North America, Europe, Australia, and select Asian countries. Each regional market involves specific regulatory pathways and distribution mandates. For example, in the U.S., CLIMARA PRO is prescribed based on FDA approvals and is distributed via established pharmaceutical wholesalers. In Europe, EMA approvals govern its availability, with distribution managed through a network of authorized pharmacies.

Regulatory and Licensing Approvals

Regulatory Affiliates and Approvals

Bayer's regulatory affairs teams secure drug approvals, manufacturing licenses, and post-marketing authorizations. Regulatory bodies such as the EMA, the U.S. FDA, and respective national agencies authorize the sale of CLIMARA PRO based on comprehensive dossier evaluations including clinical data, manufacturing quality, and safety profiles.

Generic and Biosimilar Suppliers

While Bayer holds the original patent and exclusive rights, some markets may eventually see generic versions or biosimilars. These are developed by third-party companies that may obtain licensing agreements or approval from Bayer or regulatory agencies for generic equivalents. Currently, no approved biosimilars or generics directly compete with CLIMARA PRO's specific formulation in major markets.

Critical Challenges in Supply

• Regulatory Variations: Different countries’ regulatory requirements can create delays in approval and supply continuity.
• Raw Material Supply Chain Disruptions: Limited suppliers for APIs may lead to procurement bottlenecks, affecting production.
• Manufacturing Capacity Constraints: Bayer’s production capacity may influence global supply levels, especially amid increased demand or supply chain disruptions like geopolitical tensions or pandemics.
• Market-Specific Regulatory Approvals: Varying approval timelines and requirements may impact supply consistency in emerging markets.

Future Outlook

Bayer’s strategic partnerships with raw material producers and investments in manufacturing capacity expansion aim to mitigate supply risks. Additionally, collaborations with regional distributors facilitate localized procurement solutions. The potential development of biosimilar competitors or alternative delivery systems could influence the supply landscape in the coming years.

Key Takeaways

• Primary manufacturer: Bayer Schering Pharma AG, with production facilities in Germany adhering to strict GMP standards.
• Supply chain: Managed through global pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen, ensuring availability across markets.
• Raw material sourcing: Involves specialized, pharmaceutical-grade API suppliers with rigorous validation processes.
• Regulatory environment: Critical in shaping supply continuity, with approvals from EMA, FDA, and national agencies influencing market access.
• Supply challenges: Include raw material scarcity, capacity constraints, and regulatory variations, necessitating strategic inventory and supply chain management.

FAQs

1. Who are the primary raw material suppliers for CLIMARA PRO?
Key suppliers for estradiol and levonorgestrel APIs include Provenance Bio, Cambridge Isotope Laboratories, Watson Pharma (Teva), and Siegfried AG, all of which produce pharmaceutical-grade hormones under strict GMP conditions.

2. How does Bayer ensure the quality of CLIMARA PRO throughout its supply chain?
Bayer employs comprehensive quality management protocols, from rigorous supplier qualification processes to in-house quality control testing at manufacturing sites, ensuring consistent product safety and efficacy.

3. What role do distribution companies play in the availability of CLIMARA PRO?
Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen facilitate regional stock management, logistics, and supply chain optimization, ensuring timely access to pharmacies and hospitals.

4. Are there any generic alternatives to CLIMARA PRO?
As of now, Bayer holds exclusive rights to CLIMARA PRO in major markets, and no approved generics or biosimilars directly compete with it, although future developments may alter this landscape.

5. What challenges could potentially disrupt the supply of CLIMARA PRO?
Disruptions can stem from raw material shortages, geopolitical issues affecting manufacturing, regulatory delays, or capacity limitations within Bayer's production facilities.

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References

[1] Bayer AG. (2022). Corporate governance and manufacturing standards. Bayer Annual Report.
[2] European Medicines Agency. (2021). Guideline on Good Manufacturing Practices. EMA.