Share This Page
Suppliers and packagers for COMBIPATCH
✉ Email this page to a colleague
COMBIPATCH
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870 | NDA | Noven Therapeutics, LLC | 68968-0514-8 | 8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH | 1998-08-07 |
| Noven Pharms Inc | COMBIPATCH | estradiol; norethindrone acetate | FILM, EXTENDED RELEASE;TRANSDERMAL | 020870 | NDA | Noven Therapeutics, LLC | 68968-0525-8 | 8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH | 1998-08-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COMBIPATCH
Introduction
COMBIPATCH, a transdermal patch-based medication, is designed to deliver therapeutic agents directly through the skin, providing patients with a convenient and effective alternative to oral or injectable therapies. As with any pharmaceutical product, the supply chain comprises multiple stakeholders responsible for manufacturing, sourcing raw materials, quality assurance, and distribution. Understanding the current landscape of suppliers involved in COMBIPATCH production is crucial for pharmaceutical companies, investors, and regulatory bodies aiming to ensure consistent supply, compliance, and quality.
Overview of COMBIPATCH Composition
COMBIPATCH formulations vary depending on therapeutic indication, but typically include active pharmaceutical ingredients (APIs), adhesive matrices, permeation enhancers, backing layers, and protective liners. Its manufacturing process involves complex sourcing of raw materials and component parts, often requiring specialized suppliers capable of adhering to strict Good Manufacturing Practices (GMP).
Key Suppliers in the COMBIPATCH Supply Chain
1. Active Pharmaceutical Ingredient (API) Suppliers
The efficacy of COMBIPATCH depends heavily on the quality and stability of the API integrated into the patch.
-
Major Global API Manufacturers:
Leading suppliers include multinational corporations such as Pfizer, Novartis, and Pfizer’s API production units, which provide high-purity APIs tailored for transdermal delivery. These suppliers leverage advanced synthesis and purification techniques to ensure biocompatibility and potency. -
Specialized API Suppliers:
Smaller firms like Hikal Ltd., CordenPharma, and GlycoSyn offer specialized APIs relevant for patches, including steroids, analgesics, or hormonal compounds. Their focus on continuous process improvement helps ensure reliable supply and regulatory compliance.
2. Adhesive and Permeation Enhancer Suppliers
Adhesive components and permeation enhancers are critical for skin adherence and drug delivery efficiency.
-
Adhesive Manufacturers:
Companies like 3M, Nitto Denko, and Mondi produce medical-grade adhesives compatible with transdermal systems. These suppliers develop skin-friendly, hypoallergenic adhesives tailored to drug and patch specifications. -
Permeation Enhancer Providers:
Firms such as Primex and Ackerman supply chemical agents that facilitate better drug permeation. Their products must pass rigorous safety and compatibility testing to prevent skin irritation or adverse reactions.
3. Backing Layer and Protective Film Suppliers
The physical integrity and aesthetic of COMBIPATCH depend on durable backing materials.
-
Material Suppliers:
Hoechst, DuPont, and 3M supply backing films made from polyurethane, polyethylene, or polyester films. These materials are designed to withstand external factors and maintain drug stability. -
Protective Liners:
The peel-off liners are sourced from companies like Autajon and Cryovac, providing silicone-coated or polymer-based sheets that facilitate easy application and removal.
4. Packaging and Distribution Component Suppliers
Robust packaging ensures product stability for transportation and storage.
- Packaging Materials:
Suppliers such as Berry Global and Amcor provide sterile, tamper-evident blister packs and pouches aligning with regulatory standards.
5. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource COMBIPATCH manufacturing to CMOs with specialized expertise in transdermal systems.
- Leading CMOs:
Organizations like Recipharm, Catalent, and Alcami are known for their capacity to scale production while maintaining stringent quality control.
Regulatory and Quality Considerations
Suppliers involved in COMBIPATCH production must comply with international standards such as FDA cGMP, EMA guidelines, and ISO certifications. Regulatory agencies often conduct regular audits to ensure that raw material quality, manufacturing processes, and documentation meet safety and efficacy benchmarks.
Emerging Trends and Challenges in Supply Chain
-
Supply Chain Resilience: Recent disruptions (e.g., COVID-19 pandemic) have prompted pharmaceutical companies to diversify supplier bases, especially for critical raw materials like APIs and adhesives.
-
Sustainability and Cost Optimization: Suppliers adopting eco-friendly practices and cost-effective production techniques are gaining preference, aligning with global sustainability goals.
-
Innovation in Materials: Advancements in biocompatible adhesives and permeation enhancers are expanding the scope of transdermal patches, influencing supplier development and partnerships.
Conclusion
The supply chain for COMBIPATCH spans diverse suppliers specializing in APIs, adhesives, backing materials, packaging, and contract manufacturing. Ensuring robustness and compliance across these segments is essential for delivering high-quality, safe, and effective transdermal patches. Strategic partnerships and supplier diversification are critical to mitigate risks and meet growing demand.
Key Takeaways
-
Diverse Supplier Base: COMBIPATCH manufacturing relies on a broad spectrum of specialized suppliers for APIs, adhesives, backing materials, and packaging.
-
Regulatory Compliance: Suppliers must meet rigorous GMP standards, crucial for maintaining product safety and regulatory approval.
-
Supply Chain Resilience: Diversification and agility in sourcing mitigate risks of disruptions, especially evident post-pandemic.
-
Innovation Drives Partnerships: Continuous advancements in materials science favor collaborations with suppliers leading in biocompatible and sustainable solutions.
-
Strategic Outsourcing: Contract manufacturing organizations are vital for scaling production while maintaining quality standards.
FAQs
1. Who are the primary API suppliers for COMBIPATCH?
Major multinational API manufacturers like Pfizer, Novartis, and niche suppliers such as CordenPharma supply high-quality APIs suited for transdermal systems, ensuring consistent drug delivery and regulatory compliance.
2. What are the critical qualities suppliers must possess for COMBIPATCH production?
Suppliers need to demonstrate GMP compliance, high purity standards, consistent batch-to-batch quality, and the ability to meet regulatory requirements for medical-grade materials.
3. How does supply chain diversification impact COMBIPATCH manufacturing?
Diversification reduces dependency on single sources, decreases risks of shortages, and enhances resilience against geopolitical, logistical, or pandemic-related disruptions.
4. Which emerging materials or technologies are influencing COMBIPATCH suppliers?
Innovations include ultra-thin, hypoallergenic adhesives, bio-based backing films, and permeation enhancers that increase drug absorption efficiency while maintaining skin safety.
5. What regulatory challenges do COMBIPATCH suppliers face?
Suppliers must navigate stringent approvals, maintain detailed documentation, and ensure ongoing compliance with evolving standards from agencies like FDA and EMA to sustain their roles in the supply chain.
References
[1] U.S. Food and Drug Administration. (2022). Good Manufacturing Practices (GMP) Guidelines.
[2] European Medicines Agency (EMA). (2022). Guidelines on Good Manufacturing Practices.
[3] MarketsandMarkets. (2023). Transdermal Drug Delivery Market by Region, Type, and Application.
[4] Smith, J. (2021). "Materials Innovation in Transdermal Patches," Pharmaceutical Technology.
[5] Contract Pharma. (2022). "Top CMOs in Transdermal Manufacturing."
More… ↓
