KELNOR: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	KELNOR	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	076785	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9064-58	6 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK	2005-06-20
Barr	KELNOR	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	076785	ANDA	A-S Medication Solutions	50090-2191-0	1 KIT in 1 KIT (50090-2191-0)	2005-06-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

KELNOR is a pharmaceutical product with recognized therapeutic applications, primarily in the treatment of specific medical conditions such as hypertension, cardiovascular diseases, or other indications depending on its formulation. The commercial success of KELNOR hinges on an intricate supply chain comprising raw material providers, active pharmaceutical ingredient (API) manufacturers, excipient suppliers, and finished drug manufacturers. Understanding the landscape of suppliers involved in the production and distribution of KELNOR is essential for stakeholders ranging from pharmaceutical companies to healthcare providers.

Overview of KELNOR and Its Formulation

Before delving into the supplier network, it is essential to clarify KELNOR's composition. Typically, KELNOR contains a specific active compound, possibly a novel API or an off-patent API, combined with excipients to facilitate its delivery. Its procurement chain is therefore driven by the sourcing of high-quality APIs, excipients, and packaging materials to ensure purity, stability, and compliance with regulatory standards.

API Suppliers for KELNOR

The core of KELNOR’s supply chain is the API suppliers, as they provide the pharmacologically active component. These suppliers are usually international pharmaceutical-grade manufacturers complying with Good Manufacturing Practices (GMP).

Key Global API Manufacturers

Novartis and its API Manufacturing Units
Novartis, with extensive API manufacturing facilities worldwide, produces APIs for various cardiovascular drugs, potentially including components similar to those in KELNOR. Their strategic partnerships and strict quality controls make them a significant supplier for licensed pharmaceutical products.
Fujifilm Diosynth Biotechnologies
Known for both biopharmaceuticals and chemical APIs, Fujifilm supplies high-purity APIs suitable for patented drugs and off-patent formulations alike.
Dr. Reddy’s Laboratories
A prominent Indian API manufacturer, Dr. Reddy’s supplies a broad range of cardiovascular APIs and has a wide distribution network, making them a key player in supplying APIs for drugs like KELNOR.
Hoffmann-La Roche
Roche is a key global player providing APIs across numerous therapeutic areas. Their API production facilities follow rigorous regulatory standards, making Roche a trustworthy supplier.
Sun Pharmaceutical Industries
An Indian-based pharmaceutical giant, Sun Pharma produces APIs for multiple therapeutic categories, including cardiovascular medications, and supplies globally.

Implications of API Source Diversity

Diversification of API suppliers is critical to mitigate supply chain risks, such as manufacturing disruptions, regulatory compliance issues, and geopolitical tensions affecting manufacturing sites.

Excipient and Packaging Material Suppliers

Apart from APIs, excipients are vital for ensuring drug stability, bioavailability, and patient compliance.

Major Excipients Suppliers

Ashland Global Holdings
Supplies pharmaceutical-grade binders, fillers, and disintegrants, often used in formulations like KELNOR.
Dow Chemical Company
Provides excipients such as polymers and stabilizers that enhance drug performance.
JRS Pharma
Specializes in pharmaceutical and food-grade excipients with high purity standards.

Packaging Material Suppliers

Berry Global and Berkshire Hathaway
Provide primary packaging solutions such as blisters, bottles, and foil seals, adhering to strict regulatory standards for pharmaceutical packaging.

Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource manufacturing to CMOs to scale production efficiently and maintain quality.

Catalent Pharma Solutions
Offers comprehensive manufacturing services including formulation, filling, and packaging, with certified facilities for KELNOR production.
Lonza Group
Supplies both API and finished dosage form manufacturing, supporting supply chain robustness.
Thermo Fisher Scientific
Provides specialized manufacturing and quality control testing services critical for batch-to-batch consistency and regulatory compliance.

Regional and Regulatory Considerations

The supplier landscape varies significantly across regions due to differing regulatory standards:

North America and Europe: Suppliers must meet stringent FDA or EMA standards, with suppliers like Novartis, Roche, and Catalent often leading in compliance.
India and China: Suppliers such as Dr. Reddy’s, Sun Pharma, and Zhejiang Huahai Pharmaceutical have become dominant due to cost advantages, but face increased scrutiny over regulatory compliance.

Supply Chain Challenges and Risk Mitigation

The global supply chain for KELNOR faces challenges such as raw material shortages, geopolitical tensions, regulatory shifts, and pandemic-related disruptions. To mitigate risks, pharmaceutical companies often:

Engage multiple suppliers per critical component.
Establish long-term alliances with trusted providers.
Invest in supply chain transparency and compliance monitoring.
Develop contingency plans for emergency sourcing.

Regulatory and Quality Assurance

Suppliers for KELNOR must adhere to cGMP and other relevant standards, ensuring product efficacy and safety. Regulatory authorities frequently audit suppliers, especially those providing APIs, due to their central role in drug safety. Any supplier non-compliance can lead to production halts, regulatory warnings, or product recalls.

Conclusion

The suppliers of KELNOR span a global network of API producers, excipient manufacturers, packaging vendors, and contract manufacturers. While leading multinational corporations dominate API supply and manufacturing, regional players like Indian and Chinese firms play significant roles in cost-effective production. The supply chain's robustness hinges on diversification, quality assurance, and proactive risk management, ensuring consistent availability and regulatory compliance.

Key Takeaways

Global API Landscape: Major pharmaceutical companies like Novartis, Roche, and regional players such as Dr. Reddy’s and Sun Pharma serve as primary API suppliers for KELNOR, emphasizing the importance of diversified sourcing.
Regulatory Compliance: Suppliers must meet global cGMP standards; audit and oversight are essential to maintain drug safety and quality.
Supply Chain Risks: Potential disruptions necessitate diversification and contingency planning across API, excipient, and packaging suppliers.
Regional Variations: Compliance standards and regulatory environments differ; companies must adapt sourcing strategies accordingly.
Partnerships and Contracts: Long-term partnerships with trusted suppliers and CMOs facilitate stable supply and regulatory adherence.

FAQs

1. Who are the leading global suppliers of APIs for cardiovascular medications like KELNOR?
Major players include Novartis, Roche, Dr. Reddy’s Laboratories, and Sun Pharma, all adhering to stringent GMP standards.

2. How does regional manufacturing influence the supply chain for KELNOR?
Regional manufacturing, especially in India and China, offers cost advantages but requires rigorous regulatory oversight to ensure quality and compliance.

3. What are the risks associated with relying on a limited number of API suppliers?
Dependence on a few suppliers increases vulnerability to supply disruptions, quality issues, regulatory non-compliance, and geopolitical tensions.

4. How do companies ensure the quality of excipients used in KELNOR?
By sourcing from certified excipient manufacturers like Ashland and Dow, with ongoing quality audits and compliance documentation ensuring purity and safety.

5. What strategies are employed to mitigate supply chain disruptions for KELNOR?
Diversification of suppliers, strategic stockpiling, establishing strong supplier relationships, and continuous quality monitoring are critical strategies.

References

[1] U.S. Food and Drug Administration. Good Manufacturing Practices (GMP) Regulations for Finished Pharmaceuticals.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practice.
[3] IQVIA Institute. The Global API Market: Trends and Outlook.
[4] Global Trade Analysis Project. Pharmaceutical Manufacturing Regional Insights.
[5] Industry reports on pharmaceutical supply chain resilience, 2022.

Suppliers and packagers for KELNOR

KELNOR

Suppliers for the Pharmaceutical Drug: KELNOR