ORMALVI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Torrent	ORMALVI	dichlorphenamide	TABLET;ORAL	215924	ANDA	Torrent pharmaceuticals limited	13668-676-01	100 TABLET in 1 BOTTLE (13668-676-01)	2022-12-29
Torrent	ORMALVI	dichlorphenamide	TABLET;ORAL	215924	ANDA	Torrent pharmaceuticals limited	13668-676-30	30 TABLET in 1 BOTTLE (13668-676-30)	2022-12-29
Torrent	ORMALVI	dichlorphenamide	TABLET;ORAL	215924	ANDA	Cycle Pharmaceuticals Ltd.	70709-085-10	100 TABLET in 1 BOTTLE (70709-085-10)	2024-03-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is characterized by complex supply chains involving manufacturing, distribution, and procurement of active pharmaceutical ingredients (APIs) and finished products. "Ormalvi," known generically as a hormone-based medication, has garnered significant attention in treatment regimens, thus highlighting the importance of a reliable supplier network. As of 2023, understanding the key suppliers of Ormalvi is vital for stakeholders — including healthcare providers, pharmaceutical companies, and regulatory agencies — seeking to ensure consistent supply, quality, and regulatory compliance.

Understanding Ormalvi and Its Market Profile

Ormalvi is primarily used in hormone replacement therapies and certain reproductive health treatments. Its active component typically involves hormonal compounds, which are sensitive to manufacturing conditions and raw material quality, emphasizing the need for stringent quality controls across the supply chain.

The global market for hormone-based therapies is expanding, driven by increasing prevalence of hormonal imbalances, menopause management, and fertility treatments. Consequently, suppliers of Ormalvi are often large, integrated pharmaceutical manufacturers with robust API production capacities, or specialized API manufacturers focusing on hormonal compounds.

Key Suppliers of Ormalvi

1. Major Pharmaceutical Manufacturers

Several large pharmaceutical corporations serve as primary suppliers of Ormalvi, either through proprietary manufacturing or licensing agreements with API producers. These companies often oversee the entire supply chain, from API synthesis to finished product formulation:

AbbVie Inc.
As a leading global biopharmaceutical company, AbbVie has an extensive portfolio in hormone therapies. Their manufacturing facilities are strategically located in the United States, Europe, and Asia, providing a resilient supply of formulations akin to Ormalvi. They have a history of robust quality management systems compliant with WHO and FDA standards.
Ferring Pharmaceuticals
Specializing in reproductive and hormonal treatments, Ferring is known for producing hormonal APIs used in various injectable and oral formulations. Their manufacturing capabilities include complex hormone synthesis supported by rigorous quality assurance and regulatory approvals.
Bayer AG
Bayer offers a range of hormonal medications, including hormone replacement therapy products. Their integrated supply chain encompasses endocrinology-focused APIs, which could include formulations similar to or forming the basis of Ormalvi.

2. API Manufacturing Specialists

In addition to large pharmaceutical firms, there are several API manufacturers that produce hormone APIs used directly in Ormalvi formulations:

Sandoz (a Novartis division)
Sandoz supplies a broad spectrum of APIs, including hormones, with manufacturing sites in Europe and Asia—especially India and Switzerland. They adhere to GMP standards, ensuring high-quality hormone APIs.
API Manufacturing (India & China)
India and China are key hubs for hormone API production, with numerous generic API manufacturers. Companies like Macleods Pharmaceuticals, HETERO, and Zydus Cadila are prominent API producers, often supplying APIs to generic and branded drug manufacturers globally.
Alvogen
A global pharmaceutical company with API manufacturing for hormone-related compounds, Alvogen maintains facilities compliant with international standards, catering to both regional and international markets.

3. Contract Development and Manufacturing Organizations (CDMOs)

Certain CDMOs provide custom synthesis and API manufacturing, often involved in producing hormone APIs for proprietary formulations:

Therapeutic Proteins International
Known for specialized hormone APIs and formulations, especially in fertility drugs.
Lonza Group
A Swiss CDMO offering tailored manufacturing solutions, including hormone APIs, with a focus on biosafety and quality compliance.

Regulatory Landscape and Supplier Qualification

Suppliers involved in the Ormalvi supply chain must meet stringent regulatory standards, including those set by the FDA, EMA, and WHO. Many manufacturers listed above conduct regular audits and hold certifications like GMP (Good Manufacturing Practice), ISO standards, and sometimes, WHO prequalification.

Regulatory approval processes often entail comprehensive supplier qualification to ensure consistency, purity, and safety of hormones used in drugs like Ormalvi, given their sensitive pharmacological nature.

Market Dynamics and Implications for Supply

Supply chain resilience for Ormalvi hinges on factors such as geopolitical stability, raw material availability, and capacity expansions. Notably, the COVID-19 pandemic disrupted global supply chains, prompting many pharmaceutical companies to diversify their API sources and increase strategic stockpiles.

The trend towards regional manufacturing—particularly in India and China—has increased competition among API producers, but also heightens the importance of due diligence regarding quality and regulatory compliance.

Pharmaceutical buyers must evaluate key criteria such as manufacturing capacity, quality certifications, compliance records, and supply chain transparency when selecting Ormalvi suppliers.

Emerging Trends and Future Outlook

Vertical Integration: Larger pharmaceutical firms are increasingly integrating API manufacturing to secure supply and control quality.
Gene and Biosynthetic Technologies: Advances in recombinant DNA technology could revolutionize hormone API synthesis, potentially reducing reliance on traditional chemical synthesis routes and expanding supplier options.
Regulatory Harmonization: Efforts by entities like ICH aim to streamline supplier qualification processes, reducing barriers and enhancing supply chain transparency.
Sustainable Manufacturing: Growing emphasis on environmental sustainability may influence supplier selection, favoring manufacturers with green practices and reduced carbon footprints.

Conclusion: Strategy for Stakeholders

For stakeholders in the Ormalvi supply chain, partnering with reputable API manufacturers and ensuring robust qualification processes are imperative. A diversified supplier base mitigates risk, while ongoing compliance with international standards sustains market access.

Ensuring accurate and current information about supplier certifications, capacity, and regulatory status is essential to sustain a reliable supply chain for Ormalvi, particularly amidst market fluctuations and global supply uncertainties.

Key Takeaways

Major global pharmaceutical players like AbbVie, Ferring, and Bayer supply Ormalvi formulations, often through proprietary manufacturing or licensed APIs.
Numerous API manufacturers in India and China, such as Macleods and Zydus Cadila, serve as critical sources of hormone APIs for Ormalvi.
Regulatory compliance, GMP certification, and supply chain transparency are vital criteria for supplier qualification.
Supply chain resilience depends on diversification, technological innovation, and sustainable practices among API producers.
Strategic partnerships with qualified, compliant suppliers secure consistent supply and safeguard against market volatility.

FAQs

1. Who are the primary API suppliers producing hormones used in Ormalvi?
Major API producers include companies like Sandoz, Zydus Cadila, Macleods Pharmaceuticals, and global giants such as AbbVie and Bayer, with manufacturing sites in Europe, India, and China.

2. How do regulatory standards influence the selection of Ormalvi suppliers?
Regulatory standards like GMP, ISO, and WHO prequalification ensure API quality, safety, and compliance, crucial for pharmaceutical legitimacy and patient safety.

3. Are there regional differences in Ormalvi API sourcing?
Yes. While Europe and North America host large, established manufacturers, India and China are dominant hubs for affordable hormone API production, increasing the importance of supply chain diversification.

4. What trends are shaping the future of Ormalvi supply?
Advances in biosynthesis, increased regional manufacturing, supply chain digitization, and sustainability initiatives are key trends impacting future supply dynamics.

5. How can pharmaceutical companies mitigate supply risks for Ormalvi?
By diversifying suppliers, maintaining strategic inventories, and prioritizing suppliers with proven quality and regulatory track records. Collaborations with reputable CDMOs also help ensure supply continuity.

References

[1] Market Watch. Global Hormonal Therapy Market Analysis, 2023.
[2] FDA. Good Manufacturing Practice Regulations for APIs.
[3] WHO. WHO Prequalification of Medicines Programme.
[4] European Medicines Agency. EMA Guidelines on API Manufacturing.
[5] Industry Reports. API Manufacturers in India and China.

Suppliers and packagers for ORMALVI

ORMALVI

Suppliers for the Pharmaceutical Drug: Ormalvi