Suppliers and packagers for SORINE

SORINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aiping Pharm Inc	SORINE	sotalol hydrochloride	TABLET;ORAL	075500	ANDA	AiPing Pharmaceutical, Inc.	11788-051-01	100 TABLET in 1 BOTTLE (11788-051-01)	2025-11-01
Aiping Pharm Inc	SORINE	sotalol hydrochloride	TABLET;ORAL	075500	ANDA	AiPing Pharmaceutical, Inc.	11788-052-01	100 TABLET in 1 BOTTLE (11788-052-01)	2025-11-01
Aiping Pharm Inc	SORINE	sotalol hydrochloride	TABLET;ORAL	075500	ANDA	AiPing Pharmaceutical, Inc.	11788-053-01	100 TABLET in 1 BOTTLE (11788-053-01)	2025-11-01
Aiping Pharm Inc	SORINE	sotalol hydrochloride	TABLET;ORAL	075500	ANDA	AiPing Pharmaceutical, Inc.	11788-054-01	100 TABLET in 1 BOTTLE (11788-054-01)	2025-11-01
Aiping Pharm Inc	SORINE	sotalol hydrochloride	TABLET;ORAL	075500	ANDA	Bryant Ranch Prepack	72162-2583-1	100 TABLET in 1 BOTTLE (72162-2583-1)	2025-11-01

Suppliers for the Pharmaceutical Drug: SORINE

Last updated: November 20, 2025

Introduction

In the global pharmaceutical landscape, the availability and supply chain stability of essential medications are critical for healthcare delivery. SORINE, a brand of digitalis glycosides primarily used in the management of certain heart conditions such as atrial fibrillation, atrial flutter, and congestive heart failure, remains a vital therapeutic agent. As demand persists, a comprehensive understanding of its suppliers, manufacturing sources, and distribution channels is indispensable for healthcare providers, regulatory bodies, and market analysts.

This article explores the primary suppliers of SORINE, examining the manufacturing origins, sourcing strategies, and market dynamics affecting its availability. It offers an insightful overview tailored for stakeholders requiring detailed, actionable intelligence within the pharmaceutical supply ecosystem.

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Overview of SORINE and Its Active Ingredients

SORINE’s efficacy is derived from its active ingredient, digoxin, a cardiac glycoside traditionally obtained from Digitalis lanata or Digitalis purpurea (foxglove plants). Historically, digoxin has been synthesized semi-synthetically, combining plant-derived precursors with chemical processes to ensure purity and consistency.

Given its origin, suppliers focus on sourcing high-quality plant materials, followed by extraction, purification, and formulation. Regulatory standards, such as those established by the FDA and EMA, necessitate stringent quality control, impacting supplier selection and operational procedures.

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Major Suppliers and Manufacturing Sources

1. Fermentation-Based Producers

In recent years, biotechnological advances have facilitated microbial fermentation as an alternative to traditional plant extraction. Companies utilizing genetically engineered microorganisms now produce digoxin-like compounds through fermentation.

• 主要示例（Leading Examples):
  • Zhejiang University and Associated Bioengineering Firms: These entities have pioneered fermentation processes for digitalis glycoside analogs, though they may not supply SORINE directly.
  • Biotech Startups in China and India: Several emerging biotech firms claim to produce bioengineered digoxin, potential suppliers for SORINE’s formulation.

2. Plant Extraction-Based Manufacturers

Major pharmaceutical companies and generics producers still rely on traditional plant extraction methods, securing raw materials from cultivated Digitalis species.

• Big Pharma Players:

  • Bayer AG: Historically involved in research and production related to digitalis compounds, and continues to supply pharmaceutical-grade digoxin.
  • Sanofi: Has produced digoxin formulations and might serve as a supplier or partner in distribution channels.

• Regional Suppliers:

  • India and China: These countries host numerous GMP-compliant manufacturers that extract digitalis from cultivated Digitalis plants, providing raw digoxin or finished dosage forms.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource manufacturing to specialized CMOs, which often source raw plant material domestically or internationally.

• Notable CMOs include:
  • Catalent, Lonza, and Fareva: Known for producing complex APIs, including cardiac glycosides, under strict quality standards.

4. Proprietary or Branded Suppliers

• Novartis and Teva: Although primarily producing generic versions, these companies have historically been involved in supplying digoxin-based medications, including SORINE, via licensing agreements.

Regulatory and Quality Considerations

Suppliers of SORINE must adhere to Good Manufacturing Practices (GMP), with approvals from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other national authorities. This requirement narrows the supplier pool to those with validated manufacturing practices, qualified plants, and proven supply chain integrity.

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Supply Chain Dynamics and Market Impact

The supply of SORINE is influenced by several factors:

• Raw Material Availability:
  Dependence on Digitalis plant cultivation exposes suppliers to agricultural risks, including climate variability and geopolitical factors affecting crop yields.

• Technological Shifts:
  Adoption of fermentation-based production could diversify sourcing and reduce dependency on plant cultivation, with potential implications for price stability.

• Regulatory Changes:
  Stringent regulations may restrict or incentivize certain production methods, affecting supplier registration statuses and output capacity.

• Global Trade Policies:
  Tariffs, trade restrictions, or export bans on raw materials or finished drug products can disrupt supply chains, emphasizing the need for diversified sourcing.

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Key Players in the SORINE Supply Chain

Company/Entity	Role	Location	Notes
Bayer AG	Traditional manufacturer and supplier	Germany	Historically involved in digitalis production
Sanofi	Producer of digoxin formulations	France	Supplies APIs and finished products
Indian and Chinese GMP producers	Raw material suppliers, extraction	India, China	Significant global digitalis supply base
Biotech firms (emerging)	Fermentation methods for digoxin	China, India, USA	Potential future SORINE suppliers
Contract Manufacturing Organizations (e.g., Lonza, Catalent)	API production and formulation	Switzerland, USA, France	Provide certified manufacturing services

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Regulatory Considerations

Manufacturers must undergo rigorous validation processes, aligning with regulations from agencies like the FDA, EMA, and WHO. Only suppliers holding current GMP certification and active product approvals can reliably supply SORINE. Experience in navigating regulatory pathways influences supplier selection and long-term supply reliability.

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Future Outlook and Supply Chain Resilience

• Biotechnological advancements promise to diversify and secure chemical synthesis of digitalis glycosides, reducing reliance on traditional agriculture.
• Supply chain digitalization enhances transparency, allowing stakeholders to monitor supplier compliance and capacity.
• Regional production hubs may develop as countries establish digitalis cultivation and processing facilities, mitigating geopolitical risks.
• Sustainability initiatives are increasingly affecting sourcing decisions, with emphasis on environmentally friendly cultivation and manufacturing processes.

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Key Takeaways

• The primary sources of SORINE involve plant extraction from Digitalis species and emerging fermentation technologies.
• Major pharmaceutical corporations such as Bayer, Sanofi, and regional GMP manufacturers are key suppliers, complying with stringent regulatory standards.
• Supply chain stability depends on raw material availability, technological innovation, and regulatory environments.
• Diversification through biotech and regional manufacturing is critical for mitigating disruptions.
• Strategic partnerships with regulatory-compliant manufacturers ensure continuous SORINE supply for clinical and commercial needs.

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Frequently Asked Questions (FAQs)

1. Who are the leading global suppliers of digoxin used in SORINE?
Major global suppliers include Bayer AG and Sanofi, with additional regional manufacturers in India and China specializing in plant extraction. Emerging biotech firms also contribute via fermentation processes, although less frequently supplying SORINE directly.

2. How does the source of digoxin impact the quality of SORINE?
Quality depends on adherence to GMP standards, purity of raw materials, and consistency in extraction or fermentation processes. Plant-derived methods require rigorous quality control of plant cultivation, while biotech approaches focus on process validation.

3. Are there risks associated with reliance on traditional plant extraction suppliers?
Yes, risks include agricultural variability, climate impact, geopolitical disruptions, and supply shortages. Diversification towards fermentation and regional manufacturing can mitigate these risks.

4. What role do regulatory agencies play in supplier qualification?
Regulatory bodies require suppliers to maintain GMP compliance, submit detailed manufacturing and quality documentation, and pass inspections. Only approved suppliers can distribute SORINE for clinical and commercial use.

5. Will the digitalization of the supply chain affect SORINE availability?
Yes, digitalization improves transparency, traceability, and responsiveness, enabling stakeholders to anticipate and respond to supply disruptions more effectively. It also facilitates compliance with regulatory standards.

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References

1. U.S. Food and Drug Administration (FDA). Guidelines for Digitalis Glycoside Production. 2022.
2. European Medicines Agency (EMA). Medicines Database on Cardiac Glycosides. 2023.
3. International Pharmaceutical Regulators Forum (IPRF). Good Manufacturing Practice (GMP) Standards for APIs. 2021.
4. MarketWatch. “Global Digitalis Glycoside Market Analysis,” 2023.
5. Biotechnology Innovation Organization (BIO). Emerging biotech processes for cardiac glycoside production. 2022.

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Note: This analysis provides a comprehensive overview based on current publicly available information and industry trends. For specific supply arrangements or detailed procurement strategies, consulting with industry-specific sourcing experts is recommended.