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Last Updated: December 14, 2025

Suppliers and packagers for generic pharmaceutical drug: ESCITALOPRAM OXALATE


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ESCITALOPRAM OXALATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Almatica ESCITALOPRAM escitalopram oxalate CAPSULE;ORAL 219130 NDA Almatica Pharma LLC 52427-795-30 30 CAPSULE in 1 BOTTLE (52427-795-30) 2025-10-06
Amneal Pharms ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 202227 ANDA Amneal Pharmaceuticals LLC 65162-705-88 240 mL in 1 BOTTLE (65162-705-88) 2011-09-03
Aurobindo Pharma Ltd ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 079062 ANDA Rising Pharma Holdings, Inc. 16571-769-24 240 mL in 1 BOTTLE (16571-769-24) 2012-04-03
Aurobindo Pharma Ltd ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 079062 ANDA Aurobindo Pharma Limited 65862-248-24 240 mL in 1 BOTTLE (65862-248-24) 2012-04-03
Chartwell Molecular ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 090477 ANDA Chartwell RX, LLC 62135-729-24 2 TRAY in 1 BOX (62135-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-729-10) 2023-06-12
Chartwell Molecular ESCITALOPRAM OXALATE escitalopram oxalate SOLUTION;ORAL 090477 ANDA Chartwell RX, LLC 62135-729-37 240 mL in 1 BOTTLE (62135-729-37) 2023-06-12
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Escitalopram Oxalate

Last updated: July 27, 2025

Introduction

Escitalopram oxalate, a selective serotonin reuptake inhibitor (SSRI), is widely prescribed for depression and anxiety disorders. Its global demand has prompted a robust supply chain featuring numerous active pharmaceutical ingredient (API) manufacturers and finished drug producers. Understanding the landscape of suppliers—ranging from raw material providers to finished drug manufacturers—is critical for pharmaceutical companies, generic drug producers, and healthcare stakeholders aiming to ensure a reliable supply, competitive pricing, and regulatory compliance.

This report explores key suppliers for escitalopram oxalate, including API manufacturers, contract manufacturing organizations (CMOs), and finished pharmaceutical product (FPP) producers. Emphasis is placed on geographic distribution, capacity, regulatory standing, and market influence.


Global API Manufacturers of Escitalopram Oxalate

Major Indian Manufacturers

India remains the predominant hub for the production of escitalopram oxalate API, driven by lower manufacturing costs, established pharmaceutical infrastructure, and a robust export network.

  • Torrent Pharmaceuticals: As one of India’s leading pharmaceutical companies, Torrent offers high-quality APIs, including escitalopram oxalate, approved by stringent regulatory agencies like the USFDA, EMA, and WHO. Their manufacturing facilities adhere to GMP standards, and they have extensive global distribution channels.

  • Hetero Labs: Hetero is a key generic API producer recognized for its large-scale manufacturing capacity. Their facilities are compliant with international regulatory norms, enabling them to supply to North America, Europe, and emerging markets.

  • Dr. Reddy’s Laboratories: A global pharmaceutical player, Dr. Reddy’s manufactures escitalopram oxalate API for both their in-house formulations and third-party clients. They maintain high compliance standards with comprehensive regulatory approvals.

  • Aurobindo Pharma: A major player in the API market, Aurobindo produces escitalopram oxalate with a focus on quality standards suitable for the US and European markets.

Chinese Manufacturers

China's pharmaceutical industry has expanded its API production capacity significantly, including for psychiatric medications like escitalopram oxalate.

  • Bolan Pharmaceutical: Known for producing a variety of SSRIs, Bolan supplies high-purity escitalopram oxalate APIs largely to North American and European markets.

  • Zhejiang Tiangui Pharmaceutical: Recognized for robust manufacturing scales and API quality, Tiangui exports escitalopram oxalate to global markets, complying with international GMP standards.

European and North American Manufacturers

While less prominent than Indian and Chinese producers, certain European and US-based API manufacturers serve niche markets with highly regulated supply chains.

  • Molekula Ltd. (UK): Specializes in active pharmaceutical ingredients, including escitalopram oxalate, with an emphasis on quality and supply chain transparency.

  • Almac Group (Northern Ireland): Provides custom synthesis and scalable manufacturing for complex APIs, including escitalopram oxalate, catering to pharmaceutical innovators and generic firms.


Contract Manufacturing Organizations (CMOs) for Escitalopram Oxalate

CMOs play a pivotal role in scaling production, particularly for generic drug companies seeking expedited market entry.

  • Famar: A European CMO with capabilities in synthesis, formulation, and packaging, Famar offers contract manufacturing for escitalopram oxalate to large pharmaceutical firms.

  • ViCryo: Specializing in sterile and solid dosage forms, ViCryo collaborates with API suppliers for integrated manufacturing solutions, including escitalopram-based products.

  • Siegfried AG: With extensive experience in API supply and formulation, Siegfried partners with pharmaceutical companies in Europe and North America for escitalopram oxalate production.


Finished Pharmaceutical Product (FPP) Manufacturers

While many pharmaceutical companies produce branded and generic escitalopram oxalate tablets, several operate as key global suppliers, either through direct manufacturing or via licensed partnerships.

  • LUNDBECK (Denmark): Originally developed the original escitalopram formulation, now controls the brand Lexapro. Although they focus on branded products, they maintain a broad supply chain network.

  • Teva Pharmaceutical Industries: A leading generic manufacturer, Teva produces escitalopram oxalate formulations for various markets, leveraging both domestic and outsourced API sources.

  • Mylan (now part of Viatris): Mylan supplies generic escitalopram tablets globally, sourcing APIs from reliable international suppliers.

  • Sun Pharmaceutical Industries: Incorporates escitalopram formulations into their mental health portfolio, sourcing APIs globally to ensure cost competitiveness.


Supply Chain Dynamics and Regulatory Considerations

Ensuring a secure supply of escitalopram oxalate hinges on the interplay of reliable API manufacturing, regulatory compliance, and logistics capability. Many Indian and Chinese manufacturers have achieved approvals from agencies like the USFDA, EMA, or WHO, which are critical for market access in regulated markets.

However, geopolitical factors, trade policies, and quality standards influence global supplier reliability. Companies should prioritize suppliers with proven regulatory track records, GMP compliance, and contingency plans for supply disruptions.


Emerging Trends and Future Outlook

The global demand for escitalopram oxalate continues to grow, driven by increased awareness and acceptance of mental health treatments. The expansion of API manufacturing capacity in India and China aims to meet this demand, with ongoing investments in quality control and regulatory adherence.

Furthermore, partnerships between global pharmaceutical companies and local API producers are increasing, emphasizing quality assurance and supply chain transparency. The move toward sustainable manufacturing practices is also influencing procurement strategies, favoring suppliers committed to environmentally responsible operations.


Key Takeaways

  • India dominates the escitalopram oxalate API market, led by companies like Torrent, Hetero, Dr. Reddy's, and Aurobindo, all compliant with international standards.

  • Chinese manufacturers such as Bolan and Zhejiang Tiangui are significant players, expanding capacity and market reach.

  • European and North American suppliers, including Molekula and Almac, serve niche markets with specialized manufacturing capabilities.

  • Contract manufacturing organizations facilitate scalable production and expedite market entry for generic formulations.

  • Regulatory compliance, supply chain transparency, and geopolitical stability are critical considerations for procurement.

  • Growing global demand underscores the importance of diversified supplier portfolios to mitigate risks and ensure continuous supply.


FAQs

1. Who are the leading API manufacturers of escitalopram oxalate globally?
Indian companies such as Torrent, Hetero, Dr. Reddy’s, and Aurobindo are primary API producers, complemented by Chinese firms like Bolan Pharmaceutical and Zhejiang Tiangui. European providers like Molekula and Almac also play vital roles.

2. What qualities should companies consider when sourcing escitalopram oxalate API?
Regulatory approvals (e.g., USFDA, EMA), GMP compliance, manufacturing capacity, quality consistency, and supply chain reliability are paramount.

3. How do geopolitical factors influence the supply chain of escitalopram oxalate?
Trade restrictions, tariffs, and regional regulatory changes can impact sourcing from China and India, emphasizing the need for diversified and compliant suppliers.

4. Are there reputable contract manufacturers for escitalopram oxalate?
Yes, organizations like Famar, Siegfried AG, and ViCryo offer contract manufacturing services, providing scalable and regulatory-compliant production.

5. Is the supply risk of escitalopram oxalate increasing?
While overall supply remains stable due to multiple global suppliers, factors such as GMP issues, geopolitical tensions, and raw material shortages could introduce risks, making supplier diversification strategic.


Sources:

[1] Market research reports and industry databases.
[2] Company websites and official regulatory filings.
[3] U.S. Food and Drug Administration (FDA) database.
[4] European Medicines Agency (EMA) publications.
[5] Industry analysis articles and pharmaceutical trade publications.

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