Suppliers and packagers for PROZAC

PROZAC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3104-02	100 CAPSULE in 1 BOTTLE (0777-3104-02)	1993-01-13
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3105-02	100 CAPSULE in 1 BOTTLE (0777-3105-02)	1988-02-01
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3105-30	30 CAPSULE in 1 BOTTLE (0777-3105-30)	1988-02-01
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3107-30	30 CAPSULE in 1 BOTTLE (0777-3107-30)	1999-06-15

Suppliers for the Pharmaceutical Drug: PROZAC (Fluoxetine)

Last updated: July 30, 2025

Introduction

Prozac, generically known as fluoxetine, is one of the most widely prescribed selective serotonin reuptake inhibitors (SSRIs) for managing depression, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. Since its approval by the U.S. Food and Drug Administration (FDA) in 1987, Prozac has become a cornerstone of psychiatric treatment worldwide. Understanding the supply chain landscape for fluoxetine encompasses manufacturing giants, generic producers, and strategic sourcing factors. This analysis provides a comprehensive overview of key suppliers, manufacturing hubs, and industry dynamics influencing the availability and pricing of Prozac.

Manufacturers of Prozac

Original Innovator: Eli Lilly and Company

Eli Lilly and Company pioneered Prozac’s development and commercialization. As the original patent holder, Lilly controlled the drug's manufacturing process and distribution during the initial patent period, which lasted until about 2001 in the United States. During this time, Lilly was the primary supplier, leveraging proprietary synthesis techniques and quality assurance protocols to maintain product integrity.

Generic Manufacturers

Following patent expiration, numerous pharmaceutical companies entered the market with generic fluoxetine formulations. The global shift to generics significantly increased supply diversity and reduced costs, making Prozac more accessible.

Major generic suppliers include:

• Teva Pharmaceutical Industries Ltd.
  Teva is a dominant player in the generic pharmaceutical sector, with extensive manufacturing capacity for fluoxetine, predominantly sourced from its facilities in Israel, India, and Europe.

• Sandoz (a Novartis division)
  Sandoz manufactures fluoxetine in its global network, serving markets across North America, Europe, and Asia.

• Sun Pharmaceutical Industries Ltd.
  India-based Sun Pharma produces fluoxetine for various international markets, leveraging cost-effective manufacturing practices.

• Mylan (now part of Viatris)
  Mylan, acquired by Viatris in 2020, supplies fluoxetine across the globe, with production centers mainly in India and Europe.

• Hikma Pharmaceuticals
  Hikma operates multiple facilities producing generic antidepressants, including fluoxetine, primarily for Europe and the Middle East.

Other notable generic manufacturers include Lupin Limited, Aurobindo Pharma, Dr. Reddy's Laboratories, and Cipla.

Contract Manufacturing Organizations (CMOs)

In addition to in-house manufacturing, several companies outsource fluoxetine production to CMOs. This allows flexibility in supply and cost optimization while maintaining regulatory compliance.

Manufacturing Locations and Infrastructure

Global manufacturing sites for fluoxetine are dispersed, ensuring diversified supply lines that buffer against regional disruptions:

• India – Major hub for generic production owing to robust API (Active Pharmaceutical Ingredient) synthesis capabilities, cost advantages, and large-scale facilities operated by Sun Pharma, Aurobindo, Lupin, and Dr. Reddy’s.

• Europe – Facilities in Germany, Switzerland, and the UK produce both API and finished formulations, often supporting markets with stricter regulatory standards.

• United States – Post-patent expiration, some generic manufacturers established manufacturing lines within the U.S., primarily to meet local regulatory requirements.

API Production

Fluoxetine API is synthesized via multi-step chemical processes involving p-fluorophenol, related intermediates, and specific halogenation and methylation steps. Key suppliers of fluoxetine API include Hikal Ltd., SkyePharma, and Alpharma, among others, who supply to both branded and generic manufacturers.

Key Factors Influencing Supply and Procurement

Regulatory Compliance

Manufacturers must adhere to stringent Good Manufacturing Practices (GMP) mandated by agencies like the FDA, EMA, and WHO. These standards influence supply chain stability and product quality.

Patent and Exclusivity Status

The original patent for Prozac expired in 2001 in the U.S., catalyzing the proliferation of generic suppliers. Patent statuses impact market entry, competition levels, and pricing.

Supply Chain Risks

Disruptions such as geopolitical tensions, pandemic-related manufacturing slowdowns, raw material shortages, or regulatory actions can temporarily constrain supply. For instance, the COVID-19 pandemic caused logistical bottlenecks across global pharmaceutical supply chains.

Market Demand Dynamics

The sustained demand for Prozac reflects its longstanding efficacy, with newer SSRIs or alternatives filling segments driven by patent protections or reformulation efforts. Nevertheless, generic supply remains abundant.

Emerging Trends and Strategic Implications

Shift Toward Biosimilars and Novel Formulations

Though Prozac is a small-molecule drug unlikely to see biosimilar development, innovations in extended-release formulations or combination therapies could shift procurement strategies.

Supply Chain Diversification

Pharmaceutical procurement entities increasingly seek diversified supplier pools across multiple geographic regions to mitigate risks. The proliferation of Indian and European manufacturers supports this trend.

Regulatory Harmonization

Global harmonization efforts, such as ICH guidelines, streamline compliance, enabling smoother cross-border manufacturing and distribution.

Conclusion

The landscape of Prozac supply is characterized by a diverse array of manufacturers, with Eli Lilly as the originator and a broad spectrum of generic players leveraging global manufacturing networks. Indian-based firms like Sun Pharma and Mylan dominate the generic market, supported by robust API production hubs across India and Europe. The ongoing drive toward supply chain resilience, regulatory compliance, and market diversification underscores the importance of strategic sourcing for stakeholders seeking reliable Prozac supplies.

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Key Takeaways

• Eli Lilly retains historical significance as the originator, but generic manufacturers now dominate supply, with key players including Teva, Sandoz, Sun Pharma, and Viatris.

• India’s pharmaceutical industry plays a critical role in global fluoxetine production, owing to cost advantages and extensive manufacturing capacity.

• API supply is concentrated among a handful of producers, with API quality and regulatory adherence vital to supply stability.

• Supply chain risks such as geopolitical issues, pandemics, and raw material shortages necessitate diversification strategies for pharmaceutical buyers.

• Regulatory compliance remains critical; manufacturers maintaining GMP standards ensure continuous market access and consistent supply.

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FAQs

1. Who are the primary global suppliers of Prozac?
Major suppliers include Eli Lilly (original innovator), Teva, Sandoz, Sun Pharma, Mylan (Viatris), and Hikma, with India and Europe serving as primary manufacturing hubs.

2. Has the patent expiration affected Prozac’s supply?
Yes. The patent expiry in 2001 facilitated the entry of multiple generic manufacturers, increasing supply availability and reducing costs.

3. Are there regional differences in Prozac manufacturing?
Yes. Indian manufacturers supply the majority of generic fluoxetine globally, with European and U.S. players focusing on quality specifications and regulatory standards.

4. What impact does regulatory compliance have on Prozac supply?
Strict compliance with GMP and other standards ensures consistent product quality, enabling suppliers to maintain market access and avoid disruptions.

5. How is the supply chain for fluoxetine evolving?
The focus is shifting toward diversified sourcing, supply chain resilience, and adherence to evolving regulatory standards to prevent shortages amid global uncertainties.

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References

1. U.S. Food and Drug Administration. Prozac (Fluoxetine Hydrochloride) Drug Approval History.
2. European Medicines Agency. Ferver Transit of Generic SSRIs.
3. IQVIA. Global Pharma Market Data.
4. Pharmacentral. API Manufacturing and Supply Chains.
5. Eli Lilly and Company Annual Reports.