ATOMOXETINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983	ANDA	A-S Medication Solutions	50090-4236-0	30 CAPSULE in 1 BOTTLE (50090-4236-0)	2018-05-21
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983	ANDA	AvPAK	50268-057-13	30 BLISTER PACK in 1 BOX (50268-057-13) / 1 CAPSULE in 1 BLISTER PACK (50268-057-11)	2020-02-13
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983	ANDA	AvPAK	50268-058-13	30 BLISTER PACK in 1 BOX (50268-058-13) / 1 CAPSULE in 1 BLISTER PACK (50268-058-11)	2020-02-13
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983	ANDA	Golden State Medical Supply, Inc.	51407-100-30	30 CAPSULE in 1 BOTTLE (51407-100-30)	2017-05-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Atomoxetine hydrochloride, marketed primarily under the brand name Strattera, is a selective norepinephrine reuptake inhibitor used predominantly in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Its unique mechanism makes it a crucial therapeutic agent, with a significant global demand. The drug’s manufacturing and supply chain involve numerous pharmaceutical suppliers specializing in active pharmaceutical ingredients (APIs), excipients, and finished formulations.

This analysis explores the key suppliers for atomoxetine hydrochloride, considering their global footprint, manufacturing capabilities, quality standards, and regulatory compliance. Understanding these suppliers is vital for pharmaceutical companies, generic manufacturers, and healthcare stakeholders to ensure procurement stability, quality assurance, and competitive pricing.

Global Manufacturing Landscape of Atomoxetine Hydrochloride

The supply chain for atomoxetine hydrochloride is primarily divided among API producers, excipient suppliers, and finished drug manufacturers. Amid increasing demand, the pharmaceutical industry has seen both legacy players and emerging manufacturers entering the market.

Key API Suppliers for Atomoxetine Hydrochloride

1. Suzhou Dadao Pharmaceutical Co., Ltd.

Based in China, Suzhou Dadao is among the prominent API manufacturers of atomoxetine hydrochloride. They possess advanced synthesis capabilities compliant with Good Manufacturing Practices (GMP), catering predominantly to the Asian and global markets.

Manufacturing Capacity: Large-scale production facilities capable of supplying bulk API quantities.
Quality Assurance: ISO certifications and adherence to international GMP standards.
Regulatory Compliance: Active in obtaining necessary approvals, including Drug Master Files (DMFs) in the U.S. and Europe.

2. Zhejiang Hisoar Pharmaceutical Co., Ltd

This Chinese manufacturer is recognized for producing high-purity APIs, including atomoxetine hydrochloride, with a focus on quality and cost-efficiency.

Certifications: GMP compliance, ISO 9001, and other relevant standards.
Market Focus: Serves both domestic and export markets, including regulatory submissions for U.S. FDA and European authorities.

3. Cipla Ltd. (India)

Cipla, a global pharmaceutical giant, supplies atomoxetine hydrochloride API from its Indian manufacturing facilities.

Strengths: Extensive experience with ADHD medication APIs, robust quality controls.
Regulatory Profile: Compliant with both Indian and international standards, including FDA approvals.

4. Teva Pharmaceutical Industries Ltd. (Israel)

Teva has a diversified portfolio including APIs for ADHD medications and maintained a manufacturing footprint capable of supplying atomoxetine hydrochloride.

Capabilities: High-volume production with stringent quality and regulatory processes.
Global Reach: Distributes across North America, Europe, and emerging markets.

5. Dr. Reddy’s Laboratories (India)

Dr. Reddy’s supplies a range of neuropsychiatric API compounds, including atomoxetine hydrochloride, with a focus on affordability and quality.

Manufacturing Sites: Certified plants adhering to GMP standards.
Market Focus: Emphasizes exports to the U.S. and European markets.

Excipient and Formulation Suppliers

While the API is critical, excipients used in capsule and tablet formulations also form an integral supply chain component. Major excipient suppliers for such formulations include BASF, DuPont, and Ajinomoto. Their role ensures bioavailability and stability during shelf life.

Regulatory Considerations

Suppliers of atomoxetine hydrochloride are required to meet stringent quality standards mandated by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Securing approval involves detailed chemical, biological, and manufacturing process documentation.

A few top suppliers possess extensive regulatory dossiers, allowing their APIs to be used in licensed medicines worldwide. New entrants seeking market access often face a rigorous validation and inspection process.

Market Dynamics and Supplier Selection

Decisions around sourcing atomoxetine hydrochloride hinge on several considerations:

Quality assurance: Suppliers with GMP certification, validated quality controls, and robust compliance histories.
Cost-effectiveness: Asian manufacturers, notably Chinese and Indian entities, often offer competitive pricing due to lower manufacturing costs.
Regulatory maturity: Suppliers with existing DMFs and approval dossiers reduce time-to-market.
Capacity and scalability: Suppliers capable of scaling production to meet demand surges.

In recent years, geopolitical shifts and supply chain disruptions have increased interest in diversifying suppliers across regions. Many pharma companies have prioritized partnerships with multiple suppliers to ensure resilience.

Leading Finish-Formulation Manufacturers

Major pharmaceutical companies that assemble finished atomoxetine hydrochloride formulations include:

Shionogi & Co., Ltd. (Japan)
Eli Lilly and Company (U.S.)
Intas Pharmaceuticals (India)
Macleods Pharmaceuticals (India)

These companies often source APIs from multiple suppliers and have well-established quality assurance and distribution channels.

Emerging Suppliers and Market Trends

Emerging Chinese API manufacturers are investing in R&D and process improvements to meet international standards, providing high-quality atomoxetine hydrochloride at competitive prices. There is an increasing trend towards obtaining international certifications such as ISO and cGMP to access Western markets.

Similarly, the ongoing development of regional API hubs is reducing dependency on traditional suppliers in Europe and North America, with Asia dominating the market share.

Conclusion

The global supply chain for atomoxetine hydrochloride comprises a mixture of established international players and emerging regional manufacturers. China and India dominate the API production landscape, offering substantial capacity and cost advantages, while European and North American companies focus on high-quality, compliant production for specialized markets.

Ensuring supply resilience involves assessing suppliers’ regulatory standing, manufacturing capabilities, quality systems, and geopolitical stability. Strategic partnerships with multiple suppliers can mitigate supply chain risks, ensure consistent quality, and support market expansion.

Key Takeaways

Diverse Supplier Base: The primary API suppliers for atomoxetine hydrochloride include Chinese companies like Suzhou Dadao and Zhejiang Hisoar, as well as Indian companies such as Cipla, Dr. Reddy’s, and Teva.
Regulatory & Quality Standards: Suppliers with stringent GMP compliance and comprehensive regulatory dossiers are preferred to facilitate global distribution.
Cost and Capacity Considerations: Asian manufacturers provide competitive pricing and high-volume capacity, vital for meeting global demand.
Supply Chain Resilience: Diversification and strategic sourcing from multiple qualified suppliers minimize risks related to geopolitical factors or supply disruptions.
Market Trends: Increasing regulatory certifications and technological advancements in manufacturing are empowering emerging suppliers to participate more actively in global markets.

FAQs

Q1. Are Chinese API manufacturers for atomoxetine hydrochloride FDA-approved?
Many Chinese API producers operate under GMP standards and are working toward or have obtained necessary regulatory clearances, including DMFs submitted to the FDA. However, approval status varies by manufacturer, and due diligence is necessary before procurement.

Q2. How does supplier quality impact the final drug product?
High-quality API suppliers ensure drug consistency, efficacy, and safety. Poor quality APIs can lead to manufacturing failures, regulatory issues, and compromised patient outcomes.

Q3. Can I source atomoxetine hydrochloride from new or emerging suppliers?
Yes, but it is essential to verify their GMP compliance, quality certifications, and regulatory track record to mitigate risks of substandard materials.

Q4. What are regulatory hurdles for new API suppliers entering the global market?
New entrants need comprehensive dossiers demonstrating quality, safety, and efficacy, along with GMP certification, to obtain regulatory approvals like DMFs, which can be time-consuming.

Q5. How does geopolitical risk influence api sourcing for atomoxetine hydrochloride?
Geopolitical factors can impact supply continuity, import/export restrictions, and pricing. Diversifying suppliers across regions reduces geopolitical risks and supply chain vulnerabilities.

References:

[1] Relevant industry reports and data sources such as IQVIA, PhRMA, and industry-specific market analyses.
[2] Official regulatory agency publications, including the FDA and EMA databases.
[3] Company websites and financial disclosures of key API manufacturers.
[4] Scientific literature detailing synthesis processes and quality standards for atomoxetine hydrochloride.

Suppliers and packagers for generic pharmaceutical drug: ATOMOXETINE HYDROCHLORIDE