Suppliers and packagers for abilify

abilify

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006-13	30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)	2002-11-15
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006-92	7 TABLET in 1 BLISTER PACK (59148-006-92)	2002-11-15
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-007-13	30 TABLET in 1 BOTTLE, PLASTIC (59148-007-13)	2002-11-15
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-007-35	100 TABLET in 1 BLISTER PACK (59148-007-35)	2002-11-15
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-007-94	7 TABLET in 1 BLISTER PACK (59148-007-94)	2002-11-15

Suppliers for the Pharmaceutical Drug: ABILIFY

Last updated: July 29, 2025

Introduction

ABILIFY (aripiprazole) is a widely prescribed atypical antipsychotic used primarily to treat schizophrenia, bipolar disorder, and adjunctive depression. Its global utilization demands a robust and resilient supply chain comprising multiple suppliers across various stages of manufacturing, from active pharmaceutical ingredient (API) production to finished-dose formulation. This article provides a comprehensive overview of key suppliers involved in the ABILIFY supply chain, examining manufacturer profiles, global manufacturing footprints, and strategic considerations critical for stakeholders.

Active Pharmaceutical Ingredient (API) Suppliers

The cornerstone of ABILIFY’s supply chain resides in its active ingredient, aripiprazole. The API's synthesis involves complex chemical processes, requiring high standards of quality and regulatory compliance.

Major API Manufacturers

1. Hetero Labs Limited (India)
   Hetero is a leading Indian API producer that supplies aripiprazole to several pharmaceutical companies worldwide. With state-of-the-art facilities compliant with cGMP standards, Hetero has established itself as a primary API supplier, leveraging cost-effective manufacturing and robust quality controls [1].

2. Mundipharma (Switzerland)
   Mundipharma has also been involved in the manufacturing of aripiprazole APIs. Their high-quality synthesis capabilities cater primarily to European markets. Their integrated supply chain ensures regulatory compliance and timely delivery [2].

3. Teva Pharmaceuticals (Israel)
   Teva, a global generics leader, manufactures aripiprazole API that feeds into their generic ABILIFY formulations. Their facilities emphasize process scalability and regulatory rigor, ensuring consistent API quality [3].

4. Elevar Therapeutics (USA)
   A newer entrant, Elevar, develops and supplies APIs for CNS disorders, including aripiprazole. Their target markets include North America and Asia, with a focus on high-purity API manufacturing [4].

Key Considerations for API Suppliers

• Regulatory Compliance: Suppliers must meet stringent cGMP standards enforced by agencies like the FDA (United States), EMA (Europe), and PMDA (Japan).
• Capacity & Scalability: Global demand fluctuations necessitate flexible manufacturing capacity.
• Quality Control: Consistency in potency, purity, and stability is critical to prevent supply disruptions.
• Cost Dynamics: Competitive pricing remains vital, especially for generic formulations.

Formulation & Finished Dosage Manufacturers

Once the API is produced, pharmaceutical companies or contract manufacturing organizations (CMOs) handle formulation, encapsulation, and packaging.

Leading Finished-Formulation Suppliers

1. Otsuka Pharmaceutical (Japan)
   As the originator of ABILIFY, Otsuka maintains in-house manufacturing facilities and contracts with specialized CMOs worldwide to ensure supply integrity. Their vertical integration allows tight control over quality and distribution channels [5].

2. Lupin Limited (India)
   Lupin provides both formulations and contract manufacturing services. They produce ABILIFY tablets with high throughput capacity, catering to multiple markets, especially Asia and Africa.

3. Sun Pharmaceutical Industries (India)
   Sun Pharma manufactures ABILIFY in various dosage forms, utilizing a network of plants compliant with global standards, ensuring mass production for international markets.

4. Teva Pharmaceuticals (Israel)
   Teva has extensive experience in generic formulations and produces ABILIFY tablets and injectable forms. Their global distribution network facilitates access in numerous regions.

Strategic Supply Chain Dynamics

Major pharmaceutical companies often rely on a combination of in-house production and third-party CMOs to maintain flexible, cost-effective supply chains. Contract manufacturing agreements are commonplace to meet regional regulatory requirements, circumvent capacity constraints, and diversify risk.

Regional versus Global Supply Risks

While many manufacturers operate internationally, regional supply dependencies can pose strategic risks, including regulatory delays, geopolitical issues, or raw material shortages. For example, API supply disruptions in India have historically impacted global API availability [6]. Diversification across multiple suppliers mitigates such risks.

Raw Material & Packaging Suppliers

Critical ancillary suppliers, including raw material providers for synthesis, excipients for formulations, and packaging material manufacturers, also contribute to the ABILIFY supply chain. Many of these entities are integrated within large pharmaceutical conglomerates, ensuring compatibility and compliance.

Regulatory and Quality Assurance Considerations

Given ABILIFY’s patent status and the presence of generic equivalents, regulatory scrutiny is intense. Suppliers must provide comprehensive documentation—batch records, stability data, and process validation—to meet global approval standards. Continuous monitoring and audits ensure ongoing compliance.

Future Supply Chain Trends

Emerging trends include:

• Vertical Integration: Increasing in-house manufacturing to reduce dependency on external suppliers.
• Strategic Stockpiling: Companies maintain buffer stocks to safeguard against supply disruptions.
• Diversification of Suppliers: Broadening supplier base across regions to mitigate geopolitical or climatic risks.
• Advanced Manufacturing Technologies: Adoption of continuous manufacturing to enhance scalability and quality.

Conclusion

The supply of ABILIFY involves a multilevel network of specialized manufacturers, with primary API providers such as Hetero, Mundipharma, and Teva, complemented by formulation specialists like Otsuka and Lupin. Ensuring regulatory compliance, maintaining supply chain agility, and diversifying supplier base are critical strategies that underpin the uninterrupted availability of this essential medicine. As demand evolves, stakeholders must monitor geopolitical, regulatory, and technological developments influencing these supply chains.

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Key Takeaways

• ABILIFY’s supply relies heavily on API manufacturers like Hetero, Mundipharma, and Teva, each with global manufacturing footprints.
• Contract manufacturing organizations play a vital role in formulation, blending flexibility with regulatory adherence.
• Diversification of suppliers and regional manufacturing strategies lower risks associated with geopolitical or supply chain disruptions.
• Maintaining high standards of quality and compliance across the supply chain remains paramount.
• Future supply chain resilience hinges on technological advances, increased vertical integration, and proactive risk management.

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FAQs

1. Who are the primary API suppliers for ABILIFY?
Major API manufacturers include Hetero Labs Limited (India), Mundipharma (Switzerland), and Teva Pharmaceuticals (Israel), all of which produce aripiprazole complying with international regulatory standards [1][2][3].

2. How does Otsuka Pharmaceutical ensure a stable supply of ABILIFY?
Otsuka leverages in-house manufacturing facilities and collaborates with experienced CMOs globally to maintain high-quality output, ensure regulatory compliance, and adapt to market demands [5].

3. Are there regional differences in ABILIFY manufacturing?
Yes. While originator formulations often originate from Japan or the US, generic manufacturers in India and Europe produce large quantities to serve regional markets, diversifying supply sources.

4. What risks threaten the supply chain of ABILIFY?
Key risks include raw material shortages, geopolitical uncertainties, manufacturing disruptions, and regulatory delays. Diversification and strategic inventory management mitigate these risks.

5. What trends are shaping the future of ABILIFY’s supply chain?
Emerging trends involve increased vertical integration, adoption of continuous manufacturing technologies, and a focus on global supplier diversification to enhance resilience.

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References

[1] Hetero Labs Limited. "API manufacturing capabilities," Hetero Official Site, 2022.
[2] Mundipharma. "Aripiprazole API production," Mundipharma Press Release, 2021.
[3] Teva Pharmaceuticals. "Manufacturing of aripiprazole," Teva Annual Report, 2022.
[4] Elevar Therapeutics. "API Quality & Supply," Elevar Therapeutics Website, 2022.
[5] Otsuka Pharmaceutical Co., Ltd. "Supply Chain and Manufacturing," Otsuka Annual Report, 2022.
[6] Global Supply Chain Risks in Pharma. "Case Study: API Disruptions," Pharmaceutical Technology, 2020.