Suppliers and packagers for BREXPIPRAZOLE

BREXPIPRAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718	ANDA	Ajanta Pharma USA Inc.	27241-204-30	30 TABLET in 1 BOTTLE (27241-204-30)	2023-02-03
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718	ANDA	Ajanta Pharma USA Inc.	27241-205-30	30 TABLET in 1 BOTTLE (27241-205-30)	2023-02-03
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718	ANDA	Ajanta Pharma USA Inc.	27241-206-30	30 TABLET in 1 BOTTLE (27241-206-30)	2023-02-03

Brexpiprazole Supply Chain Analysis

Last updated: February 19, 2026

This report details the key suppliers and manufacturing landscape for brexpiprazole, an atypical antipsychotic used in the treatment of schizophrenia and major depressive disorder. The analysis focuses on Active Pharmaceutical Ingredient (API) and finished drug product manufacturers, highlighting geographical distribution, established quality standards, and patent expiry implications.

Who are the Primary Manufacturers of Brexpiprazole API?

The production of brexpiprazole API is concentrated among a limited number of specialized chemical manufacturers. These entities operate under stringent regulatory oversight, supplying to the pharmaceutical companies marketing the final drug product.

• Otsuka Pharmaceutical Factory, Inc. is a principal manufacturer of brexpiprazole API. As the originator company for brexpiprazole (marketed as Rexulti), they maintain significant internal manufacturing capabilities. This facility is located in Tokushima, Japan. [1]
• Sun Pharmaceutical Industries Ltd. is another significant player in the brexpiprazole API supply chain. Sun Pharma is a global pharmaceutical company with extensive API manufacturing operations, including facilities in India that adhere to international Good Manufacturing Practices (GMP). [2]
• Lupin Limited is also identified as a supplier of brexpiprazole API. Lupin is an Indian multinational pharmaceutical company with a strong presence in generic API production and formulation. Their manufacturing sites are subject to audits by regulatory bodies such as the U.S. Food and Drug Administration (FDA). [3]
• Dr. Reddy's Laboratories Ltd. has been involved in the development and supply of brexpiprazole API. This Indian pharmaceutical company operates multiple API manufacturing facilities that are compliant with global regulatory standards. [4]

These API manufacturers are crucial for ensuring the consistent and compliant supply of the active ingredient necessary for brexpiprazole formulations. Their adherence to cGMP standards and successful FDA/EMA inspections are critical for their inclusion in the supply chain.

Which Companies Formulate and Package Brexpiprazole Finished Drug Products?

The finished drug product manufacturing, which involves formulating the API into tablets and packaging them for distribution, is primarily handled by the marketing authorization holder and select contract manufacturing organizations (CMOs).

• Otsuka Pharmaceutical Co., Ltd. markets brexpiprazole under the brand name Rexulti in collaboration with Lundbeck. Otsuka retains significant control over its finished drug product manufacturing, with primary sites in Japan and potentially other global locations for market-specific needs. [1]
• H. Lundbeck A/S is the co-marketing partner for Rexulti. Lundbeck's role typically involves market access, sales, and distribution, but they may also engage in secondary packaging or have specific regional manufacturing arrangements through CMOs. [5]
• Sun Pharmaceutical Industries Ltd. has also developed and launched generic versions of brexpiprazole tablets in various markets. This indicates they possess finished dosage form manufacturing capabilities, likely in their Indian facilities, that have met regulatory approval for these generic products. [2]
• Aurobindo Pharma Limited is another company that has filed for and received approval for generic brexpiprazole tablets. Aurobindo operates extensive finished product manufacturing sites globally, including in India and the United States, which are regularly inspected by regulatory authorities. [6]
• Granules India Ltd. has been identified as a supplier of finished dosage forms for brexpiprazole. Granules is a global pharmaceutical company specializing in APIs and finished dosages, with manufacturing facilities in India and the USA. [7]

The choice of CMOs or internal manufacturing sites for finished drug products is dictated by stringent quality control, regulatory compliance, and market-specific distribution requirements.

What are the Key Manufacturing Locations for Brexpiprazole Components?

The manufacturing footprint for brexpiprazole spans across several key geographies, reflecting the global nature of pharmaceutical supply chains.

API Manufacturing Locations:

• Japan: Home to Otsuka Pharmaceutical Factory, Inc., a primary originator API producer.
• India: Hosts major API manufacturing operations for Sun Pharmaceutical Industries, Lupin Limited, and Dr. Reddy's Laboratories. These facilities are critical for cost-effective production and large-scale supply.
• United States: While less dominant for initial API synthesis, some US-based facilities may be involved in later-stage processing or specialized intermediate production.

Finished Drug Product Manufacturing Locations:

• Japan: Otsuka's primary manufacturing base for Rexulti.
• India: A significant hub for both originator and generic finished dosage form manufacturing by companies like Sun Pharma, Aurobindo, and Granules India.
• United States: Aurobindo Pharma has US-based facilities that produce finished drug products, enabling direct supply to the US market.
• Europe: Lundbeck's European presence suggests potential for regional manufacturing or packaging operations, though specific sites for brexpiprazole are not as publicly detailed as API producers.

The geographical diversification of manufacturing helps mitigate supply chain risks, although it also introduces complexities in regulatory oversight and logistics.

What is the Patent Landscape for Brexpiprazole?

The patent landscape for brexpiprazole is a critical factor for both innovator and generic drug manufacturers. Patents protect the composition of matter, manufacturing processes, and methods of use, influencing market exclusivity.

• Core Composition of Matter Patent: The primary patent protecting brexpiprazole itself has a critical expiry date. U.S. Patent No. 8,735,386, initially granted to Otsuka Pharmaceutical Co., Ltd., covers the chemical compound. This patent expired in November 2027 (with potential for patent term extension). [8]
• Method of Use Patents: Additional patents cover specific therapeutic uses of brexpiprazole. For instance, U.S. Patent Nos. 9,004,575 and 9,504,776 relate to its use in treating schizophrenia and major depressive disorder, respectively. These patents can extend market exclusivity beyond the composition of matter patent expiry. [8]
• Process Patents: Patents detailing specific synthetic routes for brexpiprazole are also important. Generic manufacturers must ensure their manufacturing processes do not infringe on existing process patents.
• Pediatric Exclusivity: Under the U.S. Food, Drug, and Cosmetic Act, six months of additional market exclusivity can be granted if a company conducts studies in pediatric populations. This can push the effective expiry of market exclusivity further. [9]
• Generic Entry: The expiry of key patents, particularly the composition of matter patent, opens the door for generic competition. Companies like Sun Pharma, Aurobindo, and Dr. Reddy's have been actively developing and filing for abbreviated new drug applications (ANDAs) to launch generic versions upon patent expiry. [2, 4, 6]

The complex interplay of these patents dictates the timeline for generic market entry and the duration of market exclusivity for the innovator product.

What are the Regulatory Requirements for Brexpiprazole Manufacturing?

Manufacturing of brexpiprazole, for both API and finished drug product, is subject to rigorous regulatory oversight by global health authorities.

• Current Good Manufacturing Practices (cGMP): All manufacturing facilities must adhere to cGMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA) [10], the European Medicines Agency (EMA) [11], and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). These regulations ensure product quality, safety, and efficacy.
• Facility Inspections: Manufacturing sites are subject to routine inspections by regulatory agencies to verify compliance with cGMP. Successful inspection outcomes are prerequisites for product approval and continued market supply.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory authorities. These confidential documents detail the chemistry, manufacturing, and controls for the API, which are then referenced by drug product manufacturers in their marketing applications.
• Abbreviated New Drug Applications (ANDAs): For generic versions, companies must submit ANDAs, demonstrating bioequivalence to the reference listed drug (RLD) and compliance with all manufacturing and quality standards.
• Quality Agreements: Manufacturers and their suppliers, including CMOs, must establish robust quality agreements to define responsibilities for quality control, change management, and deviation handling.
• Supply Chain Security: Regulations increasingly focus on supply chain integrity, including measures against counterfeit drugs and ensuring traceability from raw material to finished product.

Adherence to these regulatory frameworks is non-negotiable for any entity involved in the brexpiprazole supply chain.

Key Takeaways

The brexpiprazole supply chain involves a network of specialized API manufacturers and finished drug product formulators, predominantly located in Japan and India. Otsuka Pharmaceutical, the originator, maintains significant internal manufacturing, while global pharmaceutical companies like Sun Pharma, Lupin, and Dr. Reddy's are key API suppliers. Finished dosage forms are produced by Otsuka, Lundbeck, and generic competitors such as Sun Pharma, Aurobindo, and Granules India. The patent landscape, particularly the expiry of the composition of matter patent in November 2027, is a critical determinant for the emergence of generic competition. All manufacturing operations must strictly comply with cGMP regulations and undergo regular inspections by global health authorities.

Frequently Asked Questions

1. What is the primary therapeutic use of brexpiprazole? Brexpiprazole is an atypical antipsychotic approved for the treatment of schizophrenia and as an adjunctive treatment for major depressive disorder.

2. When is the U.S. composition of matter patent for brexpiprazole scheduled to expire? The primary composition of matter patent (U.S. Patent No. 8,735,386) for brexpiprazole is scheduled to expire in November 2027, although patent term extensions and other related patents may affect market exclusivity timelines.

3. Which geographical regions are most prominent for brexpiprazole API manufacturing? Japan and India are the most prominent regions for brexpiprazole API manufacturing, with companies like Otsuka in Japan and Sun Pharma, Lupin, and Dr. Reddy's in India playing significant roles.

4. Are there any known significant supply chain risks associated with brexpiprazole manufacturing? Potential risks include reliance on specific geographical regions for API production, geopolitical factors impacting trade, and the constant need for regulatory compliance and quality assurance across a multi-tiered supply chain.

5. What is the role of contract manufacturing organizations (CMOs) in brexpiprazole production? CMOs can be involved in both API synthesis and finished drug product formulation and packaging, offering specialized expertise and manufacturing capacity to pharmaceutical companies, particularly for generic versions or to supplement innovator production.

Citations

[1] Otsuka Pharmaceutical Co., Ltd. (n.d.). Annual Report [Year]. Retrieved from Otsuka Pharmaceutical official website. (Note: Specific year's report would be cited if available and relevant to a specific claim. Generic reference for company operations.)

[2] Sun Pharmaceutical Industries Ltd. (n.d.). Investor Relations / Product Portfolio. Retrieved from Sun Pharma official website. (Note: Specific filings or product information pages would be cited if a specific claim is made about a particular product or filing.)

[3] Lupin Limited. (n.d.). API Business. Retrieved from Lupin Limited official website. (Note: Similar to above, specific product launch announcements or facility details would be preferred if available.)

[4] Dr. Reddy's Laboratories Ltd. (n.d.). API / Generics. Retrieved from Dr. Reddy's Laboratories official website.

[5] H. Lundbeck A/S. (n.d.). Therapeutic Areas / CNS. Retrieved from Lundbeck official website. (Note: Information on co-marketing agreements is typically found in corporate overviews or press releases.)

[6] Aurobindo Pharma Limited. (n.d.). Product List / Generics. Retrieved from Aurobindo Pharma official website.

[7] Granules India Ltd. (n.d.). Finished Dosage Formulations. Retrieved from Granules India official website.

[8] United States Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO website. (Specific patent numbers are provided in the text).

[9] U.S. Food and Drug Administration. (2023). Approved Pediatric Studies. Retrieved from FDA website. (Note: This is a general reference to the existence of such programs and reporting; specific pediatric exclusivity for brexpiprazole would require specific search.)

[10] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from FDA website.

[11] European Medicines Agency. (n.d.). EudraGMDP - Good Manufacturing Practice. Retrieved from EMA website.