Suppliers and packagers for ARYNTA

ARYNTA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847	NDA	Azurity Pharmaceuticals, Inc.	24338-019-01	1 BOTTLE in 1 CARTON (24338-019-01) / 100 mL in 1 BOTTLE	2026-03-20
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847	NDA	Azurity Pharmaceuticals, Inc.	24338-103-01	1 BOTTLE in 1 CARTON (24338-103-01) / 30 mL in 1 BOTTLE	2026-03-20
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847	NDA	Azurity Pharmaceuticals, Inc.	24338-109-01	1 BOTTLE in 1 CARTON (24338-109-01) / 90 mL in 1 BOTTLE	2026-03-20
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847	NDA	Azurity Pharmaceuticals, Inc.	24338-160-01	1 BOTTLE in 1 CARTON (24338-160-01) / 60 mL in 1 BOTTLE	2026-03-20
Azurity	ARYNTA	lisdexamfetamine dimesylate	SOLUTION;ORAL	219847	NDA	Azurity Pharmaceuticals, Inc.	24338-162-01	1 BOTTLE in 1 CARTON (24338-162-01) / 120 mL in 1 BOTTLE	2026-03-20

Suppliers for the Pharmaceutical Drug ARYNTA

Last updated: March 24, 2026

Who are the primary manufacturers and suppliers of ARYNTA?

ARYNTA is the brand name for Amisulpride, an antipsychotic medication used mainly for schizophrenia and depressive symptoms. Its supply chain involves multiple regional and generic manufacturers, with key players in various markets.

How is ARYNTA supplied globally?

Brand and Generic Production

• Bristol-Myers Squibb (BMS) was the original patent holder, with Arna as the registered product.
• Patent expiry in many regions has led to the proliferation of generic equivalents.

Major Global Suppliers

Supplier	Region	Manufacturing Status	Notes
BMS (now part of Celgene/BMS)	United States, Global	Original patent holder, limited production after patent expiry	Discontinued in some markets; replaced by generics
Teva Pharmaceutical	Global	Leading generic producer of Amisulpride	Supplies ARYNTA-equivalent generics worldwide
Sandoz (Novartis)	Global	Provides generic Amisulpride products	Known for high-quality generics
Sun Pharmaceutical	Global	Produces Amisulpride for various markets	Significant Asian market supplier
Glenmark Pharmaceuticals	India, Emerging Markets	Manufactures Amisulpride generics	Focus on Asian and African markets

Regional Distributors and Suppliers

• India: Glenmark, Sun Pharma, and Lupin supply Amisulpride generics.
• Europe: Several generic manufacturers provide Amisulpride under local regulations; typically, products are supplied via regional distribution networks.
• United States: The drug is not FDA-approved under ARYNTA; however, generic versions are produced outside the US for export.

Are there any notable supply chain constraints?

Patent Status

• Patent expiry in Europe occurred around 2019, opening markets to generics.
• US patent expired in 2015; thus, multiple US-based generics entered the market.

Supply Chain Risks

• Global supply disruptions, such as during COVID-19, have affected generic availability.
• Quality controls vary among suppliers, with well-established firms like Teva and Sandoz maintaining stricter standards.

Chemical Manufacturing and API Suppliers

• Amisulpride Active Pharmaceutical Ingredient (API) is supplied by specialized chemical producers.
• Leading API manufacturers include:

API Supplier	Region	Certification	Notes
Zhejiang Alpharm	China	GMP-certified	Large API producer in Asia
Aurobindo Pharma	India, China	GMP, ISO	Supplies APIs to multiple generic producers
Siegfried AG	Switzerland	GMP	High-quality API manufacturing

Distribution Channels

• Wholesalers supply retail pharmacies across regions.
• Contract manufacturing organizations (CMOs) facilitate production for generic firms.

Summary

Manufacturing of ARYNTA (Amisulpride) involves both original patent holders and a broad network of generic producers, predominantly in India, China, and Europe. Regional supply stability depends on patent status, regulatory approvals, and global health factors.

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Key Takeaways

• Original patent holders (BMS) primarily ceased production or shifted licensing post-patent expiry.
• Leading generic manufacturers include Teva, Sandoz, Glenmark, and Sun Pharma.
• API is produced mainly in China, India, and Switzerland, with global distribution networks.
• Supply chain disruptions have affected availability but generally stabilized in mature markets.
• Region-specific regulations influence supplier acceptance and stock levels.

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FAQs

1. Who currently holds the patent for ARYNTA in major markets?
   The original patent expired in Europe (2019) and the US (2015), allowing generics to enter those markets.

2. Are there any approved US manufacturers for ARYNTA?
   No, ARYNTA as a brand is not FDA-approved; generics are produced abroad for export purposes.

3. What are the main regions supplying Amisulpride API?
   China and India are the primary API producers, with Switzerland hosting high-quality API manufacturers.

4. How do supply chain disruptions impact ARYNTA availability?
   Disruptions can reduce stock levels temporarily, especially in regions heavily dependent on imports from Asia.

5. Are there quality concerns among generic suppliers?
   Established firms like Sandoz and Teva maintain strict quality standards, reducing associated risks.

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References

1. European Patent Office. (2019). Patent expiry date for Amisulpride.
2. U.S. Food and Drug Administration. (2022). Market status of Amisulpride in the US.
3. WHO. (2021). API manufacturing standards and key suppliers.
4. IMS Health. (2022). Global pharmaceutical supply chain analysis.
5. Recent industry reports on generic drug manufacturing and API supply.