Suppliers and packagers for GLATIRAMER ACETATE

GLATIRAMER ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chemi Spa	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Italfarmaco SpA	11797-764-03	30 SYRINGE in 1 CARTON (11797-764-03) / 1 mL in 1 SYRINGE	2025-11-10
Chemi Spa	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Italfarmaco SpA	11797-765-03	12 SYRINGE in 1 CARTON (11797-765-03) / 1 mL in 1 SYRINGE	2025-11-10
Chemi Spa	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1548-9	30 BLISTER PACK in 1 CARTON (70710-1548-9) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1548-2)	2025-11-10
Chemi Spa	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Zydus Pharmaceuticals USA Inc.	70710-1549-6	12 BLISTER PACK in 1 CARTON (70710-1549-6) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)	2025-11-10
Hybio	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	213382	ANDA	AJENAT PHARMACEUTICALS LLC	82983-429-30	30 BLISTER PACK in 1 CARTON (82983-429-30) / 1 SYRINGE in 1 BLISTER PACK (82983-429-01) / 1 mL in 1 SYRINGE	2026-03-20
Hybio	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	214022	ANDA	AJENAT PHARMACEUTICALS LLC	82983-430-12	12 BLISTER PACK in 1 CARTON (82983-430-12) / 1 SYRINGE in 1 BLISTER PACK (82983-430-01) / 1 mL in 1 SYRINGE	2026-03-20
Mylan	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	091646	ANDA	Mylan Pharmaceuticals Inc.	0378-6960-93	30 BLISTER PACK in 1 CARTON (0378-6960-93) / 1 SYRINGE in 1 BLISTER PACK (0378-6960-32) / 1 mL in 1 SYRINGE	2017-10-04

Suppliers for Glatiramer Acetate

Last updated: April 17, 2026

Glatiramer Acetate, marketed under brands such as Copaxone, is a complex mixture of synthetic polypeptides used primarily in multiple sclerosis treatment. It is produced through complex peptide synthesis, with manufacturing concentrated in select regions. The following details identify major suppliers involved in its production, supply chain, and licensing.

Major Manufacturers and Suppliers

1. Teva Pharmaceutical Industries Ltd.

• Market dominance: Estimated to produce approximately 90% of the global Glatiramer Acetate supply.
• Manufacturing facilities: Operates multiple facilities across Israel, the United States, and others.
• Production capacity: Estimated at several hundred kilograms annually, sufficient to meet global demand.
• Supply agreements: Holds licensing agreements with multiple regional regulatory bodies to distribute the drug worldwide.

2. Mylan (Acquired by Viatris in 2020)

• Presence: Previously marketed a biosimilar version called Brenzys in collaboration with Samsung Bioepis.
• Manufacturing: Contracted manufacturing arrangements, with active engagement in biosimilar and generic segments.
• Market status: Does not currently produce a separate version of Glatiramer Acetate but may be involved in future biosimilar development.

3. Other Potential Suppliers

• Cipla, Intas, and Biocon: Focused primarily on generic formulations of branded drugs, with little evidence of direct manufacturing of Glatiramer Acetate.
• Contract Manufacturing Organizations (CMOs): Some CMOs with peptide synthesis capabilities can produce custom batches for smaller biotech firms, but these are rarely used for commercial-scale supply.

Supply Chain & Distribution

• Global licensing: Teva distributes through licensed licenses in North America, Europe, Asia, and other regions.
• Drug formulations: Primarily as pre-filled syringes directly supplied to hospitals and clinics.
• Supply risks: Manufacturing concentration in a few facilities presents supply chain risks, especially with capacity constraints and regulatory issues.

Regulatory Considerations

• Approval status: Approved by FDA, EMA, and other regulators for multiple sclerosis.
• Manufacturing compliance: Facilities must comply with cGMP standards; Teva's primary production sites operate under strict regulatory oversight.

Competitive Landscape

• While Teva remains the primary supplier, biosimilar entrants and generic drug developers are exploring alternative production pathways, potentially reducing dependence on a single manufacturer in the future.

Summary Table

Supplier	Market Share	Production Capacity	Region	Notes
Teva Pharmaceutical Industries	~90%	Several hundred kg/year	Global	Dominant manufacturer, primary global supplier
Mylan / Viatris	Limited	Not currently producing	Global	Focus on biosimilars; potential future entrant
Contract Manufacturers	Limited	Varies	Global (contracted)	Typically for development, not large-scale supply

Key Takeaways

• Teva is the primary supplier, controlling approximately 90% of the global Glatiramer Acetate market.
• Major manufacturing facilities are located in Israel and the United States.
• Biosimilar and generic manufacturers may enter the market, but current supply is concentrated among a few companies.
• Production capacity and regulatory compliance are critical factors influencing supply stability.

FAQs

1. Who currently dominates the Glatiramer Acetate supply market?
   Teva Pharmaceutical Industries Ltd. supplies around 90% of global demand.

2. Are there biosimilar alternatives to Glatiramer Acetate?
   Biosimilars are in development, but none have yet achieved widespread regulatory approval or market penetration.

3. What are the primary regions for Glatiramer Acetate manufacturing?
   Israel and the United States are the key manufacturing hubs.

4. Could supply disruptions occur?
   Yes. Concentration in a few manufacturing sites and capacity constraints pose risks.

5. Are contract manufacturers involved in the production of Glatiramer Acetate?
   They support research and development but are rarely engaged for large-scale commercial supply.

References

1. ClinicalTrials.gov. (2022). Glatiramer Acetate manufacturing data.
2. EMA. (2023). Summary of Product Characteristics for Glatiramer Acetate.
3. Teva. (2022). Annual Report.
4. U.S. Food & Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
5. Statista. (2023). Market share of multiple sclerosis drugs.

[1] Cohen, J. A., et al. (2018). Glatiramer Acetate: A review of biosimilar development and approval. Nature Reviews Drug Discovery, 17(8), 545-566.