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GLATIRAMER ACETATE

ANDA

GLATIRAMER ACETATE | A214741 | SCINOPHARM TAIWAN LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: COPAXONE(TE code: AP)

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDGLATIRAMER ACETATE

DMF 258552012

AMBIO INCGLATIRAMER ACETATE

DMF 264892012

AMNEAL PHARMACEUTICALS LLCGLATIRAMER ACETATE

DMF 277232013

GLAND PHARMA LTDGLATIRAMER ACETATE

DMF 330922018

AURO PEPTIDES LTDGLATIRAMER ACETATE

DMF 354932020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 20MG/ML

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Dec 31, 2025

No patent or exclusivity listings for this strength.

#002 — 40MG/ML

0 patents0 exclusivities▾

INJECTABLE;SUBCUTANEOUS | Approved: Dec 31, 2025