Viewing data from:

VINBLASTINE SULFATE

ANDA

VINBLASTINE SULFATE | A089395 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Response Letter from FDA CDER to Quad Pharmaceuticals FDA-1986-P-0057 Quad Pharmaceuticals, through Dr. Dilip P. Shah, filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting a determination that Vinblastine Sulfate Injection 1 mg/mL ready to use solution is suitable for submission as an Abbreviated New Drug Applicati	Suitability	2021-06-10	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs3 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MINAKEM HIGH POTENTVINBLASTINE SULFATE

DMF 53351984

HUBEI HONCH PHARMACEUTICAL CO LTDVINBLASTINE SULFATE PHARMACEUTICAL INTERMEDATE

DMF 392642024

HUBEI HONCH PHARMACEUTICAL CO LTDVINBLASTINE SULFATE NON-STERILE, BULK DRUG SUBSTANCE

DMF 399442025

CIPLA LTDInactiveVINBLASTINE SULFATE USP

DMF 64991986

ADITHYA ALKALOIDS LTDInactiveVINBLASTINE SULFATE

DMF 112841995

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveVINBLASTINE SULFATE USP

DMF 162402002

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

Products (1)

#001 — 10MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 9, 1987

No patent or exclusivity listings for this strength.