01 1Acetic Acid
02 1Ammonium Chloride
03 1Calcium Acid Phosphate
04 1Copper Carbonate
05 1Disodium Hydrogen Phosphate
06 1Edetate Calcium Disodium
07 1L-Tartaric Acid
08 1Magnesium Acetate
09 1Magnesium Acetate Tetrahydrate
10 1Magnesium Fluoride
11 1Magnesium Hydroxide
12 1Manganese Carbonate
13 1Phenol
14 1Potassium Acetate
15 1Potassium Bromide
16 1Potassium Chlorate
17 1Potassium Iodate
18 1Sodium Acetate
19 1Sodium Acetate Trihydrate
20 1Sodium Citrate
21 1Sodium Dihydrogen Phosphate Dihydrate
22 1Sodium Fluoride
23 1Sodium Molybdate
24 1Sodium Selenite
25 1Succinic Acid
26 1Zinc Acetate Dihydrate
27 1Zinc Oxide
01 2Active
02 25Blank
01 8Valid
02 19Blank
01 27Blank
01 27Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-04
Pay. Date : 2024-03-25
DMF Number : 39271
Submission : 2023-12-20
Status : Active
Type : II
Certificate Number : CEP 2018-028 - Rev 01
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 1139
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-326 - Rev 00
Issue Date : 2023-05-30
Type : Chemical
Substance Number : 7
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2017-233 - Rev 02
Issue Date : 2023-10-23
Type : Chemical
Substance Number : 118
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2017-280 - Rev 00
Issue Date : 2020-02-20
Type : Chemical
Substance Number : 2035
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2018-100 - Rev 01
Issue Date : 2024-06-03
Type : Chemical
Substance Number : 411
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-02
Pay. Date : 2021-06-02
DMF Number : 35887
Submission : 2021-05-11
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2017-177 - Rev 02
Issue Date : 2023-09-26
Type : Chemical
Substance Number : 194
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2016-103 - Rev 00
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 514
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2018-117 - Rev 01
Issue Date : 2023-02-02
Type : Chemical
Substance Number : 1482
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Quality Chemicals is a supplier offers 27 products (APIs, Excipients or Intermediates).
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