Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Metrochem API Private Limited
03 1Avantor Performance Materials
04 1GLAND PHARMA LIMITED
05 1Jost Chemical
06 1Macco Organiques Inc
07 1Macco Organiques, Spol. s.r o
08 1Meck Pharma
09 1TopChem Pharmaceuticals
01 1Canada
02 1Czech Republic
03 4India
04 1Ireland
05 2U.S.A
01 5Active
02 4Blank
01 2Valid
02 7Blank
01 9Blank
01 9Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-30
Pay. Date : 2022-09-23
DMF Number : 37324
Submission : 2022-07-15
Status : Active
Type : II
NDC Package Code : 73435-025
Start Marketing Date : 2022-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Certificate Number : CEP 2022-422 - Rev 01
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 111
Status : Valid
NDC Package Code : 42765-034
Start Marketing Date : 2022-05-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-26
Pay. Date : 2021-07-02
DMF Number : 35129
Submission : 2020-09-04
Status : Active
Type : II
NDC Package Code : 67706-0008
Start Marketing Date : 2015-02-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2023-10-11
Registration Number : 20231011-211-J-1550
Manufacturer Name : Macco Organiques, SRO
Manufacturer Address : Zahradni 46c, 792 01, Bruntal Czech Republic
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-30
Pay. Date : 2020-09-16
DMF Number : 34973
Submission : 2020-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32871
Submission : 2018-07-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-12
Pay. Date : 2021-01-21
DMF Number : 34856
Submission : 2020-08-11
Status : Active
Type : II
Certificate Number : R1-CEP 2015-375 - Rev 00
Issue Date : 2022-05-25
Type : Chemical
Substance Number : 111
Status : Valid
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