Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1LGM Pharma
03 1Supriya Lifescience
04 1Capital Farma
05 1Almelo
06 1Bayer AG
07 1Beijing Beilu Pharma
08 1BrightGene Bio-Medical Technology Co.,Ltd
09 1Divis Laboratories
10 1Dongkook Lifescience
11 1Estechpharma
12 1Farmak JSC
13 1Formosa Laboratories
14 1Guangzhou Tosun Pharmaceutical
15 1Hainan Poly Pharm
16 1JRC
17 1Jiangsu Hengrui Medicine
18 1Lewens Labs
19 1MSN Laboratories
20 1ST Pharma
21 1Seven Star Pharmaceutical
22 1Sichuan Qingmu Pharmaceutical
23 1Sichuan Renan Pharmaceutical
24 2Sionc Pharmaceuticals
25 1Viwit Pharmaceuticals Limited
26 1Yangtze River Pharmaceutical Group
27 1Blank
01 9China
02 1Germany
03 9India
04 3South Korea
05 1Spain
06 2Taiwan
07 1U.S.A
08 1Ukraine
09 1Blank
01 10Active
02 18Blank
01 4Valid
02 24Blank
01 1305MF10082
02 27Blank
01 1WC-0273
02 1WC-0273A7
03 26Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 33420
Submission : 2019-09-10
Status : Active
Type : II
Certificate Number : R0-CEP 2019-307 - Rev 01
Issue Date : 2023-06-08
Type : Chemical
Substance Number : 2735
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-25
Pay. Date : 2023-08-29
DMF Number : 36996
Submission : 2022-03-31
Status : Active
Type : II
NDC Package Code : 72640-022
Start Marketing Date : 2022-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38579
Submission : 2023-08-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-06-19
Pay. Date : 2020-04-29
DMF Number : 34832
Submission : 2020-05-28
Status : Active
Type : II
NDC Package Code : 57884-0035
Start Marketing Date : 2020-05-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-30
Pay. Date : 2021-02-26
DMF Number : 35662
Submission : 2021-02-26
Status : Active
Type : II
Certificate Number : R0-CEP 2020-015 - Rev 01
Issue Date : 2022-11-28
Type : Chemical
Substance Number : 2735
Status : Valid
NDC Package Code : 73675-002
Start Marketing Date : 2023-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2018-07-10
Registration Number : 1301-7-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-09
Pay. Date : 2024-07-25
DMF Number : 39094
Submission : 2023-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40533
Submission : 2024-09-23
Status : Active
Type : II
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