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 1Rochem International Inc
04 1Arde’s Laboratories
05 1Brother Enterprises Holding
06 1Divis Laboratories
07 1GE Healthcare Inc
08 1Global Calcium
09 1Grupo Juste
10 1Hengdian Group
11 1Hetero Drugs
12 1Hovione
13 1Interpharma Praha AS
14 1JRC
15 2ZHEJIANG TAIZHOU QINGQUAN MEDICAL & CHEM
16 1Zhejiang Haisen Pharmaceutical Co., Ltd.
17 2Zhejiang Starry Pharmaceutical Co., Ltd
01 7China
02 1Czech Republic
03 6India
04 1Portugal
05 1Spain
06 2U.S.A
07 1United Kingdom
01 2Active
02 3Inactive
03 14Blank
01 8Valid
02 1Withdrawn by Holder
03 10Blank
01 1217MF10959
02 1219MF10263
03 1227MF10106
04 1304MF10054
05 1305MF10075
06 14Blank
01 19Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-03
Pay. Date : 2023-03-23
DMF Number : 38195
Submission : 2023-03-20
Status : Active
Type : II
Certificate Number : CEP 2022-240 - Rev 00
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 1114
Status : Valid
NDC Package Code : 62331-066
Start Marketing Date : 2022-07-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Parmarine Co., Ltd.
Registration Date : 2022-05-17
Registration Number : 20220517-210-J-1297
Manufacturer Name : Divi's Laboratories Ltd.
Manufacturer Address : Unit-2, Chippada Village, Annavaram Post – 531 162, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh, INDIA
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-13
Pay. Date : 2021-09-14
DMF Number : 36038
Submission : 2021-09-15
Status : Active
Type : II
Certificate Number : R0-CEP 2021-313 - Rev 00
Issue Date : 2022-03-02
Type : Chemical
Substance Number : 1114
Status : Valid
NDC Package Code : 43228-100
Start Marketing Date : 1985-12-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Encomac Co., Ltd.
Registration Date : 2022-07-15
Registration Number : 20210308-210-J-719(2)
Manufacturer Name : Zhejiang Starry Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Starry Road, Xianju Modern Industrial Centralization Zone, Xianju County, Zhejiang, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26641
Submission : 2013-01-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-018 - Rev 02
Issue Date : 2014-09-02
Type : Chemical
Substance Number : 1114
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22535
Submission : 2009-02-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-018 - Rev 02
Issue Date : 2018-02-08
Type : Chemical
Substance Number : 1114
Status : Valid
Registration Number : 304MF10054
Registrant's Address : No. 1 Starry Road of Xianju Modern Industrial Centralization Zone, Xianju, Zhejiang, 317300, China
Initial Date of Registration : 2022-03-16
Latest Date of Registration : --
NDC Package Code : 43228-100
Start Marketing Date : 1985-12-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Encomac Co., Ltd.
Registration Date : 2022-07-15
Registration Number : 20210308-210-J-719(2)
Manufacturer Name : Zhejiang Starry Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Starry Road, Xianju Modern Industrial Centralization Zone, Xianju County, Zhejiang, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23148
Submission : 2009-10-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-044 - Rev 02
Issue Date : 2013-01-17
Type : Chemical
Substance Number : 1114
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2020-098 - Rev 00
Issue Date : 2021-10-28
Type : Chemical
Substance Number : 1114
Status : Valid
Registration Number : 217MF10959
Registrant's Address : Lindesnesveien 208, 4521 Lindesnes, Norway
Initial Date of Registration : 2005-11-14
Latest Date of Registration : --
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2020-07-17
Registration Number : 20200107-210-J-363(2)
Manufacturer Name : GE Healthcare AS
Manufacturer Address : Lindesnesveien 208, Lindesnes, NO-4521, Norway
Certificate Number : R1-CEP 2009-192 - Rev 02
Issue Date : 2020-05-20
Type : Chemical
Substance Number : 1114
Status : Valid
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