Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Evonik
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 1Lifecare Laboratories Pvt Ltd
06 1Pfanstiehl
07 1AMINO GmbH
08 3Ajinomoto Company
09 1BD BIOSCIENCES ADVANCED BIOPROCESSING
10 1Cytiva
11 1Daizo Corporation
12 1Emmaus Life Sciences
13 1Hangzhou Think Chemical Co.Ltd
14 6HyClone Laboratories Inc.
15 2Irvine Scientific Sales Company
16 1Katayama Seiyakusyo
17 1Kyowa Hakko Bio
18 1Mitsubishi Tanabe Pharma
19 26SAFC
20 1Sichuan Tongsheng Amino Acid Co., Ltd
21 1Summit Ingredients
22 1Yangzhou Gami Biochem Co. Ltd
23 1Blank
01 4China
02 2Germany
03 4India
04 7Japan
05 38U.S.A
06 1Blank
01 13Active
02 28Inactive
03 15Blank
01 56Blank
01 1217MF10597
02 1220MF10239
03 1220MF10245
04 1226MF40022
05 1229MF40044
06 1301MF40012
07 1303MF40064
08 1303MF40065
09 1303MF40066
10 1304MF40011
11 1304MF40012
12 45Blank
01 1WC-0416
02 55Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37695
Submission : 2022-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9486
Submission : 1992-01-03
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38992
Submission : 2023-12-28
Status : Active
Type : II
NDC Package Code : 42765-050
Start Marketing Date : 2022-09-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-22
Pay. Date : 2021-08-25
DMF Number : 36082
Submission : 2021-08-26
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-080
Start Marketing Date : 2020-09-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10565
Submission : 1993-11-12
Status : Active
Type : II
Registration Number : 304MF40011
Registrant's Address : Second Avenue Heatherhouse Industrial Estate Irvine, Scotland, United Kingdom KA12 8NB
Initial Date of Registration : 2022-03-10
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11013
Submission : 1994-08-02
Status : Inactive
Type : II
Registration Number : 304MF40012
Registrant's Address : 13804 West 107th Street Lenexa, Kansas 66215 USA
Initial Date of Registration : 2022-03-10
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11314
Submission : 1994-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15120
Submission : 2000-11-01
Status : Inactive
Type : II
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