Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 2Bayer AG
03 2Catalent Pharma Solutions
04 1DEAFARMA
05 1Dasami Lab
06 1Hetero Drugs
07 1Lusochimica
08 1Shandong Xinhua Pharmaceutical
09 1Siegfried AG
10 1Sionc Pharmaceuticals
11 1UQUIFA
01 1China
02 2Germany
03 4India
04 2Italy
05 1Spain
06 1Switzerland
07 2U.S.A
01 4Active
02 4Inactive
03 5Blank
01 3Valid
02 1Withdrawn by Holder
03 9Blank
01 13Blank
01 1WC-0273
02 1WC-0578
03 11Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34203
Submission : 2019-12-03
Status : Active
Type : II
Certificate Number : R0-CEP 2020-353 - Rev 00
Issue Date : 2022-10-25
Type : Chemical
Substance Number : 1245
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-10-26
DMF Number : 32971
Submission : 2018-10-01
Status : Active
Type : II
Date of Issue : 2024-02-19
Valid Till : 2027-02-19
Written Confirmation Number : WC-0578
Address of the Firm :
NDC Package Code : 70966-0012
Start Marketing Date : 2008-01-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-31
Pay. Date : 2018-05-10
DMF Number : 16951
Submission : 2003-11-03
Status : Active
Type : II
Certificate Number : CEP 2004-272 - Rev 03
Issue Date : 2023-10-04
Type : Chemical
Substance Number : 1245
Status : Valid
NDC Package Code : 49711-0104
Start Marketing Date : 2009-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-12-18
Pay. Date : 2017-06-07
DMF Number : 14979
Submission : 2000-07-26
Status : Active
Type : II
Certificate Number : CEP 2022-403 - Rev 00
Issue Date : 2024-01-24
Type : Chemical
Substance Number : 1245
Status : Valid
NDC Package Code : 43898-0117
Start Marketing Date : 2000-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-534
Manufacturer Name : Lusochimica SpA
Manufacturer Address : Via Giotto 9, 23871 Lomagna (LC), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4664
Submission : 1982-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4816
Submission : 1982-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15598
Submission : 2001-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18373
Submission : 2005-05-24
Status : Inactive
Type : II
Certificate Number : R0-CEP 1999-105 - Rev 02
Issue Date : 2004-12-06
Type : Chemical
Substance Number : 1245
Status : Withdrawn by Holder
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0047
Start Marketing Date : 2019-07-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Nimodipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nimodipine, including repackagers and relabelers. The FDA regulates Nimodipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nimodipine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Nimodipine supplier is an individual or a company that provides Nimodipine active pharmaceutical ingredient (API) or Nimodipine finished formulations upon request. The Nimodipine suppliers may include Nimodipine API manufacturers, exporters, distributors and traders.
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