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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
NDC Package Code : 46016-0140
Start Marketing Date : 2003-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
Certificate Number : CEP 2022-094 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 1759
Status : Valid
Date of Issue : 2019-07-29
Valid Till : 2022-07-29
Written Confirmation Number : WC-0445
Address of the Firm :
NDC Package Code : 71554-012
Start Marketing Date : 2019-04-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribidanur, Chikkaballapur Dist., Karnataka-561 208, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-22
Written Confirmation Number : WC-0139
Address of the Firm :
NDC Package Code : 71554-012
Start Marketing Date : 2019-04-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribidanur, Chikkaballapur Dist., Karnataka-561 208, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
NDC Package Code : 22568-1022
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7837
Submission : 1988-12-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
NDC Package Code : 46016-0140
Start Marketing Date : 2003-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7108
Submission : 1987-08-11
Status : Inactive
Type : II
57
PharmaCompass offers a list of Orphenadrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Orphenadrine manufacturer or Orphenadrine supplier for your needs.
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A Orphenadrine Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine Citrate, including repackagers and relabelers. The FDA regulates Orphenadrine Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine Citrate 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 Orphenadrine Citrate supplier is an individual or a company that provides Orphenadrine Citrate active pharmaceutical ingredient (API) or Orphenadrine Citrate finished formulations upon request. The Orphenadrine Citrate suppliers may include Orphenadrine Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Orphenadrine Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 12 companies offering Orphenadrine Citrate
Get in contact with the supplier of your choice: