Delivering high-quality, innovative solutions with regulatory excellence for the healthcare and chemical industries worldwide.
01 1Pramukh Pharmachem
02 1LGM Pharma
03 2Aarti Drugs
04 1Angelini Pharma
05 1DEAFARMA
06 1Emcure Pharmaceuticals
07 1Estechpharma
08 1Hoventa Pharma
09 1Ind Swift Laboratories Limited
10 1Merck Sante SAS
11 1Micro Labs Limited
12 1Nishchem International Pvt. Ltd
13 2Olon S.p.A
14 1Sai Tech Pharmaceuticals Pvt Ltd
15 1Synthimed Labs
16 1Unipex
17 1Wuhan Wuyao Pharmaceutical
18 1Blank
01 1China
02 2France
03 10India
04 4Italy
05 1South Korea
06 1U.S.A
07 1Blank
01 5Active
02 3Inactive
03 12Blank
01 3Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 16Blank
01 20Blank
01 1WC-0003
02 1WC-0226
03 1WC-0253
04 1WC-253
05 16Blank
Delivering high-quality, innovative solutions with regulatory excellence for the healthcare and chemical industries worldwide.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-01-22
DMF Number : 25809
Submission : 2012-03-30
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-873
Start Marketing Date : 2022-10-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21348
Submission : 2008-02-20
Status : Active
Type : II
NDC Package Code : 50056-2006
Start Marketing Date : 2008-02-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 21481
Submission : 2008-03-24
Status : Active
Type : II
Date of Issue : 2022-06-03
Valid Till : 2025-05-27
Written Confirmation Number : WC-0003
Address of the Firm :
Registrant Name : Myungin Pharmaceutical Co., Ltd.
Registration Date : 2019-06-21
Registration Number : 20190213-209-J-97(1)
Manufacturer Name : Synthimed Labs Private Limited
Manufacturer Address : Village Bhagwanpur, Barwala Road, Derabassi-140507, District SAS Nagar (Mohali), Punjab, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21807
Submission : 2008-07-14
Status : Active
Type : II
Certificate Number : R1-CEP 2009-002 - Rev 07
Issue Date : 2021-01-15
Type : Chemical
Substance Number : 1585
Status : Valid
NDC Package Code : 17337-0002
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-13
Pay. Date : 2015-09-18
DMF Number : 22625
Submission : 2009-03-13
Status : Active
Type : II
NDC Package Code : 17337-0002
Start Marketing Date : 2012-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23973
Submission : 2010-08-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11995
Submission : 1996-06-10
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-125 - Rev 00
Issue Date : 2012-11-23
Type : Chemical
Substance Number : 1585
Status : Valid
Certificate Number : R1-CEP 2001-160 - Rev 02
Issue Date : 2008-08-28
Type : Chemical
Substance Number : 1585
Status : Withdrawn by EDQM F...
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2021-02-05
Registration Number : 20210205-211-J-830
Manufacturer Name : Estech Pharma Co., Ltd.
Manufacturer Address : 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, 34 Block 10-11, Balan Industrial Complex
Certificate Number : CEP 2008-200 - Rev 05
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 1585
Status : Valid
NDC Package Code : 65096-0112
Start Marketing Date : 2010-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-08-09
Valid Till : 2022-08-08
Written Confirmation Number : WC-253
Address of the Firm :
Date of Issue : 2022-08-08
Valid Till : 2025-08-09
Written Confirmation Number : WC-0253
Address of the Firm :
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 : 15819
Submission : 2002-01-23
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Acamprosate Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acamprosate Calcium, including repackagers and relabelers. The FDA regulates Acamprosate Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acamprosate Calcium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Acamprosate Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acamprosate Calcium supplier is an individual or a company that provides Acamprosate Calcium active pharmaceutical ingredient (API) or Acamprosate Calcium finished formulations upon request. The Acamprosate Calcium suppliers may include Acamprosate Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Acamprosate Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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