LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 2Aarti Drugs
03 1Angelini Pharma
04 1DEAFARMA
05 1Emcure Pharmaceuticals
06 1Estechpharma
07 1Hoventa Pharma
08 1Ind Swift Laboratories Limited
09 1Merck Sante SAS
10 1Micro Labs Limited
11 1Nishchem International Pvt. Ltd
12 2Olon S.p.A
13 1Pramukh Pharmachem
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
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 : 2024-12-31
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
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
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2019-08-09
Valid Till : 2022-08-08
Written Confirmation Number : WC-253
Address of the Firm :
Date of Issue : 2019-08-09
Valid Till : 2022-08-08
Written Confirmation Number : WC-0253
Address of the Firm :
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Status : Withdrawn by EDQM F...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
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