LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Gonane Pharma
03 1Granules India Limited
04 1Acebright India Pharma Private Limited
05 1Arene Lifesciences
06 1Aspire Lifesciences Pvt Ltd
07 2Aurobindo Pharma Limited
08 1Cdymax
09 1Chromo Laboratories
10 1Cipla
11 3Hetero Drugs
12 1Kopalle Pharma Chemicals
13 2Laurus Labs
14 2Lupin Ltd
15 1NEWEDGE Overseas
16 1Olon S.p.A
17 1Piramal Pharma Solutions
18 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
19 1Signa S.A. de C.V.
20 1Sinopharm Weiqida Pharmaceutical Co Ltd
21 1Synthland
22 1Tecoland Corporation
23 1Tianish Laboratories
24 3Viatris
01 3China
02 20India
03 1Italy
04 1Mexico
05 6U.S.A
01 11Active
02 1Inactive
03 19Blank
01 10Valid
02 21Blank
01 1229MF10171
02 30Blank
01 1WC-0015
02 1WC-0023
03 1WC-0024
04 1WC-0041
05 1WC-0065
06 1WC-0065a
07 1WC-0123
08 1WC-0140
09 1WC-0201
10 1WC-0213
11 1WC-0359
12 1WC-0359a3
13 19Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-29
Pay. Date : 2013-03-13
DMF Number : 26299
Submission : 2012-08-22
Status : Active
Type : II
Certificate Number : R1-CEP 2014-187 - Rev 00
Issue Date : 2021-01-20
Type : Chemical
Substance Number : 2589
Status : Valid
Date of Issue : 2022-06-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0140
Address of the Firm :
NDC Package Code : 53104-7558
Start Marketing Date : 2018-04-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-05-11
DMF Number : 18229
Submission : 2005-03-30
Status : Active
Type : II
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-640
Start Marketing Date : 2015-02-13
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 : 20515
Submission : 2007-05-08
Status : Active
Type : II
NDC Package Code : 17337-0001
Start Marketing Date : 2012-12-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-20
Pay. Date : 2014-11-21
DMF Number : 28818
Submission : 2014-12-15
Status : Active
Type : II
Certificate Number : R1-CEP 2014-353 - Rev 01
Issue Date : 2023-02-15
Type : Chemical
Substance Number : 2589
Status : Valid
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-27
Pay. Date : 2018-08-23
DMF Number : 33031
Submission : 2018-08-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2014-07-07
DMF Number : 23644
Submission : 2010-03-19
Status : Active
Type : II
Certificate Number : R0-CEP 2020-198 - Rev 00
Issue Date : 2022-07-12
Type : Chemical
Substance Number : 2589
Status : Valid
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