LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Gonane Pharma
03 1Acebright India Pharma Private Limited
04 1Arene Lifesciences
05 1Aspire Lifesciences Pvt Ltd
06 2Aurobindo Pharma Limited
07 1Cdymax
08 1Chromo Laboratories
09 1Cipla
10 3Hetero Drugs
11 1Kopalle Pharma Chemicals
12 2Laurus Labs
13 2Lupin Ltd
14 1NEWEDGE Overseas
15 1Olon S.p.A
16 1Piramal Pharma Solutions
17 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
18 1Signa S.A. de C.V.
19 1Sinopharm Weiqida Pharmaceutical Co Ltd
20 1Synthland
21 1Tecoland Corporation
22 3Viatris
23 1Blank
01 3China
02 18India
03 1Italy
04 1Mexico
05 6U.S.A
06 1Blank
01 11Active
02 1Inactive
03 18Blank
01 10Valid
02 20Blank
01 1229MF10171
02 29Blank
01 1WC-0015
02 1WC-0023
03 1WC-0041
04 1WC-0065
05 1WC-0065a
06 1WC-0123
07 1WC-0140
08 1WC-0201
09 1WC-0213
10 1WC-0359
11 1WC-0359a3
12 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.
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 : Unit VIII, G Chodevaram (V), Pusapatirega (Mandal), Vizianagaram Dist.,-535204, AP
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 : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakhapatnam 531021, Andhra Pradesh India
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 : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 22196
Submission : 2008-11-17
Status : Active
Type : II
Certificate Number : R1-CEP 2016-090 - Rev 00
Issue Date : 2023-01-27
Type : Chemical
Substance Number : 2589
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, A.P
NDC Package Code : 68554-0032
Start Marketing Date : 1998-12-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-27
Pay. Date : 2015-12-21
DMF Number : 29587
Submission : 2015-07-24
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0065
Address of the Firm : (Unit-IX), Plot No. 2, Hetero Infra structure SEZ Ltd, Nrasapuram Village, Nakkapally Mandal, Visakhapatnam Dist, A.P
NDC Package Code : 68554-0032
Start Marketing Date : 1998-12-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2013-141 - Rev 01
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 2589
Status : Valid
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