LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1Gonane Pharma
03 1Granules India Limited
04 1Siegfried AG
05 1Acebright India Pharma Private Limited
06 1Ardena
07 1Arene Lifesciences
08 1Aspire Lifesciences Pvt Ltd
09 1Asymchem Laboratories
10 1Aurobindo Pharma Limited
11 1Catalent Pharma Solutions
12 1Chromo Laboratories
13 2Cipla
14 1Emcure Pharmaceuticals
15 1Globofarm International
16 2Hetero Drugs
17 1Laurus Labs
18 2Lupin Ltd
19 1MSN Laboratories
20 1Macleods Pharmaceuticals Limited
21 1Mana Pharma SL
22 2Mangalam Drugs & Organics Ltd
23 1Matrix Pharmaceutical Inc
24 1Nortec Quimica
25 1Olon S.p.A
26 1Raks Pharma
27 1SK Biotek
28 1ST Pharma
29 1ScinoPharm Taiwan Ltd
30 1Shanghai Desano Bio-Pharmaceutical
31 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
32 1Signa S.A. de C.V.
33 2Sun Pharmaceutical Industries Limited
34 1Tecoland Corporation
35 2Viatris
36 1Zhejiang Jiuzhou Pharmaceutical
37 3Blank
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01 1Belgium
02 1Brazil
03 4China
04 23India
05 1Italy
06 1Mexico
07 1South Korea
08 1Spain
09 1Switzerland
10 1Taiwan
11 7U.S.A
12 3Blank
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01 18Active
02 6Inactive
03 21Blank
01 7Valid
02 38Blank
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01 45Blank
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01 1WC-0015
02 1WC-0017
03 1WC-0022
04 1WC-0041
05 1WC-0065
06 1WC-0317
07 1WC-0395
08 2WC-0473
09 1WC-0487
10 35Blank
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01 1Su335-4-ND
02 1Su342-15-ND
03 43Blank
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01 111014-0175
02 114593-806
03 117337-0009
04 147621-050
05 150193-3264
06 150370-0049
07 152562-008
08 153104-7682
09 154245-7031
10 162207-005
11 165675-1003
12 165862-701
13 168554-0055
14 168554-0101
15 184206-0011
16 185247-0001
17 29Blank
01 45Blank
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32259
Submission : 2017-12-27
Status : Active
Type : II
Certificate Number : CEP 2020-279 - Rev 01
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2898
Status : Valid
NDC Package Code : 62207-005
Start Marketing Date : 2018-06-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
| Available Reg Filing : ASMF, MX |
NDC Package Code : 65675-1003
Start Marketing Date : 2019-02-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2021-03-16
Registration Number : Su342-15-ND
Manufacturer Name : Siegfried St. Vulbas SAS
Manufacturer Address : Parc Industriel de la Plaine de I`Ain 530 Allee de la Luye 01150 SAINT-VULBAS, France
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-04
Pay. Date : 2015-12-03
DMF Number : 29852
Submission : 2015-12-17
Status : Active
Type : II
NDC Package Code : 47621-050
Start Marketing Date : 2021-03-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-23
Pay. Date : 2017-01-05
DMF Number : 31229
Submission : 2017-03-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26672
Submission : 2012-11-20
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24970
Submission : 2011-05-24
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28565
Submission : 2015-01-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27876
Submission : 2013-12-31
Status : Inactive
Type : II

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A N349 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N349, including repackagers and relabelers. The FDA regulates N349 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N349 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 N349 supplier is an individual or a company that provides N349 active pharmaceutical ingredient (API) or N349 finished formulations upon request. The N349 suppliers may include N349 API manufacturers, exporters, distributors and traders.
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We have 36 companies offering N349
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