EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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01 1EUROAPI
02 1Transo-Pharm USA LLC
03 1Omgene Life Sciences Pvt. Ltd
04 1Agilent Technologies
05 1Anhui Ribobay Pharmaceutical Co.,Ltd
06 1Apextide
07 1Aurisco Pharmaceutical
08 1Gyma Laboratories of America
09 1Jiangsu Sinopep Allsino Biopharmaceutical
10 1Novartis Pharmaceuticals Corporation
11 1ST Pharma
12 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
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01 5China
02 1France
03 1India
04 1South Korea
05 1Switzerland
06 3U.S.A
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01 2Active
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01 1Su196-29-ND
02 1Su196-34-ND
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01 142931-712
02 170596-1002
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41776
Submission : 2025-04-15
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-23
Pay. Date : 2025-09-25
DMF Number : 42095
Submission : 2025-09-24
Status : Active
Type : II


USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2026-02-25
Registration Number : Su196-34-ND
Manufacturer Name : Novartis Pharma Schweizerhalle AG
Manufacturer Address : Rothausstrasse, 4133, Pratteln, Switzerland


Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2024-06-20
Registration Number : Su196-29-ND
Manufacturer Name : ST Pharm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do


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