LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Aspen API
03 1Deccan Nutraceuticals Pvt. Ltd
04 1HRV Global Life Sciences
05 1Medichem S.A
06 3Neuland Laboratories
07 1TAPI Technology & API Services
08 1Angelini Pharma
09 1Aurobindo Pharma Limited
10 1Aurore Life Sciences
11 1Estechpharma
12 1Fujifilm Diosynth Biotechnologies
13 1Hetero Drugs
14 1KOLON Life Science, Inc
15 2Maithri Drugs
16 1Medilux Laboratories
17 2Megafine Pharma (P) Limited
18 1Micro Labs Limited
19 1Nifty Labs
20 1Ramdev Chemicals Pvt Ltd
21 1Sato Yakuhin Kogyo Co., Ltd
22 1Sms Lifesciences
23 1Sumitomo Chemical
24 1Sun Pharmaceutical Industries Limited
25 1Suzhou Hengyi Pharmaceutical
26 1Syn-Tech Chem. & Pharm
27 1Teva Pharmaceutical Industries
28 3Tianish Laboratories
29 2Viatris
30 2Zhejiang Liaoyuan Pharmaceutical Co LTD
01 3China
02 21India
03 2Israel
04 1Italy
05 2Japan
06 1Netherlands
07 2South Korea
08 1Spain
09 1Taiwan
10 3U.S.A
11 1United Kingdom
01 16Active
02 4Inactive
03 18Blank
01 15Valid
02 23Blank
01 1219MF10237
02 1229MF10101
03 1229MF10107
04 1229MF10115
05 1229MF10154
06 1229MF10155
07 1230MF10113
08 1301MF10005
09 30Blank
01 2WC-0016A2
02 1WC-0036
03 1WC-0037
04 1WC-0040A3
05 1WC-0087-(Annexure-1)
06 1WC-0119
07 1WC-0120
08 1WC-0168
09 1WC-0407
10 28Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10457
Submission : 1993-08-30
Status : Active
Type : II
Certificate Number : R1-CEP 2010-016 - Rev 03
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 219MF10237
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2007-07-17
Latest Date of Registration : --
NDC Package Code : 60870-0117
Start Marketing Date : 2008-07-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20220112-209-J-1207
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands
Available Reg Filing : ASMF, CN |
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-30
Pay. Date : 2013-04-17
DMF Number : 15749
Submission : 2001-12-05
Status : Active
Type : II
Certificate Number : R1-CEP 2007-178 - Rev 00
Issue Date : 2013-09-05
Type : Chemical
Substance Number : 2338
Status : Valid
NDC Package Code : 53296-0047
Start Marketing Date : 2010-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-02-04
Registration Number : 20220204-209-J-1227
Manufacturer Name : MEDICHEM SA
Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16007
Submission : 2002-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 2008-243 - Rev 05
Issue Date : 2022-12-19
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 301MF10005
Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India
Initial Date of Registration : 2019-05-15
Latest Date of Registration : --
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0121
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-01-12
Registration Number : 20201022-209-J-571(3)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15323
Submission : 2001-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24022
Submission : 2010-08-04
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-0121
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-01-12
Registration Number : 20201022-209-J-571(3)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-28
Pay. Date : 2023-11-24
DMF Number : 30850
Submission : 2016-09-07
Status : Active
Type : II
NDC Package Code : 58032-0121
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Medipoem Co., Ltd.
Registration Date : 2024-01-12
Registration Number : 20201022-209-J-571(3)
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India
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 : 8357
Submission : 1989-08-21
Status : Inactive
Type : II
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