LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Aspen API
03 1Deccan Nutraceuticals Pvt. Ltd
04 1HRV Global Life Sciences
05 1Medichem S.A
06 3Neuland Laboratories
07 1Tenatra Chemie
08 1TAPI Technology & API Services
09 1Angelini Pharma
10 1Aurobindo Pharma Limited
11 1Aurore Life Sciences
12 1Estechpharma
13 1Fujifilm Diosynth Biotechnologies
14 1Hetero Drugs
15 1KOLON Life Science, Inc
16 2Liaoyuan Pharmaceutical
17 2Maithri Drugs
18 1Medilux Laboratories
19 2Megafine Pharma (P) Limited
20 1Micro Labs Limited
21 1Nifty Labs
22 1Ramdev Chemicals Pvt Ltd
23 1Sato Yakuhin Kogyo Co., Ltd
24 1Sms Lifesciences
25 1Sumitomo Chemical
26 1Sun Pharmaceutical Industries Limited
27 1Suzhou Hengyi Pharmaceutical
28 1Syn-Tech Chem. & Pharm
29 1Teva Pharmaceutical Industries
30 3Tianish Laboratories
31 2Viatris
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01 3China
02 22India
03 2Israel
04 1Italy
05 2Japan
06 1Netherlands
07 2South Korea
08 1Spain
09 1Taiwan
10 3U.S.A
11 1United Kingdom
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01 16Active
02 4Inactive
03 19Blank
01 15Valid
02 24Blank
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01 1219MF10237
02 1229MF10101
03 1229MF10107
04 1229MF10115
05 1229MF10154
06 1229MF10155
07 1230MF10113
08 1301MF10005
09 31Blank
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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 29Blank
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 : 2025-12-31
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 : 2025-12-31
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
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-12-13
Pay. Date : 2024-11-22
DMF Number : 31322
Submission : 2017-01-19
Status : Active
Type : II
Certificate Number : CEP 2018-225 - Rev 01
Issue Date : 2024-04-10
Type : Chemical
Substance Number : 2338
Status : Valid
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37013
Submission : 2022-03-30
Status : Active
Type : II
Certificate Number : CEP 2017-010 - Rev 01
Issue Date : 2024-06-17
Type : Chemical
Substance Number : 2338
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16113
Submission : 2002-08-22
Status : Active
Type : II
Certificate Number : R1-CEP 2010-293 - Rev 00
Issue Date : 2018-04-05
Type : Chemical
Substance Number : 2338
Status : Valid
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16490
Submission : 2003-03-28
Status : Active
Type : II
Certificate Number : CEP 2007-062 - Rev 04
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 2338
Status : Valid
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-316
Start Marketing Date : 2023-12-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-09
Registration Number : 20190405-209-J-202(2)
Manufacturer Name : Aurobindo Pharma Limited (Unit-I)
Manufacturer Address : Sy. No. 379, 385, 386, 388 to 396, Borpatla(V), Hatnoora(M), Sanga Reddy District, Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20570
Submission : 2007-05-28
Status : Active
Type : II
Certificate Number : R1-CEP 2008-214 - Rev 03
Issue Date : 2023-01-25
Type : Chemical
Substance Number : 2338
Status : Valid
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
Written Confirmation Number : WC-0087-(Annexure-1)
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23003
Submission : 2009-07-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-14
Pay. Date : 2023-09-29
DMF Number : 38799
Submission : 2023-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19369
Submission : 2006-04-14
Status : Active
Type : II
Date of Issue : 2020-03-20
Valid Till : 2022-06-26
Written Confirmation Number : WC-0016A2
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-27
Pay. Date : 2024-01-23
DMF Number : 38341
Submission : 2023-05-15
Status : Active
Type : II
Certificate Number : CEP 2023-188 - Rev 01
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 230MF10113
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA
Initial Date of Registration : 2018-08-22
Latest Date of Registration :
Date of Issue : 2022-02-25
Valid Till : 2022-07-03
Written Confirmation Number : WC-0040A3
Address of the Firm :
NDC Package Code : 65977-0137
Start Marketing Date : 1996-06-14
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 : 29748
Submission : 2015-08-31
Status : Active
Type : II
Registration Number : 229MF10115
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2017-06-30
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16014
Submission : 2002-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17521
Submission : 2004-07-13
Status : Inactive
Type : II
Date of Issue : 2020-03-20
Valid Till : 2022-06-26
Written Confirmation Number : WC-0016A2
Address of the Firm :
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15300
Submission : 2001-02-22
Status : Inactive
Type : II
Registration Number : 229MF10107
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2017-06-21
Latest Date of Registration :
Certificate Number : R0-CEP 2020-158 - Rev 01
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 2338
Status : Valid
Certificate Number : CEP 2008-205 - Rev 06
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2338
Status : Valid
NDC Package Code : 84206-0065
Start Marketing Date : 2024-09-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2009-399 - Rev 05
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2338
Status : Valid
NDC Package Code : 84206-0065
Start Marketing Date : 2024-09-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2008-141 - Rev 03
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 2338
Status : Valid
Certificate Number : R1-CEP 2009-180 - Rev 02
Issue Date : 2019-03-08
Type : Chemical
Substance Number : 2338
Status : Valid
Registration Number : 229MF10155
Registrant's Address : Zhejiang Provincial Chemical and Medical Raw Material Base Linhai Zone Duqiao town, Linhai City, Zhejiang Province, China
Initial Date of Registration : 2017-08-04
Latest Date of Registration :
Certificate Number : CEP 2019-127 - Rev 02
Issue Date : 2024-07-18
Type : Chemical
Substance Number : 2338
Status : Valid
NDC Package Code : 84206-0065
Start Marketing Date : 2024-09-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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