LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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01 1LGM Pharma
02 1Transo-Pharm Handels GmbH
03 1Aspen API
04 1Deccan Nutraceuticals Pvt. Ltd
05 1HRV Global Life Sciences
06 1Medichem S.A
07 3Neuland Laboratories
08 1Tenatra Chemie
09 1TAPI Technology & API Services
10 1Angelini Pharma
11 1Aurobindo Pharma Limited
12 1Aurore Life Sciences
13 1Estechpharma
14 1Fujifilm Diosynth Biotechnologies
15 1Hetero Drugs
16 1KOLON Life Science, Inc
17 2Liaoyuan Pharmaceutical
18 2Maithri Drugs
19 1Medilux Laboratories
20 2Megafine Pharma (P) Limited
21 1Micro Labs Limited
22 1Nifty Labs
23 1Ramdev Chemicals Pvt Ltd
24 1Sato Yakuhin Kogyo Co., Ltd
25 1Sms Lifesciences
26 1Sumitomo Chemical
27 1Sun Pharmaceutical Industries Limited
28 1Suzhou Hengyi Pharmaceutical
29 1Syn-Tech Chem. & Pharm
30 1Teva Pharmaceutical Industries
31 3Tianish Laboratories
32 2Viatris
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01 3China
02 1Germany
03 22India
04 2Israel
05 1Italy
06 2Japan
07 1Netherlands
08 2South Korea
09 1Spain
10 1Taiwan
11 3U.S.A
12 1United Kingdom
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01 16Active
02 4Inactive
03 20Blank
01 15Valid
02 25Blank
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01 1219MF10237
02 1229MF10101
03 1229MF10107
04 1229MF10115
05 1229MF10154
06 1229MF10155
07 1230MF10113
08 1301MF10005
09 32Blank
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01 1TFDA-0002291
02 2WC-0016A2
03 1WC-0036
04 1WC-0037
05 1WC-0040A3
06 1WC-0087-(Annexure-1)
07 1WC-0119
08 1WC-0120
09 1WC-0168
10 1WC-0407
11 29Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Date of Issue : 2022-02-22
Valid Till : 2025-07-15
Written Confirmation Number : TFDA-0002291
Address of the Firm :
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 : 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 : 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 : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2019-04-05
Registration Number : 20190405-209-J-202
Manufacturer Name : Apitoria Pharma Private Ltd. Unit-1
Manufacturer Address : Sy.No. 379, 385, 386, 388 to 396, Borpatla Village, Hathnoora Mandal, Sanga reddy District, Telangana, India. 502296
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 :
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 : 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 :
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 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 : R0-CEP 2020-158 - Rev 01
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 2338
Status : Valid
Certificate Number : R1-CEP 2008-141 - Rev 03
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 2338
Status : Valid
Certificate Number : CEP 2019-127 - Rev 03
Issue Date : 2025-02-06
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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