LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Akums Lifesciences
04 1Asia Pioneer Pharmaceuticals
05 2Aurobindo Pharma Limited
06 1Covalent Laboratories Private Limited
07 2Daiichi Sankyo
08 1Guangzhou Tosun Pharmaceutical
09 1Hanmi Pharmaceutical
10 1Jeil Pharmaceutical Co., Ltd
11 1Lupin Ltd
12 1Nectar Lifesciences
13 1Neha Chemicals
14 1Nishchem International Pvt. Ltd
15 1Orchid Pharma
16 1Orchidia Pharmaceutical Ind.
17 1Parabolic Drugs
18 3Qilu Antibiotics Pharmaceutical Co., Ltd.
19 1Qilu Pharmaceutical
20 1RANBAXY LABORATORIES LIMITED
21 2Sandoz B2B
22 1Sneha Medicare Pvt Ltd
23 1Virchow Group
24 1YUNGJIN PHARM. CO. LTD
01 5China
02 1Egypt
03 14India
04 2Japan
05 3South Korea
06 2Switzerland
07 2U.S.A
01 8Active
02 4Inactive
03 17Blank
01 7Valid
02 3Withdrawn by Holder
03 19Blank
01 1222MF10026
02 1223MF10157
03 1225MF10129
04 1227MF10122
05 1301MF10023
06 1303MF10058
07 1306MF10078
08 22Blank
01 1WC-0008
02 1WC-0120
03 1WC-0131
04 1WC-0145
05 1WC-0190
06 1WC-0202
07 1WC0131
08 22Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18941
Submission : 2005-10-31
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 59651-955
Start Marketing Date : 2024-03-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2018-08-30
Registration Number : 20180830-25-A-344-11
Manufacturer Name : Apitoria Pharma Private Limited, Unit IV
Manufacturer Address : Survey no.52, 53, 58, 59, 61 to 78, 127 ~ 128, Pydibhimavaram Village & 1,2,4 to 9,11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh state, India, 532409
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-09
Pay. Date : 2024-03-21
DMF Number : 39541
Submission : 2024-03-27
Status : Active
Type : II
NDC Package Code : 59651-955
Start Marketing Date : 2024-03-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2018-08-30
Registration Number : 20180830-25-A-344-11
Manufacturer Name : Apitoria Pharma Private Limited, Unit IV
Manufacturer Address : Survey no.52, 53, 58, 59, 61 to 78, 127 ~ 128, Pydibhimavaram Village & 1,2,4 to 9,11, 29, 30, 31 & 32, Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh state, India, 532409
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18505
Submission : 2005-07-11
Status : Active
Type : II
Registration Number : 306MF10078
Registrant's Address : Plot No. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, Tamilnadu, INDIA.
Initial Date of Registration : 2024-06-12
Latest Date of Registration : --
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-11
Pay. Date : 2014-06-18
DMF Number : 27071
Submission : 2014-06-14
Status : Active
Type : II
Certificate Number : R1-CEP 2015-354 - Rev 00
Issue Date : 2022-08-01
Type : Chemical
Substance Number : 2341
Status : Valid
Registration Number : 301MF10023
Registrant's Address : Village Saidpura, Tehsil Dera Bassi, District Sahibzada Ajit Singh Nagar-140 507, Punjab, INDIA
Initial Date of Registration : 2019-06-28
Latest Date of Registration : --
Date of Issue : 2016-09-06
Valid Till : 2019-07-02
Written Confirmation Number : WC-0145
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20076
Submission : 2006-12-26
Status : Active
Type : II
Certificate Number : R0-CEP 2013-064 - Rev 00
Issue Date : 2013-09-30
Type : Chemical
Substance Number : 2341
Status : Withdrawn by Holder
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140611-25-A-300-07(1)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 29791
Submission : 2015-09-14
Status : Active
Type : II
Date of Issue : 2019-09-03
Valid Till : 2022-09-03
Written Confirmation Number : WC-0190
Address of the Firm :
NDC Package Code : 61788-5000
Start Marketing Date : 2004-05-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2017-08-03
Registration Number : 20150410-25-A-305-10(1)
Manufacturer Name : Covalent Laboratories Pvt. Ltd
Manufacturer Address : Sy. No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, Telangana State,
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23572
Submission : 2010-02-23
Status : Active
Type : II
Certificate Number : R1-CEP 2011-165 - Rev 01
Issue Date : 2021-12-13
Type : Chemical
Substance Number : 2341
Status : Valid
Date of Issue : 2022-05-17
Valid Till : 2025-05-16
Written Confirmation Number : WC-0008
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-09
Pay. Date : 2020-01-21
DMF Number : 34502
Submission : 2020-02-17
Status : Active
Type : II
Certificate Number : R0-CEP 2020-399 - Rev 00
Issue Date : 2021-03-15
Type : Chemical
Substance Number : 2341
Status : Valid
Registration Number : 303MF10058
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2021-04-02
Latest Date of Registration : --
NDC Package Code : 51810-052
Start Marketing Date : 2022-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-07-01
Registration Number : 20200618-25-A-359-12(1)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6937
Submission : 1987-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9886
Submission : 1987-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16542
Submission : 2003-04-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-283 - Rev 01
Issue Date : 2017-12-05
Type : Chemical
Substance Number : 2341
Status : Valid
Registration Number : 225MF10129
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2013-07-09
Latest Date of Registration : --
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140611-25-A-300-07(1)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15192
Submission : 2000-12-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2010-186 - Rev 01
Issue Date : 2013-08-08
Type : Chemical
Substance Number : 2341
Status : Withdrawn by Holder
Registration Number : 222MF10026
Registrant's Address : Plot No. 90, Sector 32, Gurgaon, Haryana 122011, India
Initial Date of Registration : 2010-01-22
Latest Date of Registration : --
Certificate Number : R0-CEP 2019-319 - Rev 00
Issue Date : 2020-09-21
Type : Chemical
Substance Number : 2341
Status : Valid
NDC Package Code : 51810-052
Start Marketing Date : 2022-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-07-01
Registration Number : 20200618-25-A-359-12(1)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
NDC Package Code : 63785-112
Start Marketing Date : 2015-07-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2015-146 - Rev 00
Issue Date : 2022-04-14
Type : Chemical
Substance Number : 2341
Status : Valid
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2015-01-06
Registration Number : 20150106-25-A-308-09
Manufacturer Name : Jeil Pharmaceutical Co., Ltd.
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong and others)
Registration Number : 227MF10122
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2015-04-22
Latest Date of Registration : --
Registration Number : 223MF10157
Registrant's Address : S. C. O. 99-100, 3rd & 4th Floor, Sector 17-B, Chandigarh-160017, INDIA
Initial Date of Registration : 2011-11-02
Latest Date of Registration : --
Registrant Name : Essel Bio Co., Ltd.
Registration Date : 2013-12-27
Registration Number : 20120907-25-A-270-06(1)
Manufacturer Name : Parabolic Drugs Ltd
Manufacturer Address : Village Sundhran, Post office : Mubarakpur, Tehsil : Derabassi, District : Mohali, Punjab, India.
Date of Issue : 2019-07-05
Valid Till : 2022-07-04
Written Confirmation Number : WC-0202
Address of the Firm :
NDC Package Code : 57297-100
Start Marketing Date : 2020-09-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6316
Submission : 2019-07-18
Status : Active
Type : II
Certificate Number : R0-CEP 2012-166 - Rev 02
Issue Date : 2016-06-22
Type : Chemical
Substance Number : 2341
Status : Withdrawn by Holder
Certificate Number : CEP 2017-030 - Rev 01
Issue Date : 2023-10-09
Type : Chemical
Substance Number : 2341
Status : Valid
NDC Package Code : 51810-052
Start Marketing Date : 2022-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-07-01
Registration Number : 20200618-25-A-359-12(1)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
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