LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Bal Pharma
03 1Polpharma
04 1HRV Global Life Sciences
05 2Alembic Pharmaceuticals Limited
06 1Alkaloida Chemical Company Zrt
07 1Apotex Pharmachem
08 1Aurobindo Pharma Limited
09 1Beloorbayir Biotech
10 1Biotechnica DWC
11 1Cilag AG
12 1Cipla
13 2Dishman Carbogen Amcis
14 1Divis Laboratories
15 1Enaltec Labs Private Limited
16 1Estechpharma
17 1Fleming Laboratories
18 1Glenmark Life Sciences
19 1Glenmark Pharmaceuticals
20 1Global Calcium
21 1Globe Quimica Ltda
22 1Glochem Industries
23 1Guangzhou Tosun Pharmaceutical
24 1Hengdian Group
25 1Hermes Chemical
26 2Hetero Drugs
27 2Ildong Pharmaceutical
28 1Johnson & Johnson Innovative Medicine
29 1Lupin Ltd
30 2MSN Laboratories
31 1Maithri Drugs
32 2Nifty Labs
33 1Nishchem International Pvt. Ltd
34 1ScinoPharm Taiwan, Ltd
35 1Shodhana Laboratories Pvt. Ltd
36 1Siegfried AG
37 1Signa S.A. de C.V.
38 1Sun Pharmaceutical Industries Limited
39 1Therapiva
40 1Torrent Pharmaceuticals Limited
41 1Unichem Laboratories Limited
42 2Unimark Remedies Limited
43 1Zhejiang Huahai Pharmaceutical
44 1Zydus Lifesciences
01 1Algeria
02 1Brazil
03 1Canada
04 3China
05 1Hungary
06 34India
07 1Mexico
08 1Poland
09 3South Korea
10 2Switzerland
11 1Taiwan
12 2U.S.A
01 16Active
02 9Inactive
03 26Blank
01 4Valid
02 47Blank
01 1220MF10001
02 1227MF10206
03 1227MF10208
04 1229MF10116
05 1301MF10026
06 1301MF10073
07 45Blank
01 1WC-0026
02 1WC-0029
03 1WC-0040
04 1WC-0057n
05 1WC-0066
06 1WC-0084
07 1WC-0104A5-A6
08 1WC-0113
09 1WC-0120
10 1WC-0156
11 1WC-0168
12 1WC-0170
13 1WC-0281A3
14 1WC-0281new2
15 1WC-0316n
16 1WC-0455
17 1WC-316
18 34Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0156
Address of the Firm :
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2016-12-07
Registration Number : 20130912-170-I-365-10(2)
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : No.61-B, Bommasandra Industrial Area, Bangalore-560 099, India.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-03
Pay. Date : 2013-05-21
DMF Number : 20581
Submission : 2007-06-06
Status : Active
Type : II
NDC Package Code : 12658-0410
Start Marketing Date : 1996-12-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Myungin Pharmaceutical Co., Ltd.
Registration Date : 2020-01-13
Registration Number : 20130117-170-I-185-05(6)
Manufacturer Name : Pharmaceutical Works Polpharma S.A.
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39636
Submission : 2024-03-14
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2022-07-07
Written Confirmation Number : WC-0104A5-A6
Address of the Firm :
NDC Package Code : 64162-0339
Start Marketing Date : 2023-03-13
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 : 20386
Submission : 2007-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17035
Submission : 2003-12-16
Status : Active
Type : II
Registration Number : 301MF10073
Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
Initial Date of Registration : 2019-10-08
Latest Date of Registration : --
NDC Package Code : 54245-1024
Start Marketing Date : 2002-12-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2019-05-30
Registration Number : 20190530-170-I-277-19
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No.1, Nan-Ke 8th Road Shan-Hua, Tainan 74144 Taiwan
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-24
Pay. Date : 2020-09-18
DMF Number : 35191
Submission : 2020-09-28
Status : Active
Type : II
NDC Package Code : 53747-097
Start Marketing Date : 2020-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-27
Pay. Date : 2017-08-22
DMF Number : 25713
Submission : 2012-01-05
Status : Active
Type : II
Certificate Number : R0-CEP 2020-201 - Rev 01
Issue Date : 2022-03-02
Type : Chemical
Substance Number : 2616
Status : Valid
Date of Issue : 2020-04-15
Valid Till : 2023-05-19
Written Confirmation Number : WC-0281new2
Address of the Firm :
NDC Package Code : 50379-0007
Start Marketing Date : 2012-06-21
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 : 21657
Submission : 2008-05-26
Status : Inactive
Type : II
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