Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1LGM Pharma
03 1Fermion Oy
04 1Jai Radhe Sales
05 1Cambrex Corporation
06 1Chemeca Drugs
07 1Credo Life Sciences
08 1DEAFARMA
09 1Daiwa Pharmaceuticals
10 1Darou Pakhsh Pharma Chem
11 1Divis Laboratories
12 2F.I.S. Fabbrica Italiana Sintetici
13 1Fleming Laboratories
14 1Hamari chemicals
15 1Lusochimica
16 1Maprimed
17 2Mitsubishi Tanabe Pharma
18 1Natco Pharma
19 1Nifty Labs
20 1Nishchem International Pvt. Ltd
21 1Osmopharm
22 1Pellets Pharma Limited
23 1Pellsys Pharma
24 2Piramal Pharma Solutions
25 1Qualitek pharma
26 1Sato Yakuhin Kogyo Co., Ltd
27 1Siegfried AG
28 1Spansules Pharma
29 1Syn-Tech Chem. & Pharm
30 1Teva API
31 1Teva Pharmaceutical Industries
32 1Titan Laboratories
33 1Yoshindo
34 1Zim Laboratories
35 4Blank
01 1Argentina
02 1Finland
03 1Germany
04 15India
05 1Iran
06 2Israel
07 4Italy
08 5Japan
09 2Switzerland
10 1Taiwan
11 4U.S.A
12 4Blank
01 8Active
02 12Inactive
03 21Blank
01 7Valid
02 1Withdrawn by Holder
03 33Blank
01 1218MF10126
02 1219MF10031
03 1221MF10252
04 1225MF10001
05 1229MF10062
06 36Blank
01 1WC-0002
02 1WC-0031
03 1WC-0123
04 1WC-0229
05 37Blank
Certificate Number : R1-CEP 1998-115 - Rev 05
Issue Date : 2018-06-29
Type : Chemical
Substance Number : 1004
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-12-29
DMF Number : 5717
Submission : 1985-02-06
Status : Active
Type : II
NDC Package Code : 12780-2960
Start Marketing Date : 1985-02-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-06
Pay. Date : 2013-01-31
DMF Number : 14713
Submission : 2000-01-27
Status : Active
Type : II
Certificate Number : R1-CEP 1997-121 - Rev 14
Issue Date : 2022-01-07
Type : Chemical
Substance Number : 1004
Status : Valid
Registration Number : 221MF10252
Registrant's Address : Digwal Village (Sy.Nos.7-70, 70/1 and 70/2), Kohir Mandal, Sangareddy District-502 321, Telangana, India
Initial Date of Registration : 2009-11-24
Latest Date of Registration : --
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0002
Start Marketing Date : 2015-05-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pampia Co., Ltd.
Registration Date : 2021-09-24
Registration Number : 20210310-209-J-866(1)
Manufacturer Name : Piramal Pharma Limited
Manufacturer Address : Sy. Nos. 7-70, 70/1 & 70/2 Digwal Village, Kohir Mandal Sangareddy District - 502 321, Telangana, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-09
Pay. Date : 2020-02-11
DMF Number : 34220
Submission : 2020-02-15
Status : Active
Type : II
NDC Package Code : 77777-110
Start Marketing Date : 2019-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3059
Submission : 1977-11-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-177 - Rev 05
Issue Date : 2015-10-19
Type : Chemical
Substance Number : 1004
Status : Withdrawn by Holder
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2022-10-20
Registration Number : 20221020-209-J-1386
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd.
Manufacturer Address : 7473-2, Ooaza Onoda, Sanyoonoda, Yamaguchi 756-0054, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10381
Submission : 1993-07-09
Status : Inactive
Type : II
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2022-10-20
Registration Number : 20221020-209-J-1386
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd.
Manufacturer Address : 7473-2, Ooaza Onoda, Sanyoonoda, Yamaguchi 756-0054, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8548
Submission : 1990-05-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14659
Submission : 2000-01-06
Status : Inactive
Type : II
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