LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1DKSH
03 1Fareva
04 1Jai Radhe Sales
05 1Octavius Pharma Pvt. Ltd
06 1Shanghai Minbiotech
07 2Chunghwa Chemical Synthesis & Biotech
08 2Apotex Pharmachem
09 1Arevipharma
10 2Biocon
11 1Biotechnica DWC
12 1CKD Bio Corporation
13 2Chongqing DaXin Pharmaceutical
14 1Cipla
15 2Concord Biotech
16 1Dasami Lab
17 1Emcure Pharmaceuticals
18 1Formosa Laboratories
19 1HAUDONG MEDICINE CO LTD
20 1Hetero Drugs
21 1Hunan Warrant Chiral Pharmaceutical
22 1IVAX Pharmaceuticals Inc
23 2Lek Pharmaceuticals
24 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
25 1Livzon New North River Pharmaceutical
26 1Lunan Pharmaceutical
27 1Murli Krishna Pharma
28 1Olon S.p.A
29 1RPG Life Sciences Ltd.
30 1Rakshit Drugs
31 1Solara Active Pharma Sciences
32 1Srini Pharmaceuticals
33 1Sumar Biotech
34 1Tecoland Corporation
35 1Teva API
36 1Teva Pharmaceutical Industries
37 2Wuxi Fortune Pharmaceutical Co., Ltd
38 2Zhejiang Hisun Pharmaceutical
39 1Blank
01 1Algeria
02 2Canada
03 12China
04 1Germany
05 16India
06 2Israel
07 1Italy
08 1Luxembourg
09 2Slovenia
10 1South Korea
11 1Switzerland
12 3Taiwan
13 3U.S.A
14 1Blank
01 16Active
02 13Inactive
03 18Blank
01 15Valid
02 3Withdrawn by Holder
03 29Blank
01 1224MF10054
02 1224MF10107
03 45Blank
01 1WC-0056
02 1WC-0109
03 1WC-0111
04 1WC-0128
05 1WC-0197
06 1WC-0226
07 1WC-0290A3
08 1WC-0405
09 1WC-304
10 38Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21079
Submission : 2007-11-28
Status : Active
Type : II
NDC Package Code : 46014-1123
Start Marketing Date : 2007-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-11-22
DMF Number : 18494
Submission : 2005-07-11
Status : Active
Type : II
NDC Package Code : 52076-6220
Start Marketing Date : 2018-01-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-01
Pay. Date : 2018-12-04
DMF Number : 33333
Submission : 2018-12-07
Status : Active
Type : II
NDC Package Code : 52076-6220
Start Marketing Date : 2018-01-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-21
Pay. Date : 2019-08-23
DMF Number : 33934
Submission : 2019-08-02
Status : Active
Type : II
Certificate Number : R1-CEP 2008-298 - Rev 02
Issue Date : 2020-04-02
Type : Chemical
Substance Number : 1700
Status : Valid
NDC Package Code : 65050-2101
Start Marketing Date : 2021-01-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22786
Submission : 2009-05-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2019-159 - Rev 00
Issue Date : 2020-11-30
Type : Chemical
Substance Number : 1700
Status : Valid
NDC Package Code : 65050-2101
Start Marketing Date : 2021-01-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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