Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1LGM Pharma
03 1Symbiotec Pharmalab
04 1Gonane Pharma
05 1Medichem S.A
06 1Shanghai Minbiotech
07 1Fishfa Biogenics
08 1TAPI Technology & API Services
09 1Astellas Pharma
10 1Aurobindo Pharma Limited
11 1Biocon
12 2BrightGene Bio-Medical Technology Co.,Ltd
13 1Chongqing DaXin Pharmaceutical
14 1Concord Biotech
15 1Guangzhou Tosun Pharmaceutical
16 1Gufic Biosciences
17 2Hansoh Pharma
18 1Hetero Drugs
19 1Kaliberr Labs
20 1MSN Laboratories
21 1Mac-Chem Products (India) Pvt.Ltd
22 1Shanghai Techwell Biopharma
23 1Shenzhen Haorui
24 1Sumar Biotech
25 1Tecoland Corporation
26 1Tianwei Biotech Group
27 1Yacht Bio-Technology
28 1Yung Shin Pharmaceutical Industrial
29 1Zhejiang Hisun Pharmaceutical
30 1Zhejiang Huida Biotech
01 14China
02 13India
03 1Israel
04 1Japan
05 1Spain
06 2U.S.A
01 11Active
02 1Inactive
03 20Blank
01 32Blank
01 1229MF10162
02 1230MF10166
03 1230MF10169
04 1301MF10054
05 1303MF10069
06 27Blank
01 1WC-0100N1
02 1WC-0256
03 30Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-20
Pay. Date : 2016-06-02
DMF Number : 30558
Submission : 2016-06-06
Status : Active
Type : II
NDC Package Code : 16436-0114
Start Marketing Date : 2014-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-29
Pay. Date : 2018-05-14
DMF Number : 32812
Submission : 2018-06-17
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-23
Pay. Date : 2013-09-13
DMF Number : 27435
Submission : 2013-09-25
Status : Active
Type : II
NDC Package Code : 58623-0113
Start Marketing Date : 2018-04-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-03
Pay. Date : 2017-04-06
DMF Number : 31449
Submission : 2017-03-03
Status : Active
Type : II
Registration Number : 230MF10169
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2018-12-19
Latest Date of Registration : --
NDC Package Code : 62227-005
Start Marketing Date : 2014-07-10
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 : 12856
Submission : 1998-02-11
Status : Active
Type : II
Registrant Name : Astellas Pharma Korea Co., Ltd.
Registration Date : 2006-05-11
Registration Number : Number 118-1-ND
Manufacturer Name : Astellas Pharma Inc. Toyama Technology Center
Manufacturer Address : 2-178, Kojin-machi, Toyama-city, Toyama 930-0809, Japan (3-11, Nihenbashi-honcho 2chome, Chuo-ku, Tokyo 103-8411, Japan)
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-15
Pay. Date : 2024-09-05
DMF Number : 40132
Submission : 2024-08-16
Status : Active
Type : II
NDC Package Code : 65977-0150
Start Marketing Date : 2005-03-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-09-23
DMF Number : 30880
Submission : 2016-09-30
Status : Active
Type : II
Registration Number : 230MF10166
Registrant's Address : 20th KM, Hosur Road, Electronics City-560100, Bengaluru, India
Initial Date of Registration : 2018-12-10
Latest Date of Registration : --
Date of Issue : 2022-05-06
Valid Till : 2025-07-02
Written Confirmation Number : WC-0100N1
Address of the Firm :
NDC Package Code : 65727-055
Start Marketing Date : 2015-03-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-01
Pay. Date : 2020-08-07
DMF Number : 34888
Submission : 2020-07-31
Status : Active
Type : II
Registration Number : 301MF10054
Registrant's Address : No. 1191, Sec. 1, Chung Shan Rd. , Tachia, Taichung, Taiwan, R. O. C.
Initial Date of Registration : 2019-08-28
Latest Date of Registration : --
NDC Package Code : 63126-908
Start Marketing Date : 2020-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-06
Pay. Date : 2018-11-23
DMF Number : 33343
Submission : 2018-12-14
Status : Active
Type : II
NDC Package Code : 66529-0005
Start Marketing Date : 2018-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-09
Pay. Date : 2021-12-09
DMF Number : 36296
Submission : 2022-01-20
Status : Active
Type : II
NDC Package Code : 66529-0005
Start Marketing Date : 2018-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-06
Pay. Date : 2022-10-25
DMF Number : 35657
Submission : 2021-03-30
Status : Active
Type : II
NDC Package Code : 69766-090
Start Marketing Date : 2021-03-29
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 : 29662
Submission : 2015-09-29
Status : Inactive
Type : II
Registration Number : 303MF10069
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123
Initial Date of Registration : 2021-04-19
Latest Date of Registration : --
NDC Package Code : 62227-005
Start Marketing Date : 2014-07-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68254-0012
Start Marketing Date : 2014-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
A Micafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micafungin, including repackagers and relabelers. The FDA regulates Micafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micafungin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Micafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Micafungin supplier is an individual or a company that provides Micafungin active pharmaceutical ingredient (API) or Micafungin finished formulations upon request. The Micafungin suppliers may include Micafungin API manufacturers, exporters, distributors and traders.
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