Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.

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01 2Comhony Biotech
02 1Shanghai Minbiotech
03 1Cerata Pharmaceuticals LLP
04 1Anhui Jingke Biotechnology
05 1Azelis
06 1Bills Biotech
07 1Concord Biotech
08 1Ercros
09 1HELM Portugal
10 1Hanways Chempharm
11 2JOYANG LABORATORIES
12 4Leo Pharma
13 1Panchsheel Organics
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01 8China
02 4Denmark
03 1France
04 4India
05 1Portugal
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01 5Active
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01 6Valid
02 1Withdrawn by Holder
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01 21Blank
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01 1FJ260011
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01 120240205-211-J-1605
02 120240205-211-J-1605(1)
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01 112836-0315
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Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33735
Submission : 2019-04-02
Status : Active
Type : II
Certificate Number : CEP 2022-330 - Rev 02
Issue Date : 2025-09-22
Type : Chemical
Substance Number : 798
Status : Valid
Date of Issue : 2024-03-13
Valid Till : 2029-03-04
Written Confirmation Number : FJ260011
Address of the Firm :
| Available Reg Filing : COPP |
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29081
Submission : 2015-01-31
Status : Active
Type : II
Certificate Number : CEP 2014-046 - Rev 01
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 798
Status : Valid
Registrant Name : Daeshin Muyak Co., Ltd.
Registration Date : 2024-10-07
Registration Number : 20240205-211-J-1605(1)
Manufacturer Name : Joyang Laboratories
Manufacturer Address : No.9, Haidu North Road, Sheyang Economic Development Zone

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20479
Submission : 2007-04-27
Status : Active
Type : II
Certificate Number : R1-CEP 2006-121 - Rev 02
Issue Date : 2021-11-17
Type : Chemical
Substance Number : 798
Status : Valid
NDC Package Code : 12836-0315
Start Marketing Date : 2018-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8526
Submission : 1990-04-16
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-379 - Rev 00
Issue Date : 2016-10-21
Type : Chemical
Substance Number : 798
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8528
Submission : 1990-04-16
Status : Inactive
Type : II
Certificate Number : CEP 2021-040 - Rev 02
Issue Date : 2026-05-12
Type : Chemical
Substance Number : 798
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8529
Submission : 1990-04-16
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-308 - Rev 02
Issue Date : 2022-01-19
Type : Chemical
Substance Number : 798
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8896
Submission : 1990-12-18
Status : Inactive
Type : II

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A Fucidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fucidine, including repackagers and relabelers. The FDA regulates Fucidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fucidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Fucidine supplier is an individual or a company that provides Fucidine active pharmaceutical ingredient (API) or Fucidine finished formulations upon request. The Fucidine suppliers may include Fucidine API manufacturers, exporters, distributors and traders.
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We have 15 companies offering Fucidine
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