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

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01 1Comhony Biotech
02 1Shanghai Minbiotech
03 1Willow Birch Pharma
04 2ACS DOBFAR SPA
05 1Abbott Laboratories
06 1Arena Pharmaceuticals Ltd
07 1Asia Pioneer Pharmaceuticals
08 1Bristol Myers Squibb
09 2Chongqing DaXin Pharmaceutical
10 1Interquim Mexico
11 1Kalchem International
12 1Letco Medical
13 1LifeFirst Pharma
14 1Pcca
15 1Qilu Pharmaceutical
16 2Qilu Tianhe Pharmaceutical Co., Ltd.
17 1Qingdao Qingmei Biotech
18 1Rephine
19 7Shandong Anxin Pharmaceutical
20 1Sichuan Renan Pharmaceutical
21 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
22 1Blank
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01 17China
02 1India
03 2Italy
04 1Mexico
05 6U.S.A
06 3United Kingdom
07 1Blank
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01 2Active
02 6Inactive
03 23Blank
01 2Valid
02 29Blank
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01 1222MF10057
02 1301MF10052
03 1307MF10133
04 28Blank
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01 31Blank
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01 120210625-210-J-1038
02 120210625-210-J-1038(1)
03 120210625-210-J-1038(2)
04 120210625-210-J-1038(3)
05 120210625-210-J-1038(4)
06 120210625-210-J-1038(5)
07 120210625-210-J-1038(6)
08 24Blank
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01 135369-0005
02 138779-0295
03 151927-0217
04 152946-0600
05 160592-007
06 162991-2002
07 166603-703
08 24Blank
01 31Blank
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 20874
Submission : 2007-09-18
Status : Active
Type : II
Registration Number : 307MF10133
Registrant's Address : No. 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan, Shandong Province, P. R. CHINA
Initial Date of Registration : 2025-10-29
Latest Date of Registration :

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 13763
Submission : 1998-09-01
Status : Active
Type : II
Registration Number : 301MF10052
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2019-08-28
Latest Date of Registration :
NDC Package Code : 52946-0600
Start Marketing Date : 2009-12-09
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 : 13722
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27776
Submission : 2013-11-27
Status : Inactive
Type : II
Certificate Number : CEP 2023-430 - Rev 01
Issue Date : 2025-09-11
Type : Chemical
Substance Number : 1290
Status : Valid
NDC Package Code : 66603-703
Start Marketing Date : 2018-04-03
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 : 22732
Submission : 2009-04-15
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13788
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21035
Submission : 2007-11-09
Status : Inactive
Type : II

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A Amukin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amukin, including repackagers and relabelers. The FDA regulates Amukin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amukin 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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