01 1Daito Pharmaceutical
02 1Laboratori Alchemia Srl
03 1Permachem Asia, Ltd
04 1Shiratori Pharmaceutical
05 1Unipex
01 1France
02 1Italy
03 3Japan
01 1Active
02 4Blank
01 5Blank
01 1217MF11139
02 1228MF10218
03 1230MF10017
04 2Blank
01 5Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11759
Submission : 1995-11-29
Status : Active
Type : II
Registration Number : 230MF10017
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2018-02-05
Latest Date of Registration : --
NDC Package Code : 12863-100
Start Marketing Date : 1998-02-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2022-02-08
Registration Number : 20220208-209-J-1230
Manufacturer Name : Shiratori Pharmaceutical Co., Ltd.@Nipro Pharma Corporation
Manufacturer Address : 54 Shinminato, Mihama-ku, Chiba-shi, Chiba, Japan@2-1, Minamisakae-cho, Kasukabe-shi, Saitama, Japan
Registration Number : 228MF10218
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2016-11-15
Latest Date of Registration : --
Registration Number : 217MF11139
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : --
A Emedastine Difumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emedastine Difumarate, including repackagers and relabelers. The FDA regulates Emedastine Difumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emedastine Difumarate 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 Emedastine Difumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emedastine Difumarate supplier is an individual or a company that provides Emedastine Difumarate active pharmaceutical ingredient (API) or Emedastine Difumarate finished formulations upon request. The Emedastine Difumarate suppliers may include Emedastine Difumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Emedastine Difumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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