01 1Inistesti Co., Ltd._x000D_ @Quzhou Aifeimu Chemicla Company Ltd. (Manufacturer of Dapoxetine Hydrochloride)
02 1Janssen Pharmaceutica NV
03 1Nosch Labs Pvt. Ltd@[Starting Material]Synergene Active Ingredients Pvt. Ltd.
04 1OLON SPA
01 1Inistesti Co., Ltd.
02 1Lee Sung International Co., Ltd.
03 2Menarini Korea Co., Ltd.
01 4dapoxetine hydrochloride
01 1India
02 1Italy
03 1South Korea
04 1U.S.A
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2013-01-04
Registration Number : 755-3-ND
Manufacturer Name : Inistesti Co., Ltd._x000D_ @...
Manufacturer Address : (369-901) Chungcheongbuk-do, Eumseong-gun, Geumwang-eup, Shinnae-ro 500_x000D_ _x000D...
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2008-08-29
Registration Number : Su217-4-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Janssen Pharmaceuticalaan 3B-2440 Geel, Belgium
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2015-12-18
Registration Number : No. 6410-3-ND
Manufacturer Name : Nosch Labs Pvt. Ltd@[Startin...
Manufacturer Address : Unit-Ⅱ, Sy. No. 14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangare...
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2018-02-21
Registration Number : 11-1-ND
Manufacturer Name : OLON SPA
Manufacturer Address : Via Livelli, 1(loc. FRAZIONE MAIRANO) - 26852 Casaletto Lodigiano, Italy
A Dapoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Dapoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapoxetine Hydrochloride 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 Dapoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapoxetine Hydrochloride supplier is an individual or a company that provides Dapoxetine Hydrochloride active pharmaceutical ingredient (API) or Dapoxetine Hydrochloride finished formulations upon request. The Dapoxetine Hydrochloride suppliers may include Dapoxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dapoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dapoxetine Hydrochloride Drug Master File in Korea (Dapoxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dapoxetine Hydrochloride. The MFDS reviews the Dapoxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dapoxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dapoxetine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dapoxetine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dapoxetine Hydrochloride suppliers with KDMF on PharmaCompass.
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