Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem High Potent SA
02 3Macfarlan Smith Ltd.
03 1Fine Chemicals Corporation
04 1Fine Chemicals Corporation (pty) Limited
05 2Arevipharma GmbH
06 1Hameln rds sro
07 1Kern Pharma SL
08 4Yichang Humanwell Pharmaceutical Co., Ltd.
01 1Aging Life Science Co., Ltd.
02 2Baeksu Pharmaceutical Co., Ltd.
03 2Fresenius Kabi Korea Co., Ltd.
04 1Ilsung IS Co., Ltd.
05 1Leaders Bio Co., Ltd.
06 1Mitsubishi Tanabe Pharma Korea Co., Ltd.
07 3Nosa Chemical Co., Ltd.
08 1Samoh Pharmaceutical Co., Ltd.
09 2Samung Industrial Co., Ltd.
01 14Remifentanil hydrochloride
01 4China
02 1France
03 2Germany
04 1Slovakia
05 2South Africa
06 1Spain
07 3U.S.A
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2014-10-28
Registration Number : Su2480-16-ND
Manufacturer Name : Minakem High Potent SA
Manufacturer Address : Rue Fonds Jean Paques 8, Mont-Saint-Guibert, 1435 Belgium
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom_x000D_
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-02-26
Registration Number : No. 181-3-ND(1)
Manufacturer Name : Fine Chemicals Corporation
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(2)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2014-09-02
Registration Number : Number 5-1-ND(1)
Manufacturer Name : Macfarlan Smith Ltd.
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2016-08-18
Registration Number : Su181-3-ND
Manufacturer Name : Fine Chemicals Corporation (...
Manufacturer Address : 15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2024-12-06
Registration Number : No. 75-4-ND(A)
Manufacturer Name : Arevipharma GmbH
Manufacturer Address : Meissner Str.35, D-01445 Radebeul, Germany
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2021-03-08
Registration Number : Su75-4-ND
Manufacturer Name : Arevipharma GmbH
Manufacturer Address : Meiβner Straβe 35, 01445 Radebeul, Deutschland
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2023-04-17
Registration Number : Number 9-1-ND
Manufacturer Name : Hameln rds sro
Manufacturer Address : Horná 36, 900 01 Modra, Slovak Republic
Registrant Name : Nosa Chemical Co., Ltd.
Registration Date : 2020-03-25
Registration Number : Su207-28-ND(3)
Manufacturer Name : Yichang Humanwell Pharmaceut...
Manufacturer Address : No. 19, Dalian Road, Yichang Developing zone, Hubei Province, China
A Ultiva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultiva, including repackagers and relabelers. The FDA regulates Ultiva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultiva 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 Ultiva manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ultiva supplier is an individual or a company that provides Ultiva active pharmaceutical ingredient (API) or Ultiva finished formulations upon request. The Ultiva suppliers may include Ultiva API manufacturers, exporters, distributors and traders.
click here to find a list of Ultiva 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 Ultiva Drug Master File in Korea (Ultiva KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultiva. The MFDS reviews the Ultiva KDMF as part of the drug registration process and uses the information provided in the Ultiva KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultiva 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 Ultiva API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultiva suppliers with KDMF on PharmaCompass.
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