01 1Excella GmbH & Co. KG
02 1Ampac Fine Chemicals
03 1Formosa Laboratories, Inc. Louchu Plant@[Starting Material Manufacturing Plant]Azide Chemical Co., Ltd._x000D_ _x000D_
04 3Shilpa Pharma Lifesciences Limited
05 1Sun Pharmaceutical Industries Ltd
01 1Alvogen Korea Co., Ltd.
02 1Hwail Pharmaceutical Co., Ltd.
03 1Korea MSD Co., Ltd.
04 1Masung LS Co., Ltd.
05 2Samoh Pharmaceutical Co., Ltd.
06 1Shin Poong Pharmaceutical Co., Ltd.
01 7Temozolomide
01 1Germany
02 4India
03 1Taiwan
04 1U.S.A
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 207-56-ND
Manufacturer Name : Excella GmbH & Co. KG
Manufacturer Address : Nurnberger Strasse 12, 90537 Feucht, Germany
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2005-03-16
Registration Number : 406-1-ND
Manufacturer Name : Ampac Fine Chemicals
Manufacturer Address : Highway 50 & Hazel Avenue, Rancho Cordova, CA, USA
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2015-08-11
Registration Number : Number 1367-1-ND
Manufacturer Name : Formosa Laboratories, Inc. L...
Manufacturer Address : No. 36 & 36-1 Hoping Street, Louchu Country, Taoyuan 33842, Taiwan@Norland Shizhuang ...
Registrant Name : Shin Poong Pharmaceutical Co., Ltd.
Registration Date : 2013-01-15
Registration Number : 1414-4-ND
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Are...
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2013-05-15
Registration Number : 1414-4-ND(A)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No.: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Ar...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2013-07-26
Registration Number : 1414-4-ND(2)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No.: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Ar...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2016-07-13
Registration Number : 207-27-ND
Manufacturer Name : Sun Pharmaceutical Industrie...
Manufacturer Address : A-7/A-8, MIDC, Industrial Area, Ahmednagar-414 111. Maharashtra State, India
A Temozolomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temozolomide, including repackagers and relabelers. The FDA regulates Temozolomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temozolomide 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 Temozolomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temozolomide supplier is an individual or a company that provides Temozolomide active pharmaceutical ingredient (API) or Temozolomide finished formulations upon request. The Temozolomide suppliers may include Temozolomide API manufacturers, exporters, distributors and traders.
click here to find a list of Temozolomide 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 Temozolomide Drug Master File in Korea (Temozolomide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Temozolomide. The MFDS reviews the Temozolomide KDMF as part of the drug registration process and uses the information provided in the Temozolomide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Temozolomide 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 Temozolomide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Temozolomide suppliers with KDMF on PharmaCompass.
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