DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories Limited
02 1Cilag AG
03 1Shilpa Pharma Lifesciences Limited
04 1Shilpa Pharma Lifesciences Limited (unit-2)
01 1Boryeong Co., Ltd.
02 1Korea Janssen Co., Ltd.
03 1Masung LS Co., Ltd.
04 1Pami Future Co., Ltd.
05 1Samyang Holdings Co., Ltd.
01 5Decitabine
01 4India
02 1Switzerland
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2024-08-09
Registration Number : No. 574-25-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTO-Unit I, Plot No. 137, 138, 145 & 146, Sri Venkateswara Co-operative industrial es...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-05-16
Registration Number : Su249-3-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : Chemical Technical Operations Unit-Ⅵ, APⅡC Industrial Estate, Pydibhimavaram, Ran...
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2014-04-10
Registration Number : No. 4945-17-ND
Manufacturer Name : Cilag AG
Manufacturer Address : Hochstrasse 201, 8200 Schaffhausen, Swirzerland
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2017-08-03
Registration Number : Number 163-13-ND
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 23 Seocho-daero 51-gil, Seocho-gu, Seoul, Seojong Building @Plot No. 33, 33A, 40 to 4...
Registrant Name : Samyang Holdings Co., Ltd.
Registration Date : 2018-06-25
Registration Number : No. 163-13-ND(1)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No.33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Ch...
A Decitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Decitabine, including repackagers and relabelers. The FDA regulates Decitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Decitabine 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 Decitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Decitabine supplier is an individual or a company that provides Decitabine active pharmaceutical ingredient (API) or Decitabine finished formulations upon request. The Decitabine suppliers may include Decitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Decitabine 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 Decitabine Drug Master File in Korea (Decitabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Decitabine. The MFDS reviews the Decitabine KDMF as part of the drug registration process and uses the information provided in the Decitabine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Decitabine 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 Decitabine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Decitabine suppliers with KDMF on PharmaCompass.
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