01 1Carbogen Amcis AG
02 1Hetero Labs Limited(Unit-I)
03 1Lonza Ltd.
04 2MSN Laboratories Private Limited
05 1Synthon, sro
01 1Aging Life Science Co., Ltd.
02 2Korea BMS Pharmaceutical Co., Ltd.
03 1Kukjeon Pharmaceutical Co., Ltd.
04 1Kwangdong Pharmaceutical Co., Ltd.
05 1Lee Sung International Co., Ltd.
01 6Pomalidomide
01 3India
02 1Netherlands
03 1Switzerland
04 1U.S.A
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2017-03-08
Registration Number : 17-7-ND
Manufacturer Name : Carbogen Amcis AG
Manufacturer Address : Hauptstrasse 171, CH-4416 Bubendorf, Switzerland
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2020-10-15
Registration Number : Thu21-16-ND
Manufacturer Name : Hetero Labs Limited(Unit-I)
Manufacturer Address : Sy. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangan...
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2017-03-08
Registration Number : 17-6-ND
Manufacturer Name : Lonza Ltd.
Manufacturer Address : Chemie, Lonzastrasse, 3930 Visp, Switzerland
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-11-24
Registration Number : 434-43-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-05-19
Registration Number : 434-43-ND(1)
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Kwangdong Pharmaceutical Co., Ltd.
Registration Date : 2022-12-05
Registration Number : Su0150-2-ND
Manufacturer Name : Synthon, sro
Manufacturer Address : Brněnská 32/čp.597, Blansko 678 01, Czech Republic
A Pomalyst manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pomalyst, including repackagers and relabelers. The FDA regulates Pomalyst manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pomalyst 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 Pomalyst manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pomalyst supplier is an individual or a company that provides Pomalyst active pharmaceutical ingredient (API) or Pomalyst finished formulations upon request. The Pomalyst suppliers may include Pomalyst API manufacturers, exporters, distributors and traders.
click here to find a list of Pomalyst 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 Pomalyst Drug Master File in Korea (Pomalyst KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pomalyst. The MFDS reviews the Pomalyst KDMF as part of the drug registration process and uses the information provided in the Pomalyst KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pomalyst 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 Pomalyst API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pomalyst suppliers with KDMF on PharmaCompass.
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