01 2Symed Labs Limited (Unit II)
02 1Tyche Industries Limited
01 2Aging Life Science Co., Ltd.
02 1IMCD Korea Co., Ltd.
01 3lacecadotril
01 3India
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2021-07-15
Registration Number : 20210715-211-J-886
Manufacturer Name : Symed Labs Limited (Unit II)
Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri Distri...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-11-22
Registration Number : 20210715-211-J-886(A)
Manufacturer Name : Symed Labs Limited (Unit II)
Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri Distri...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-211-J-692
Manufacturer Name : Tyche Industries Limited
Manufacturer Address : D.No. 6-223, Sarpavaram, Kakinada, East Godavari District, Andhra Pradesh, India
A Racecadotril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Racecadotril, including repackagers and relabelers. The FDA regulates Racecadotril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Racecadotril 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 Racecadotril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Racecadotril supplier is an individual or a company that provides Racecadotril active pharmaceutical ingredient (API) or Racecadotril finished formulations upon request. The Racecadotril suppliers may include Racecadotril API manufacturers, exporters, distributors and traders.
click here to find a list of Racecadotril 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 Racecadotril Drug Master File in Korea (Racecadotril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Racecadotril. The MFDS reviews the Racecadotril KDMF as part of the drug registration process and uses the information provided in the Racecadotril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Racecadotril 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 Racecadotril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Racecadotril suppliers with KDMF on PharmaCompass.
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