01 1Dynamit Nobel GmbH
01 1Encomac Co., Ltd.
01 1nitroglycerin
01 1Germany
Registrant Name : Encomac Co., Ltd.
Registration Date : 2021-11-10
Registration Number : 20211110-210-J-1146
Manufacturer Name : Dynamit Nobel GmbH
Manufacturer Address : D-51377, Kalkstrasse 218 Leverkusen, Germany
38
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A Nitropatch manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitropatch, including repackagers and relabelers. The FDA regulates Nitropatch manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitropatch 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 Nitropatch manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nitropatch supplier is an individual or a company that provides Nitropatch active pharmaceutical ingredient (API) or Nitropatch finished formulations upon request. The Nitropatch suppliers may include Nitropatch API manufacturers, exporters, distributors and traders.
click here to find a list of Nitropatch suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Nitropatch Drug Master File in Korea (Nitropatch KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitropatch. The MFDS reviews the Nitropatch KDMF as part of the drug registration process and uses the information provided in the Nitropatch KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitropatch 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 Nitropatch API can apply through the Korea Drug Master File (KDMF).
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