Axplora- The partner of choice for complex APIs.
01 2PharmaZell (India) Private Ltd
02 3PharmaZell GmbH
03 1Cambrex, Karlskoga AB
04 1Chemi SpA
05 1Divi`s Laboratories Limited
06 1Mylan Laboratories Limited (Unit-8)
07 1Syntese A/S
Axplora- The partner of choice for complex APIs.
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2021-10-05
Registration Number : 20210521-209-J-766(1)
Manufacturer Name : PharmaZell (India) Private L...
Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531019 Andhra...
Axplora- The partner of choice for complex APIs.
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-06-02
Registration Number : 20200602-209-J-386
Manufacturer Name : PharmaZell GmbH
Manufacturer Address : Rosenheimer Straße 43 83064 Raubling Germany
Axplora- The partner of choice for complex APIs.
Registrant Name : Korea Takeda Pharmaceutical Co., Ltd.
Registration Date : 2020-07-23
Registration Number : 20200602-209-J-386(2)
Manufacturer Name : PharmaZell GmbH
Manufacturer Address : Rosenheimer Straße 43 83064 Raubling Germany
Axplora- The partner of choice for complex APIs.
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2021-05-21
Registration Number : 20210521-209-J-766
Manufacturer Name : PharmaZell (India) Private L...
Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531019 Andhra...
Axplora- The partner of choice for complex APIs.
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2020-07-09
Registration Number : 20200602-209-J-386(1)
Manufacturer Name : PharmaZell GmbH
Manufacturer Address : Rosenheimer Straße 43 83064 Raubling Germany
A Mesalamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mesalamine, including repackagers and relabelers. The FDA regulates Mesalamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mesalamine 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 Mesalamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mesalamine supplier is an individual or a company that provides Mesalamine active pharmaceutical ingredient (API) or Mesalamine finished formulations upon request. The Mesalamine suppliers may include Mesalamine API manufacturers, exporters, distributors and traders.
click here to find a list of Mesalamine 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 Mesalamine Drug Master File in Korea (Mesalamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mesalamine. The MFDS reviews the Mesalamine KDMF as part of the drug registration process and uses the information provided in the Mesalamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mesalamine 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 Mesalamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mesalamine suppliers with KDMF on PharmaCompass.
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