01 3PolyPeptide Laboratories PVT. LTD.
01 1Hanwha Pharmaceutical Co., Ltd.
02 1Korea BMI Co., Ltd.
03 1Leaders Bio Co., Ltd.
01 3Somatostatin acetate
01 3Switzerland
Registrant Name : Hanwha Pharmaceutical Co., Ltd.
Registration Date : 2017-10-30
Registration Number : 20171030-90-E-135-03
Manufacturer Name : PolyPeptide Laboratories PVT...
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar, Ambernath(E) Thane 421506, Maharashtra Stat...
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2022-09-28
Registration Number : 20171030-90-E-135-03(A)
Manufacturer Name : PolyPeptide Laboratories PVT...
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar, Ambernath(E) Thane 421506, Maharashtra Stat...
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2017-12-08
Registration Number : 20171030-90-E-135-03(1)
Manufacturer Name : PolyPeptide Laboratories PVT...
Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar, Ambernath(E) Thane 421506, Maharashtra Stat...
A Somatostatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatostatin, including repackagers and relabelers. The FDA regulates Somatostatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatostatin 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 Somatostatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Somatostatin supplier is an individual or a company that provides Somatostatin active pharmaceutical ingredient (API) or Somatostatin finished formulations upon request. The Somatostatin suppliers may include Somatostatin API manufacturers, exporters, distributors and traders.
click here to find a list of Somatostatin 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 Somatostatin Drug Master File in Korea (Somatostatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Somatostatin. The MFDS reviews the Somatostatin KDMF as part of the drug registration process and uses the information provided in the Somatostatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Somatostatin 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 Somatostatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Somatostatin suppliers with KDMF on PharmaCompass.
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