01 1Beckman Coulter
02 1Merck Serono
03 1Peninsula Laboratories
04 2SIGMA TAU
05 3Blank
01 1BIOACTIVE PEPTIDES (FORMERLY SOMATOSTATIN)
02 2SOMATOSTATIN
03 1SOMATOSTATIN (OVINE)
04 1SOMATOSTATIN (PRODUCT NO. S 9129 FD)
05 1SOMATOSTATIN ACETATE HYDRATE (CM 9357)
06 1STILAMIN (SOMATOSTIN)
07 1SYNTHETIC SOMATOSTATIN AS SYNTHESIZED IN BELMONT, CA. FACILITIES
01 1Germany
02 4U.S.A
03 3Blank
01 1Active
02 7Inactive
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3431
Submission : 1978-12-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4579
Submission : 1982-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5128
Submission : 1983-11-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10188
Submission : 1993-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4492
Submission : 1982-04-06
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39985
Submission : 2024-05-29
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5481
Submission : 1984-07-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3944
Submission : 1980-07-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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.
A Somatostatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Somatostatin active pharmaceutical ingredient (API) in detail. Different forms of Somatostatin DMFs exist exist since differing nations have different regulations, such as Somatostatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Somatostatin DMF submitted to regulatory agencies in the US is known as a USDMF. Somatostatin USDMF includes data on Somatostatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Somatostatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Somatostatin suppliers with USDMF on PharmaCompass.
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