01 1Alkem Laboratories
02 1Aurobindo Pharma Limited
03 1Glenmark Life Sciences
04 1Hetero Drugs
05 1Hikma Pharmaceuticals
06 1Unichem Laboratories Limited
01 5SOLRIAMFETOL HYDROCHLORIDE
02 1Solriamfetol Hydrochloride
01 5India
02 1United Kingdom
01 6Active
01 6Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-15
Pay. Date : 2023-02-03
DMF Number : 36951
Submission : 2022-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-16
Pay. Date : 2022-11-14
DMF Number : 34741
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2023-01-25
DMF Number : 36949
Submission : 2022-03-30
Status : Active
Type : II
A Solriamfetol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solriamfetol, including repackagers and relabelers. The FDA regulates Solriamfetol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solriamfetol 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 Solriamfetol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solriamfetol supplier is an individual or a company that provides Solriamfetol active pharmaceutical ingredient (API) or Solriamfetol finished formulations upon request. The Solriamfetol suppliers may include Solriamfetol API manufacturers, exporters, distributors and traders.
click here to find a list of Solriamfetol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Solriamfetol DMF (Drug Master File) is a document detailing the whole manufacturing process of Solriamfetol active pharmaceutical ingredient (API) in detail. Different forms of Solriamfetol DMFs exist exist since differing nations have different regulations, such as Solriamfetol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solriamfetol DMF submitted to regulatory agencies in the US is known as a USDMF. Solriamfetol USDMF includes data on Solriamfetol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solriamfetol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Solriamfetol suppliers with USDMF on PharmaCompass.
We have 6 companies offering Solriamfetol
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
