Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Dasami Lab
01 1SUVOREXANT
02 1SUVOREXANT (FORM-II)
01 2India
01 2Active
01 1Complete
02 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40216
Submission : 2024-08-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-27
Pay. Date : 2023-10-26
DMF Number : 38929
Submission : 2023-10-25
Status : Active
Type : II
A Suvorexant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suvorexant, including repackagers and relabelers. The FDA regulates Suvorexant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suvorexant 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 Suvorexant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Suvorexant supplier is an individual or a company that provides Suvorexant active pharmaceutical ingredient (API) or Suvorexant finished formulations upon request. The Suvorexant suppliers may include Suvorexant API manufacturers, exporters, distributors and traders.
click here to find a list of Suvorexant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Suvorexant DMF (Drug Master File) is a document detailing the whole manufacturing process of Suvorexant active pharmaceutical ingredient (API) in detail. Different forms of Suvorexant DMFs exist exist since differing nations have different regulations, such as Suvorexant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Suvorexant DMF submitted to regulatory agencies in the US is known as a USDMF. Suvorexant USDMF includes data on Suvorexant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Suvorexant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Suvorexant suppliers with USDMF on PharmaCompass.
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