DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Dasami Lab
03 1Maithri Drugs
04 1Zydus Lifesciences
01 4LUMATEPERONE TOSYLATE
01 4India
01 4Active
01 4Complete
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-21
Pay. Date : 2023-08-17
DMF Number : 38206
Submission : 2023-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-05
Pay. Date : 2023-05-17
DMF Number : 38407
Submission : 2023-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-26
Pay. Date : 2023-09-22
DMF Number : 38730
Submission : 2023-09-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-09-21
DMF Number : 38778
Submission : 2023-09-21
Status : Active
Type : II
A Lumateperone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumateperone, including repackagers and relabelers. The FDA regulates Lumateperone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumateperone 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 Lumateperone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lumateperone supplier is an individual or a company that provides Lumateperone active pharmaceutical ingredient (API) or Lumateperone finished formulations upon request. The Lumateperone suppliers may include Lumateperone API manufacturers, exporters, distributors and traders.
click here to find a list of Lumateperone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lumateperone DMF (Drug Master File) is a document detailing the whole manufacturing process of Lumateperone active pharmaceutical ingredient (API) in detail. Different forms of Lumateperone DMFs exist exist since differing nations have different regulations, such as Lumateperone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lumateperone DMF submitted to regulatory agencies in the US is known as a USDMF. Lumateperone USDMF includes data on Lumateperone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lumateperone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lumateperone suppliers with USDMF on PharmaCompass.
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