ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Transo-Pharm USA LLC
03 1Chongqing Sintaho Pharmaceutical
04 1Shanghai Minbiotech
05 1Apicore LLC
06 1Aurore Life Sciences
07 1BrightGene Bio-Medical Technology Co.,Ltd
08 1MSN Laboratories
09 1Natco Pharma
10 1PharmaMar
11 1Shenzhen Haorui
12 1Wisdom Pharmaceutical
13 1Xiling Lab
01 6China
02 4India
03 1Spain
04 2U.S.A
01 7Active
02 6Blank
01 13Blank
01 13Blank
01 13Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
NDC Package Code : 54893-0508
Start Marketing Date : 2024-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39620
Submission : 2024-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
A Lurbinectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurbinectedin, including repackagers and relabelers. The FDA regulates Lurbinectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurbinectedin 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 Lurbinectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurbinectedin supplier is an individual or a company that provides Lurbinectedin active pharmaceutical ingredient (API) or Lurbinectedin finished formulations upon request. The Lurbinectedin suppliers may include Lurbinectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Lurbinectedin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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