01 1Alembic Pharmaceuticals Limited
02 1Beijing Sjar Technology Development
03 1Olon S.p.A
04 1Shanghai Hope Chem
01 2China
02 1India
03 1Italy
01 2Active
02 2Blank
01 4Blank
01 4Blank
01 4Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-11
Pay. Date : 2022-05-05
DMF Number : 37066
Submission : 2022-05-27
Status : Active
Type : II
NDC Package Code : 17337-0316
Start Marketing Date : 2022-06-08
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 : 36785
Submission : 2022-03-31
Status : Active
Type : II
A Larotrectinib Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Larotrectinib Sulfate, including repackagers and relabelers. The FDA regulates Larotrectinib Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Larotrectinib Sulfate 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 Larotrectinib Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Larotrectinib Sulfate supplier is an individual or a company that provides Larotrectinib Sulfate active pharmaceutical ingredient (API) or Larotrectinib Sulfate finished formulations upon request. The Larotrectinib Sulfate suppliers may include Larotrectinib Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Larotrectinib Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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