01 1Fujifilm holding
02 1Sandoz B2B
03 2Blank
01 1L(-)-POLYLACTIC ACID FOR USE IN DRUG DOSAGE FORMS
02 1LACTIC ACID 88% USP AND LACTIC ACID 88% LOW AMMONIA
03 1LACTIC ACID, BULK FORM
04 1POLYLACTIC ACID (PLA)
01 1Japan
02 1Switzerland
03 2Blank
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11133
Submission : 1994-10-07
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5022
Submission : 1983-03-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6700
Submission : 1986-11-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5231
Submission : 1984-02-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Lactic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactic Acid, including repackagers and relabelers. The FDA regulates Lactic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactic Acid 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 Lactic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactic Acid supplier is an individual or a company that provides Lactic Acid active pharmaceutical ingredient (API) or Lactic Acid finished formulations upon request. The Lactic Acid suppliers may include Lactic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Lactic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactic Acid active pharmaceutical ingredient (API) in detail. Different forms of Lactic Acid DMFs exist exist since differing nations have different regulations, such as Lactic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Lactic Acid USDMF includes data on Lactic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactic Acid suppliers with USDMF on PharmaCompass.
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