Veranova: A CDMO that manages complexity with confidence.
01 2Veranova
02 1Noramco
03 2Alkem Laboratories
04 1Cambrex Corporation
05 1Chattem Chemicals, Inc
06 1DMFs Not Supported
07 2Mallinckrodt Pharmaceuticals
01 1Bis-Boc-Lisdexamfetamine
02 5LISDEXAMFETAMINE DIMESYLATE
03 1LISDEXAMFETAMINE DIMESYLATE B1625
04 1LISDEXAMFETAMINE DIMESYLATE DRUG SUBSTANCE
05 1LISDEXAMFETAMINE DIMESYLATE INT
06 1MMB4 DIMESYLATE
01 2India
02 2Ireland
03 5U.S.A
04 1Blank
01 8Active
02 2Inactive
01 5Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38667
Submission : 2023-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36325
Submission : 2021-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20103
Submission : 2006-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-02
Pay. Date : 2018-05-22
DMF Number : 32289
Submission : 2018-05-18
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35754
Submission : 2021-05-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-28
Pay. Date : 2020-06-03
DMF Number : 34823
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32210
Submission : 2017-11-22
Status : Inactive
Type : II
A Lisdexamfetamine Dimesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lisdexamfetamine Dimesylate, including repackagers and relabelers. The FDA regulates Lisdexamfetamine Dimesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lisdexamfetamine Dimesylate supplier is an individual or a company that provides Lisdexamfetamine Dimesylate active pharmaceutical ingredient (API) or Lisdexamfetamine Dimesylate finished formulations upon request. The Lisdexamfetamine Dimesylate suppliers may include Lisdexamfetamine Dimesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Lisdexamfetamine Dimesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lisdexamfetamine Dimesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lisdexamfetamine Dimesylate active pharmaceutical ingredient (API) in detail. Different forms of Lisdexamfetamine Dimesylate DMFs exist exist since differing nations have different regulations, such as Lisdexamfetamine Dimesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lisdexamfetamine Dimesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Lisdexamfetamine Dimesylate USDMF includes data on Lisdexamfetamine Dimesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lisdexamfetamine Dimesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lisdexamfetamine Dimesylate suppliers with USDMF on PharmaCompass.
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