Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Chattem Chemicals, Inc
03 1Mallinckrodt Pharmaceuticals
04 2Tris Pharma Inc
01 2METHYLPHENIDATE BASE
02 1METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)
03 1METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)
04 1METHYLPHENIDATE FREE BASE
01 1Ireland
02 4U.S.A
01 5Active
01 1Complete
02 4Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22939
Submission : 2009-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17668
Submission : 2004-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-17
Pay. Date : 2013-02-26
DMF Number : 13132
Submission : 1998-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25909
Submission : 2012-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23870
Submission : 2010-07-20
Status : Active
Type : II
A Methylphenidate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylphenidate, including repackagers and relabelers. The FDA regulates Methylphenidate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylphenidate 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 Methylphenidate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylphenidate supplier is an individual or a company that provides Methylphenidate active pharmaceutical ingredient (API) or Methylphenidate finished formulations upon request. The Methylphenidate suppliers may include Methylphenidate API manufacturers, exporters, distributors and traders.
click here to find a list of Methylphenidate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylphenidate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylphenidate active pharmaceutical ingredient (API) in detail. Different forms of Methylphenidate DMFs exist exist since differing nations have different regulations, such as Methylphenidate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylphenidate DMF submitted to regulatory agencies in the US is known as a USDMF. Methylphenidate USDMF includes data on Methylphenidate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylphenidate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylphenidate suppliers with USDMF on PharmaCompass.
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