ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1API Pharma
03 1Alembic Pharmaceuticals Limited
04 1Charioteer
05 1Maithri Drugs
06 1Torrent Pharmaceuticals Limited
07 1Viatris
01 6PENCICLOVIR
02 1PENCICLOVIR (API)
01 1China
02 1Croatia
03 3India
04 2U.S.A
01 6Active
02 1Inactive
01 6Complete
02 1Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-07
Pay. Date : 2018-11-06
DMF Number : 33260
Submission : 2018-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-12
Pay. Date : 2020-09-29
DMF Number : 35032
Submission : 2020-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-19
Pay. Date : 2020-01-13
DMF Number : 34514
Submission : 2020-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-30
Pay. Date : 2016-08-05
DMF Number : 30758
Submission : 2016-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-19
Pay. Date : 2022-05-31
DMF Number : 35243
Submission : 2020-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-10-28
DMF Number : 36410
Submission : 2021-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34375
Submission : 2019-12-19
Status : Inactive
Type : II
A Penciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penciclovir, including repackagers and relabelers. The FDA regulates Penciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penciclovir 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 Penciclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penciclovir supplier is an individual or a company that provides Penciclovir active pharmaceutical ingredient (API) or Penciclovir finished formulations upon request. The Penciclovir suppliers may include Penciclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Penciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penciclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Penciclovir active pharmaceutical ingredient (API) in detail. Different forms of Penciclovir DMFs exist exist since differing nations have different regulations, such as Penciclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Penciclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Penciclovir USDMF includes data on Penciclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Penciclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Penciclovir suppliers with USDMF on PharmaCompass.
We have 7 companies offering Penciclovir
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