01 1SMS Pharmaceuticals
01 1PENCICLOVIR
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29724
Submission : 2015-09-02
Status : Active
Type : II
A Penciclovir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penciclovir Sodium, including repackagers and relabelers. The FDA regulates Penciclovir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penciclovir Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Penciclovir Sodium supplier is an individual or a company that provides Penciclovir Sodium active pharmaceutical ingredient (API) or Penciclovir Sodium finished formulations upon request. The Penciclovir Sodium suppliers may include Penciclovir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Penciclovir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Penciclovir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Penciclovir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Penciclovir Sodium DMFs exist exist since differing nations have different regulations, such as Penciclovir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Penciclovir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Penciclovir Sodium USDMF includes data on Penciclovir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Penciclovir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Penciclovir Sodium suppliers with USDMF on PharmaCompass.
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