Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
01 1Fareva
02 1Fidia Farmaceutici Spa
03 1Hainan Poly Pharm
04 1Rajasthan Antibiotics
05 1Solara Active Pharma Sciences
06 1Sterile India Pvt. Ltd
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2013-09-26
DMF Number : 10945
Submission : 1994-06-09
Status :
Type : II
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A sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate, including repackagers and relabelers. The FDA regulates sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate supplier is an individual or a company that provides sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate active pharmaceutical ingredient (API) or sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate finished formulations upon request. The sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate suppliers may include sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate API manufacturers, exporters, distributors and traders.
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A sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate DMF (Drug Master File) is a document detailing the whole manufacturing process of sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate active pharmaceutical ingredient (API) in detail. Different forms of sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate DMFs exist exist since differing nations have different regulations, such as sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate DMF submitted to regulatory agencies in the US is known as a USDMF. sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate USDMF includes data on sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 6 companies offering sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate
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