Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Aurobindo Pharma Limited
03 1GLAND PHARMA LIMITED
01 3ERYTHROMYCIN LACTOBIONATE
01 3India
01 3Active
01 3Complete
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-08
Pay. Date : 2020-09-28
DMF Number : 34750
Submission : 2020-09-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-16
Pay. Date : 2019-08-14
DMF Number : 34072
Submission : 2019-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-26
Pay. Date : 2021-04-29
DMF Number : 34426
Submission : 2019-12-31
Status : Active
Type : II
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A C37H67NO13.C12H22O12 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C37H67NO13.C12H22O12, including repackagers and relabelers. The FDA regulates C37H67NO13.C12H22O12 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 supplier is an individual or a company that provides C37H67NO13.C12H22O12 active pharmaceutical ingredient (API) or C37H67NO13.C12H22O12 finished formulations upon request. The C37H67NO13.C12H22O12 suppliers may include C37H67NO13.C12H22O12 API manufacturers, exporters, distributors and traders.
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A C37H67NO13.C12H22O12 DMF (Drug Master File) is a document detailing the whole manufacturing process of C37H67NO13.C12H22O12 active pharmaceutical ingredient (API) in detail. Different forms of C37H67NO13.C12H22O12 DMFs exist exist since differing nations have different regulations, such as C37H67NO13.C12H22O12 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C37H67NO13.C12H22O12 DMF submitted to regulatory agencies in the US is known as a USDMF. C37H67NO13.C12H22O12 USDMF includes data on C37H67NO13.C12H22O12's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C37H67NO13.C12H22O12 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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