Warmly celebrate our company´s application for new drug "olanzapine" to obtain the "API registration number" issued by the state
Release Time: 2019-01-11 16:36:24 Visited: 5230 times
In 2012, our company applied to the State Food and Drug Administration for "olanzapine", a new drug for schizophrenia. After the review of the drug evaluation center of the State Food and Drug Administration and the supplementary research of the company's R & D department, we finally obtained the "registration number of raw material drug: y20170001881" in 2017. Information inquiry way: log in the website of drug evaluation center of State Food and drug administration http://www.cde.org.cn/ Hot column (grade information publicity of API, pharmaceutical excipients and drug packaging materials) → API query → enter enterprise name column (Henan Jingkang Pharmaceutical Co., Ltd.) → click query) "
Warmly celebrate our company's four APIs successfully passed the registration on-site verification and GMP certification on-site inspection
In February 2018, our company passed the registration on-site verification and GMP certification on the four products of "potassium dihydrogen phosphate, potassium dihydrogen phosphate, lansoprazole and Difenidol hydrochloride". This is the GMP certification on-site inspection that our company passed again after the raw materials lomefloxacin aspartate and sparshacin passed the GMP certification.
Product display, API:
Existing varieties: lomefloxacin aspartate, add "Approval Number: Guoyao Zhunzi h20010287"
CAS No.: 211690-3-4
Sparfloxacin added "Approval Number: Guoyao Zhunzi h10980096"
CAS No.: 110871-86-8
The following new varieties were added: olanzapine, potassium dihydrogen phosphate, potassium dihydrogen phosphate, lansoprazole and Difenidol hydrochloride
Olanzapine (API registration number: y20170001881)
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Common name: olanzapine
CAS No.: 132539-06-1
Structural formula, molecular formula and molecular weight
Molecular formula: c17h20n4s
Molecular weight: 312.43
Properties: yellow crystalline powder. This product is slightly soluble in acetone or chloroform, slightly soluble in methanol, almost insoluble in water.
Category: antipsychotics.
Quality standard: ministry standard
Package specification: 1kg / barrel, 5kg / barrel
Lansoprazole
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Common name: Lansoprazole
CAS No.: 103577-45-3
Structural formula, molecular formula and molecular weight
Molecular formula: c16h14f3n3o2s
Molecular weight: 369.37
Properties: This product is white or almost white crystalline powder; odorless, easy to deteriorate in light and air.
Category: proton pump inhibitors
Quality standard: Chinese Pharmacopoeia (Volume 2, 2015 Edition)
Package specification: 5kg / bag
Difenidol hydrochloride
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Common name: Difenidol hydrochloride
CAS No.: 3254-89-5
Structural formula, molecular formula and molecular weight
Molecular formula: C21H27NO · HCl
Molecular weight: 345.91
Properties: white crystalline powder, odorless.
Category: antiemetic drugs.
Quality standard: Chinese Pharmacopoeia (Volume 2, 2015 Edition)
Package size: 15kg / bag
Potassium dihydrogen phosphate
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Common name: potassium dihydrogen phosphate
CAS No. 7778-77-0
Structural formula, molecular formula and molecular weight
Molecular formula: KH2PO4
Molecular weight: 136.09
Properties: This product is colorless crystalline or white crystalline powder or particle or block, odorless. This product is easily soluble in water and almost insoluble in ethanol.
Category: pH regulator, phosphorus supplement.
Quality standard: ministry standard
Package specification: 25kg / barrel
Dipotassium hydrogen phosphate
Common name: dipotassium hydrogen phosphate
CAS No. 16788-57-1
Structural formula, molecular formula and molecular weight
Molecular formula: K2HPO4 · 3H2O
Molecular weight: 228.22
Properties: colorless crystal or white crystalline powder; odorless, salty and astringent; easy to deliquescence. It is soluble in water and slightly soluble in ethanol.
Category: phosphorus supplement.
Quality standard: ministry standard
Package specification: 25kg / barrel
