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Indian Generics 2016
The generic APIs market is expected to continue to rise faster than the branded/innovative APIs, by 7.7%/year to reach $30.3 billion in 2016. Asia-Pacific is expected to show the fastest growth rates...
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ENZALUTAMIDE
Enzalutamide, MDV-3100 MDV3100 is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. MDV3100 (Enzalutamide)...
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MORINIDAZOLE
MORINIDAZOLE 1- [3- (4-morpholinyl) -2-hydroxypropyl] -2-methyl-5- nitro -1H- imidazole CAS 92478-27-8 Jiangsu Hansoh Pharmaceutical Co., Ltd. Morinidazole was approved by China Food and Drug...
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MIRABEGRON
MIRABEGRON Betanis Myrbetriq UNII-MVR3JL3B2V YM 178 YM178 Мирабегрон ميرابيغرون 米拉贝隆 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide MF: C21H24N4O2S...
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Indian and Chinese API Manufacturers in the Focus of European Authorities
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Indian and Chinese API Manufacturers in the Focus of European Authorities The EudraGMP database was originally launched in April 2007...
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Updating of the HMPC-Guideline on the use of the CTD Format in the...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products Compared to herbal...
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Sacubitril
Sacubitril, AHU 377 4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoic acid 5-(Biphenyl-4-yl)-4(S)-(3-carboxypropionamido)-2(R)-methylbutyric acid ethyl ester...
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SD-809, Deutetrabenazine NDA Submitted by TEVA
SD-809 (deutetrabenazine) (3RS,11Brs)-9,10-di((2H3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-one 2H-Benzo(a)quinolizin-2-one,...
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Orilotimod
Orilotimod (2R)-2-amino-5-{[(1R)-1-carboxy-2-(1H-indol-3-yl)ethyl]amino}-5-oxopentanoic acid 186087-26-3 Apo805,UNII-Q66Z43C5XM; Thymodepressin; Orilotimod [USAN]; AC1OIBUF; C16H19N3O5 MW 333.339...
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Filgotinib
Filgotinib C21H23N5O3S MW425.504 Elemental Analysis: C, 59.28; H, 5.45; N, 16.46; O, 11.28; S, 7.54 1206161-97-8 Cyclopropanecarboxamide,...
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FDA approves flibanserin first treatment for sexual desire disorder
FDA approves first treatment for sexual desire disorder Addyi approved to treat premenopausal women SEE FULL SYNTHESIS …CLICK HERE The U.S. Food and Drug Administration today approved to treat...
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Gamendazole a novel drug candidate for male contraception.
Gamendazole (E) 3-(1-(2,4-Dichlorobenzyl)-6-(trifluoromethyl)-1H-indazol-3-yl)acrylic Acid trans-3-(1-Benzyl-6-(trifluoromethyl)-1H-indazol-3-yl)acrylic acid)...
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Lusutrombopag….Oral thrombopoietin (TPO) mimetic
Lusutrombopag (E)-3-[2,6-dichloro-4-[[4-[3-[(1S)-1-hexoxyethyl]-2-methoxyphenyl]-1,3-thiazol-2-yl]carbamoyl]phenyl]-2-methylprop-2-enoic acid...
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Avatrombopag
Avatrombopag AVATROMBOPAG; UNII-3H8GSZ4SQL; AKR-501; E5501; 570406-98-3; AS 1670542 C29H34Cl2N6O3S2 Molecular Weight: 649.65466 g/mol Elemental Analysis: C, 53.61; H, 5.28; Cl, 10.91; N, 12.94; O,...
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ASLAN Pharmaceuticals Gains Orphan Designation for Rare Cancer Drug ASLAN001...
(R)-N4-[3-Chloro-4-(thiazol-2-ylmethoxy)-phenyl]-N6-(4-methyl-4,5-dihydro-oxazol-2-yl)-quinazoline-4,6-diamine ASLAN001 , Varlitinib C22H19ClN6O2S Molecular Weight: 466.94 Elemental Analysis: C,...
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Bempedoic Acid
Bempedoic Acid ETC-1002, ESP-55016 CAS 738606-46-7 C19H36O5 MW 344.486 Da 8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid 8-Hydroxy-2.2.14,14-tetramethylpentadecanedioic acid ATP Citrate Lyase...
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FDA warns Mylan about cGMP violations at its Indian facilities
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The US FDA has warned Mylan about manufacturing concerns at three of its plants in India. In a warning letter to the generic drug...
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AN IMPROVED PROCESS FOR THE PREPARATION OF DOLUTEGRAVIR
Aurobindo Pharma MD and CEO N. Govindarajan at a company research centre. “It [the transition] is purely driven by the need to get more into areas where there is scope for better profit margins,...
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Pevonedistat
Millennium Pharmaceuticals, Inc. INNOVATOR Millennium Pharmaceuticals, Inc., a subsidiary of Takeda Pharmaceutical Company Limited, MLN4924, MLN 4924-003, TAK-924 905579-51-3 BASE 1160295-21-5 HcL A...
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Non compliance at Parabolic drugs
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Statement “non compliance GMP”. Officina Farmaceutica: Parabolic Drugs Limited – INDIA (30/07/2015)...
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