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Drafts of revised USP plastic packaging chapters and : removal of the...
DRUG REGULATORY AFFAIRS INTERNATIONAL In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the...
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EDQM announces revision of general chapter Monocyte Activation Test (2.6.30)
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TOFOGLIFLOZIN 托格列净
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Lobeglitazone sulfate (Duvie)
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AZD 3514 MALEATE
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AZD 1981
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Pidotimod, 匹多莫德 , пидотимод , بيدوتيمود ,
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Delamanid, (Deltyba) デラマニド
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Prucalopride succinate (Resolor)
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WHO Draft on Analytical Method Validation
DRUG REGULATORY AFFAIRS INTERNATIONAL The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft “Guidelines on...
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MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft...
DRUG REGULATORY AFFAIRS INTERNATIONAL In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a “GMP Data Integrity Definitions and Guidance for...
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Written Confirmation expired: Can an API still be imported when produced...
DRUG REGULATORY AFFAIRS INTERNATIONAL What needs to be considered if an API is produced in the time period of a valid written confirmation but imported after this confirmation has expired? This is...
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Varenicline (Chantix™) バレニクリン酒石酸塩
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Biafungin, CD 101, a Novel Echinocandin for Vulvovaginal candidiasis
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GSK-2041706A, Potent GPR119 Receptor Agonists
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FDA published generic user fee for 2017: for ANDA, DMF, and for Facility...
DRUG REGULATORY AFFAIRS INTERNATIONAL . http://www.raps.org/Regulatory-Focus/News/2016/07/26/25394/FDA-Lowers-ANDA-Fee-Rates-for-2017/ Generic drugmakers submitting abbreviated new drug applications...
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Lovastatin
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MICONAZOLE NITRATE , Миконазол , ミコナゾール硝酸塩
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