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MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft...
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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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FDA approves Adlyxin (lixisenatide) to treat type 2 diabetes
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VELPATASVIR (GS-5816), GILEAD SCIENCES, велпатасвир, فالباتاسفير , 维帕他韦 ,
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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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ацетазоламид , أسيتازولاميد [, 乙酰唑胺 , ACETAZOLAMIDE
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Gemfibrozil
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Scaling up from mg to Kgs – Making your First GMP Batch
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FDA published generic user fee for 2017: for ANDA, DMF, and for Facility...
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Arformoterol, (R,R)-Formoterol For Chronic obstructive pulmonary disease (COPD)
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APIC is working on an enhanced ICH Q7 How to do Guide
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New WHO guidance on variations to multisource pharmaceutical products
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Eribulin, エリブリンメシル酸塩 an Antineoplastic
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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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