Category Archives: Uncategorized

The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients

Originally posted on New Drug Approvals:
The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable.…

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Finally published: new Annex 16 on QP Certification and Batch Release

Originally posted on New Drug Approvals:
? Finally published: new Annex 16 on QP Certification and Batch Release The European Commission finally has published the new EU-GMP Guideline Annex 16 “Certification by a Qualified Person and Batch Release“. The European…

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INDA

Originally posted on Dr. Charmy Kothari:
Source: INDA

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DRUG COMPANIES

Originally posted on Dr. Charmy Kothari:
Source: DRUG COMPANIES

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BMS-248360, A NEW SARTAN ON HORIZON

Originally posted on New Drug Approvals:
2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-[(3,3-dimethyl-2-oxopyrrolidin-1-yl)methyl]phenyl]-N-(3,4-dimethyl-1,2-oxazol-5-yl)benzenesulfonamide 4‘-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(3,4-dimethyl-5-isoxazolyl)-2‘-[(3,3-dimethyl-2-oxo-1-pyrrolidinyl)methyl]-[1,1‘-biphenyl]-2-sulfonamide, 4′- . (2-Butyl-4-oxo- 1 ,3-diazaspiro [4.41 non-l-en-3-yl)methyll -N-C3.4- dimethyl-5-isoxazolyl)-2,-[(3.3-dimethyl-2-oxo-l- pyrrolidinvDmethyll [1.1 ‘-biphenyl] -2-sulfonamide 4‘-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N–(3,4-dimethyl-5-isoxazolyl)-2‘-[(3,3-dimethyl-2-oxo-1-pyrrolidinyl)methyl]-[1,1‘-biphenyl]-2-sulfonamide BMS-248360 PRECLINICAL …..treating hypertension Bristol Myers Squibb Co, INNOVATOR Hypertension remains one of the largest unmet medical needs…

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Invitation for National Seminar on CTD: Technical and Regulatory Requirement on 26th September, 2015

Dear All, Greetings from Institute of Pharmacy, Nirma University. It is the matter of great pleasure for us to invite you for National Seminar on “CTD: Technical & Regulatory Requirement” conducted by Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma … Continue reading

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Dear studetns, Welcome to Pharma Regulatory FIeld

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