GUIDANCE FOR INDUSTRY ON FIXED DOSE …

SCHEDULE M - Central Drugs Standard Control …

[SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. Note: - To achieve the objectives listed below, each licensee shall evolve appropriate

  Good, Practices, Pharmaceutical, Schedule m, Schedule, For pharmaceutical

GUIDANCE FOR INDUSTRY ON PREPARATION OF …

guidelines on common technical document (ctd) 28.10.2010 page 1 of 110 guidance for industry on preparation of common technical document for import / manufacture and marketing approval

  Document, Guidance, Technical, Preparation, Industry, Common, Guidance for industry on preparation of, Common technical document, Guidance for industry on preparation of common technical document

Ministry of Health and Family Welfare, …

1 Ministry of Health and Family Welfare, Government of India has approved 25 panels of experts of various therapeutic areas. For evaluation of various categories of applications of clinical trials, new

  Health, Family, India, Government, Welfare, Ministry, Government of india, Ministry of health and family welfare

CDSCO - Guidance for Industry

Guidance for Industry Central Drugs Standard Control Organization Page 3 OBJECTIVE This Guidance has been developed in conformity with Drugs and Cosmetics

  Guidance, Industry, Guidance for industry

No.DCG (I/Misc./2017 (68) Directorate General of …

Page 1 of 1 No.DCG (I/Misc./2017 (68) Central Drugs Standard Control Organisation Directorate General of Health Services Office of Drugs Controller General India

Central Drugs Standard Control Organization

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

Guidelines on Similar Biologic: Regulatory …

Guidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India

  Guidelines, Requirements, Regulatory, Marketing, Authorization, Biologics, Regulatory requirements for marketing authorization

FIXED DOSE COMBINATIONS APPROVED BY DCG …

FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 TILL NOVEMBER, 2014 # Name of Drug Indication Date of approval …

  Dose, Till, Combination, Approved, Fixed, Fixed dose combinations approved by dcg

DRAFT GUIDANCE ON APPROVAL OF CLINICAL …

guidelines on approval of clinical trial & new drugs effective date: page 1 of 71 draft guidance on approval of clinical trials & new drugs draft guidance

  Drug, Guidance, Clinical, Trail, Approval, Guidance on approval of clinical, New drugs, Guidance on approval of clinical trials amp new drugs

CENTRAL DRUGS STANDARD CONTROL …

central drugs standard control organisation directorate general of health services, ministry of health and family welfare government of india

  General, Standards, Control, Drug, Central, Organisation, Directorate, Central drugs standard control, Central drugs standard control organisation directorate general

FDA Approved Drugs vs. Compounded Products …

• A generic drug is bioequivalent to a pioneer drug in dosage form, efficacy, safety and strength, route of administration, quality, and intended use

  Generic

FDA Regulation of Pharmaceutical Marketing

FDA Regulation of Pharmaceutical Marketing Tom Casola Executive Director. Commercial Operations. Merck & Co., Inc.

  Pharmaceutical, Regulations, Marketing, Fda regulation of pharmaceutical marketing

JULY 2013 Formulation switching of antiepileptic …

JULY 2013 A Report on the Recommendations of the Commission on Human Medicines from July 2013 . Formulation switching of antiepileptic drugs . Executive summary

  Switching, 2013, Formulation, 2013 formulation switching of antiepileptic, Antiepileptic, Formulation switching of antiepileptic

DRUG CLASSIFICATION SYSTEMS - …

THE PLAYERS •There are multiple classification systems available in the U.S. •3 main systems in this presentation: •Generic Product Identifier (GPI)

  System, Drug, Classification, Presentation, Generic, Drug classification systems

BRAND / GENERIC NAME FORMULATION …

BRAND / GENERIC NAME FORMULATION PRESENTATION CARDIOVASCULAR Antianginal MONICOR TABLETS Each uncoated tablet contains: 25x10's Blister Isosorbide Mononitrate Tablets BP Isosorbide-5-Mononitrate B.P. …

  Name, Presentation, Generic, Brand, Formulation, Brand generic name formulation, Brand generic name formulation presentation

Ipca Laboratories Ltd.

International APIs –Drug Master Files Sr. No. Name of the API US- FDA EU Canada- HPFB WHO Japan - PMDA Australia EDQM 1 Atenolol aaa aa aaa a aaa CEP aaaa 2 Artemether aaaa a aaa

  Name