Jun
13
2016

NDA and BLA approved by USFDA in Jan-Feb 2016

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Below are the list of products approved by USFDA as NDA or BLA from January 2016 to February 2016. The list provides information about drug name, Active ingredient, NDA type, Review Classification, Company and Approval date. Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type * Review Classifi- cation ** Company Approval Date E-Z-HD (NDA # 208036) BARIUM SULFATE 7 S BRACCO 01/11/2016 READI-CAT 2 (NDA # 208143) BARIUM SULFATE 7 S BRACCO […]

Jun
9
2016

Worldwide Regulatory Agency

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Here we are providing website link for Worldwide Regulatory Agency at one place for user convenience. Country wise Regulatory agency websites India www.cdsco.nic.in http://www.cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf http://rdpp.csir.res.in/csir_acsir/Home.aspx   USA http://www.fda.gov/drugs/default.htm Orange book:http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm Guidelinespage:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm Dissolution methods: http://www.accessdata.fda.gov/scripts/cder/dissolution/ Inactive ingredients daily intake limits:http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm DMFdetails:http://www.usactives.com/z1/search.php?zoom_query=tramadol&zoom_per_page=5&zoom_and=1&zoom_sort=0   European Home page: www.emea.europa.eu Guidelines page: http://www.emea.europa.eu/htms/human/humanguidelines/quality.htm   UK Home page: www.mhra.gov.uk Guidelines page: http://www.mhra.gov.uk/Publications/Regulatoryguidance/index.htm   Australia Home page: www.tga.gov.au Guidelines page: http://www.tga.gov.au/pmeds/pmeds.htm ARTG: https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuMedicines?OpenView&Start=8661&Count=20   International conference on harmonization (ICH) Home page: www.ich.org […]

Jun
8
2016

Drugs approved in Indian from January 01, 2016 to May 31, 2016

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CDSCO or DCGI has provided the list of drugs approved in India from January 01, 2016 to May 31, 2016 as provided below;   S.No Name Of Drug Indication Date of issue 1 Nintedanib soft Gelatin Capsule 100/150mg For the treatment of Idiopathic Pulmonary Fibrosis (IPF). 11.03.16 2 Cisatracurium Besylate Bulk & 2mg/ml injection As an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.   14.03.16 3 […]

Jun
4
2016

Indian Patents (Amendment) Rules, 2016

Indian patent

In the field of Intellectual Property Right, recently major changes happened. First National IPR Policy has been finalized and approved by The Ministry of Commerce and Industry, Government of India, on May 13, 2016 and second was Patents (Amendment) Rules, 2016 which was comes as a surprise on May 16, 2016 because it was directly came in to force without draft circulation for comment. The highlight of the changes in new Patents (Amendment) Rules, 2016 […]

Jun
2
2016

National IPR Policy for INDIA is final now

Patent

After so much drama and noise on National IPR Policy, finally (and silently), The Ministry of Commerce and Industry of the Government of India released it on May 13, 2016. The main purpose and object of the National IPR Policy is to increase awareness, enforcement and importance of IPR in India.. Main features of IPR Policy are listed out below: Education and Awareness: Educate and promote IPR education to judiciary, enforcement agencies, industries and academic […]

Jun
1
2016

What you want to know about 505(b)(2) ?

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  The below information we found very useful and informative for readers. This below information is taken from CamargoPharma. Where does the name “505(b)(2)” come from? 505b2 The “505(b)(2)” name comes from Section 505 of the Federal Food, Drug, and Cosmetic Act. Section 505(b)(2) was added by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). Section 505 has subsections that describe 3 types of applications: 505(b)(1) – new molecular entity […]

Jun
1
2016

MSF Access..A Compaign for access of medicines to poor

Tablets

Médecins Sans Frontières is a private international association. The association is made up mainly of doctors and health sector workers and is also open to all other professions which might help in achieving its aims. All of its members agree to honour the following principles: Médecins Sans Frontières provides assistance to populations in distress, to victims of natural or man-made disasters and to victims of armed conflict. They do so irrespective of race, religion, creed […]

May
31
2016

Japan’s WDB to launch drug contract R&D business in India

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Japan’s WDB Holdings Co. announced on May 11 that its Indian subsidiary specializing in pharmaceutical contract research business will start operations on May 16. WDB Holdings of Himeji, Hyogo Prefecture, is engaged in human resource service business in the biochemical sector and assists in the development of pharmaceuticals. The subsidiary, WDB India Private Ltd., was established in Hyderabad in the southern state of Telangana in February this year. It is capitalized at 20 million rupees […]

Oct
13
2015

Pharmacy profession from retail to e-tail

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E-commerce has played very important role in our life style and our shopping style. Now all are addicted to online shopping for each and every need of life wither it is a mobile or clothes or food or even raw vegetables. Recently this trend has included pharmaceutical products including medicines. Recently in May 2015, one of the biggest online shopping portal Snapdeal was involved in selling prescription only medicines online without any proper permission or […]

Oct
12
2015

MOU between MHRA (UK) and CDSCO (India) for public safety

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (5 October 2015) signed a Memorandum of Understanding (MOU) with its counterpart body in India. This agreement will increase collaboration between the 2 countries in the area of medicines and medical devices with the aim of further improving public safety in the 2 countries. This is the first MOU agreed with the Central Drugs Standard Control Organisation (CDSCO), part of the Ministry of Health and […]

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