Zamaporvint

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Sep 162024

Zamaporvint

READ ALL AT

https://newdrugapprovals.org/2024/09/15/zamaporvint/

Smartchem by Row2 Technologies

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Mar 092023

Are you aware of any Chemical Database which offers one stop solution to the Sourcing, R&D and Business Development department? Explore Smartchem to Quickly find Suppliers (Procurement), Customers (BD) & Synthetic pathways (R&D)

Is this the information you looking for? Evaluate SmartChem, lets schedule a demo. Try us once. You will use us for life.

Myself Anthony Crasto up for grabs as Advisor API & INT, Chem.

ANTHONY CRASTO, blogs Comments Off

Jan 232023

Admin note for myself . I am up for Grabs

I myself Dr Anthony Melvin Crasto Looking for a post retirement assignment as Advisor API & INT, Chem.
With 36 yrs rich experience, about dozen patents, 10000plus steps covered, 200 API targets, 30 plus products commercialization in plant in full career. Hands on knowledge of Synthesis, Process, scaleup, cost reduction, DOE , softwares etc

Kindly contact me
Dr Anthony Melvin Crasto
+919321316780
amcrasto@gmail.com

About myself
Dr Anthony Crasto
click on my website to know about me

Read http://amcrasto.weebly.com/
Also http://amcrasto.weebly.com/awards.html
Also
http://amcrasto.weebly.com/felicitations.html

1000 lakh google hits, 100lakh blog views, 10 lakh viewers in USA alone, all in 7 continents, 226 countries, 30 Indian and International awards, helping millions across the world

‘Top 10 Prominent & Great Personalities of the year 2022’ campaign by Fame Finders. ANTHONY CRASTO

ANTHONY CRASTO, award, blogs Comments Off

Jan 172023

‘Top 10 Prominent & Great Personalities of the year 2022’ campaign by Fame Finders.
Feeling great to be selected in the ‘Top 10 Prominent & Great Personalities of the year 2022’ campaign by Fame Finders. It is an online campaign to honour inspiring personalities and feature them in the upcoming edition of the top news sites, including – Deccan Chronicle/Asian Age/Deccan Herald, ANI, Zee5, Latestly, Lokmat Times, DailyHunt, Google News, JioNews, MSN and 70+ sites.Jan 16 2023

LINK https://www.deccanherald.com/brandspot/pr-spot/top-10-prominent-and-great-personalities-of-the-year-2022-announced-by-fame-finders-media-1181964.html

PRESS RELEASE COVERAGE REPORT- FAME FINDERS MEDIA
Headline – Top 10 Prominent and Dynamic Personalities to watch in 2023
SNo Publication Link

1 ANI https://www.aninews.in/news/business/business/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105508/

2 Dailyhunt

https://m.dailyhunt.in/news/india/english/ani67917250816496966-epaper-
anieng/top+10+prominent+and+dynamic+personalities+to+watch+in+2023-newsid-
n480757892?listname=newspaperLanding&index=22&topicIndex=4&mode=pwa&action=click

3 Zee5 https://www.zee5.com/articles/top-10-prominent-and-dynamic-
personalities-to-watch-in-2023

4 Latestly

https://www.latestly.com/agency-news/business-news-top-10-prominent-
and-dynamic-personalities-to-watch-in-2023-4952899.html

5 Kolkata News

https://www.kolkatanews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

6 Kulalimpur News

https://www.kualalumpurnews.net/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

7 Mumbai News

https://www.mumbainews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

8 Srilanka Source

https://www.srilankasource.com/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

9 Bignews
Network

https://www.bignewsnetwork.com/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

10 Nepal National https://www.nepalnational.com/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

11 South East Asia
Post

https://www.southeastasiapost.com/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

12 Bangkok News

https://www.bangkoknews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

13 Brunei News

https://www.bruneinews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

14 The Cambodia
News

https://www.thecambodianews.net/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

15 New Delhi News

https://www.newdelhinews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

16 Cambodian
times

https://www.cambodiantimes.com/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

17 Bangladesh Sun

https://www.bangladeshsun.com/news/273634192/top-10-prominent-
and-dynamic-personalities-to-watch-in-2023

18 Laos News

https://www.laosnews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

19 Nepal News

https://www.nepalnews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

20 Pakistan News

https://www.pakistannews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

21 India’s News

https://www.indiasnews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

22 Malaysian News

https://www.malaysianews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

23 Indonesian
News

https://www.indonesianews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

24 Sri Lankan News

https://www.srilankannews.net/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

25 Herald Globe

https://www.heraldglobe.com/news/273634192/top-10-prominent-and-
dynamic-personalities-to-watch-in-2023

26 West Bengal
Khabar

https://www.WestBengalKhabar.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

27 Vanakkam
Tamilnadu

https://www.VanakkamTamilnadu.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

28 UP Today

https://www.UPtoday.news/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

29 Telangana
Journal

https://www.Telanganajournal.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

30 South India
News

https://www.SouthIndiaNews.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

31 Punjab Live

https://www.PunjabLive.news/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

32 Odisha Post

https://www.OdishaPost.news/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

33 North East Times

https://www.NorthEastTimes.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

34 Maharashtra
Samachar

https://www.MaharashtraSamachar.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

35 Madhya Pradesh
Chronicle

https://www.MadhyaPradeshChronicle.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

36 Kashmir
Newsline

https://www.KashmirNewsline.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

37 Kashmir
Breaking News

https://www.KashmirBreakingNews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

38 Karnataka Live

https://www.KarnatakaLive.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

39 Jharkhand Times

https://www.JharkhandTimes.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

40 Indian Economic
Observer

https://www.IndianEconomicObserver.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

41 Himachal Patrika

https://www.HimachalPatrika.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

42 Haryana Today

https://www.HaryanaToday.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

43 Gujrat Varta

https://www.GujaratVarta.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

44 Delhi Live News

https://www.DelhiLiveNews.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

45 Chhattisgarh
Today

https://www.ChhattisgarhToday.in/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

46 Bihar Times

https://www.BiharTimes.news/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

47 Bihar 24×7 https://www.Bihar24x7.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

48 Andhra Pradesh https://www.AndhraPradeshMirror.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

49 World News
Network

https://www.worldnewsnetwork.net/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

50 Birmingham All
News Network

https://www.birminghamallnewsnetwork.com/news/top-10-prominent-
and-dynamic-personalities-to-watch-in-202320230316105500/

51 British Columbia
Times

https://www.britishcolumbiatimes.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

52 British News
Network

https://www.britishnewsnetwork.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

53 Buffalo Despatch https://www.buffalodespatch.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

54 Capitol Hill
Reporter

https://www.capitolhillreporter.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

55 Dubai City
Reporter

https://www.dubaicityreporter.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

56 East Asia All
News Portal

https://www.eastasiaallnewsportal.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

57 East Coast
America News

https://www.eastcoastamericannews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

58 England News
Portal

https://www.englandnewsportal.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

59 Eauropean Sun
Times

https://www.europeansuntimes.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

60 Federal
Despatch

https://www.federaldespatch.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

61 Florida Breaking
News

https://www.floridabreakingnews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

62 France Network
Times

https://www.francenetworktimes.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

63 London Channel
News

https://www.londonchannelnews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

Los Angeles
Evening
Despatch

https://www.losangeleseveningdespatch.com/news/top-10-prominent-
and-dynamic-personalities-to-watch-in-202320230316105500/

65 Maldives Star
Plus

https://www.maldivesstarplus.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

66 Miami News
Herald

https://www.miaminewsherald.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

67 Mountain View
Sentinel

https://www.mountainviewsentinel.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

68 NewYork
Despatch

https://www.newyorkdespatch.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

69 Richmond
Evening News

https://www.richmondeveningnews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

70 Sri Lanka Island
News

https://www.srilankaislandnews.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

71 Toronto Sun
Times

https://www.torontosuntimes.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

72 US World Today

https://www.usworldtoday.com/news/top-10-prominent-and-dynamic-
personalities-to-watch-in-202320230316105500/

73 Washington Dc
Despatch

https://www.washingtondcdespatch.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

74 WhiteHouse
News Time

https://www.whitehousenewstime.com/news/top-10-prominent-and-
dynamic-personalities-to-watch-in-202320230316105500/

///////

Dr. D Srinivasa Reddy appointed Director CSIR-IICT Hyderabad on 7th June 2022. A new assignment

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Jun 082022

STR2

Dr. D Srinivasa Reddy appointed Director CSIR-IICT Hyderabad India on 7th June 2022. A new assignment

This is on recommendation from search cum selection committee which met Prime minister who is president CSIR on 2nd may 2022

currently he is Director CSIR-IIIM jammu

we wish him all the best in New assignment

D. Srinivasa Reddy (DSReddy)

………….Srinivasa Reddy, Director, CSIR-IICT, Hyderabad, india

Pharmacodia Intelligence/”Internet+” big data information platform for pharmaceutical R&D

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Apr 122022

How are you? Please allow me to introduce Pharmacodia global drug Database & services to you briefly.
Pharmacodia Global Pharmaceutical Intelligence Platform is the first tier drug database for R&D Professionals including 40,000+ Drug data, 13,817,000+ Patents, 488,000+ Registration & Approval, 414,000+ Clinical Trials and 63,000+ items related regulatory policies.

Focusing on the drug research and development, Pharmacodia global database includes all small molecule drugs and biologics since 1982 (either in developing or marketed in the world). You may have a three days free trial for the Database.

Website: https://data.pharmacodiaglobal.com
If your colleagues and friends like to have a trial for the database, would you please forward the email to them, they can easily register an account and apply for a one day free trail. Thank you very much.

SCROLL UP OR DOWN

Sincerely yours,

IMG-20220412-WA0025

Jim
Chair of Pharmacodia Group
HongKong

If you are interested in knowing more about our database and services, please contact us through email/whatsApp:

global@pharmacodia.com

WhatsApp Number

Jin: +86 138 1146 5766

Sheryl: +86 138 1072 1280

Alex: +44 736 025 310

IMG-20220412-WA0026

SHERYL DING

CEO

IMG-20220412-WA0027

ALEX

Pharmaceutical eMES (eBMR) – why and how?

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Feb 212022

PRIYA RANJAN BELWARIAR

CEO, Laurus Infosystems

(Guest article)

Pharmaceutical eMES (eBMR) – why and how?

The “e Manufacturing Execution System” for pharmaceutical manufacturing is different from eMES in any other manufacturing industry. The difference primarily comes from the stringent Regulatory Compliance norms to be adhered to in Pharmaceutical Operations. In the Pharmaceutical Manufacturing the eMES is also referred as eBMR or “e Batch Manufacturing Record”.

The key objectives of implementing “e Manufacturing Execution Systems” (or eBMR) in Pharma Manufacturing are:

Achieve Compliancewith global regulatory norms, quality processes and ALCOA + norms.
Achieve Data integrityacross functions, systems and equipment records.
Audit readiness: Become ever ready for audit, with complete electronic records.
Paperless operation: Achieve paperless (or less paper) operation at the plant.

Pharmaceutical companies operate in one of the most dynamic and highly regulated environments. Regulatory audit frequencies have increased. Warning letters & import restrictions incidences have increased alongside. Many companies fail in clearing Regulatory Audits. Failing an audit results in over two years of business loss and huge expenses in achieving success with re-audit.

Most of the Pharmaceutical Manufacturing organizations have realized that they must implement a comprehensive eMES/eBMR systems for achieving the stated objective for long term business survival in todays regulated environment. However, the existing infrastructure scenario, inhibit moving forward with such implementation.

The scenario: Many Pharmaceutical Manufacturing Units are supplying to strongly regulated markets. They have a mix of the following infrastructure scenario:

Obsolete Equipment: Some equipment are obsolete in their design. These have no digital ability to record and communicate critical operations parameters for recording into BMR.
Semi-modern equipment: Some equipment have some digital ability to show records but are not enabled for automatic data transmission to SCADA database.

Modern Equipment: Some equipment are modern, PLC controlled and they can store digital data for some time. They still need to be integrated to SCADA (Supervisory Control And Data Acquisition) system.

There are also several cases of failures in implementing eMES solution provided by global brands providing the MES solution. Some of the key reasons of eMES implementation project failures are:

Complexity of the eMESSoftware systems. The level of complexity that can be digested across continents vary a lot. What is simple for some European countries may be too complex for Asian countries.
Design and Architecture of MES Solutions: A generic MES, modified for Pharma, would not succeed in Pharma. The eMES must be designed for Pharmaceutical operations, where the regulatory compliance requires flexibility in system to allow special process steps, for which there is no global best practices. The system must be architected for allowing new recipe, new product and new process to be quickly configured.
Right collaboration: Very often IT Team of Pharma companies would be good at handling the ERP Software and Level 3 & Level 4 IT systems. They would lack expertise of Level 1 and Level 2 Automation. Companies need to get right IT Solution providers capable of supplying and implementation right eMES along with Automation Solutions.
Comprehensive Solution: A comprehensive solution design would encompass eMES, integration with ERP, integration with SCADA and direct integration with many devices. The SCADA and Automation solution would include upgrading the semi modern equipment, connecting them along with modern equipment to SCADA. Adopting right strategy solution for obsolete equipment.

Phased implementation Strategy: There is variety of strategies for eMES implementation with complete automation integration. Designing and selecting right strategy is a Critical Success Factor.

The country, the facility location, equipment vendors, employees, organization culture, the product and market combination etc., makes every unit and unique unit. The eMES solution must be designed to suit each such unit. One solution would not fit all. The solutions must be configurable for taking care of the uniqueness. The solutions must be robust and maintainable.

Laurel MES™ product suite for “e Manufacturing Execution” is architected and designed for Pharmaceutical Manufacturing businesses to achieve compliance and audit readiness. Laurel MES™ comes along with Automation Solution and Systems Integration Solution which provides a complete, comprehensive and configurable solution. The drug product variants, market variants and product changeover challenges are addressed as required. Management dashboards and scorecards are fascinating. This solution is integration-ready for latest manufacturing and testing equipment.

Website: www.laurelmes.com . Write to: pr.belwariar@laurusis.com

Priya Ranjan Belwariar
CEO

Laurus Infosystems (India) Pvt. Ltd. 3^rd Floor, Plot # 8, 1^st Cross, Sadaramangala Industrial Area \| Whitefield Bangalore – 560 066 \| India	T +91 80 6152 7801 M +91 99 7242 4444 E pr.belwariar@laurusis.com W laurusis.com
	Next Generation Innovation

linkedin.com/in/pr-belwariar

Experienced Chief Executive Officer with a track record of leading Architecture Design and development of Software Products for Pharma Manufacturing Execution, Pharma R&D and making it successful in the market. Demonstrated strength in the information technology, software technologies, software services, Pharma, Chemical and Engineering industry. Skilled in Business Process, Architecture and Design of Enterprise Software and Computer Integrated Manufacturing. Strong business development professional with Engineering and MBA qualifications.

//////////////

What is investigational new drug (IND) Application? Neha parashar

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Feb 182022

What is Investigational New Drug (IND) Application? | Regulatory Learnings | Drug Regulatory Affairs

https://www.youtube.com/watch?v=NTOtI7HfE9I

GUEST AUTHOR

Neha Parashar, PMP®

Senior Manager Regulatory CMC | Regulatory Project Management | Regulatory Strategy | Biologicals

linkedin.com/in/neha-parashar

nehaparashar.niper@gmail.com

Welcome to the PharmaCamp with Neha. With this video channel. I would like to spread knowledge about the pharmaceutical world. This is a small initiative from my side to share knowledge with the world, as I feel education is the best gift one can receive or give back to society. Are you a working professional who wants to upgrade your skills? OR a student who wants to make a career in pharmaceuticals? OR are you a person who is interested to learn about the regulatory systems? Then this YouTube channel is for you. In this video, we will about US FDA Investigational New Drug (IND) Application. In my upcoming video, I will provide the stepwise approach for these IND applications. Therefore, this video will serve as the basis for those upcoming videos to explain the concept of INDs.

Welcome to PharmaCamp https://youtu.be/Rpvbzrsuu64

What is Clinical Trial? https://youtu.be/uAUXEsAC23o

About me: I am Neha Parashar, working as a Senior Manager in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor. LinkedIn: http://linkedin.com/in/neha-parashar

/////////

Anthony crasto is now Consultant Glenmark Lifesciences at Glenmark Life Sciences!

ANTHONY CRASTO, companies Comments Off

Jan 182022

I’m happy to share that I’m starting a new position as Consultant Glenmark Lifesciences at Glenmark Life Sciences!
17th Jan 2022, A new innings

I retired 16th Jan 2022 at 58 yrs from Glenmark . completed 16 yrs 2 months

30 plus years in the field of Process research

AS ON DEC2021 3,491,869 VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT

join me on Linkedin

Anthony Melvin Crasto Ph.D – India | LinkedIn

join me on Researchgate

RESEARCHGATE

join me on Facebook

Anthony Melvin Crasto Dr. | Facebook

join me on twitter

Anthony Melvin Crasto Dr. | twitter

+919321316780 call whatsaapp

EMAIL. amcrasto@amcrasto

/////////////////////////////////////////////////////////////////////////////

ANTHONY CRASTO, GLENMARK, CONSULTANT

ASMF

Uncategorized Comments Off

Sep 152021

What is a Drug Master File? - ppt download

What is an ASMF?

An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer.

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.

Final Guideline on Active Substance Master File Procedure – Revision 4 (PDF/358.28 KB)

Adopted

First published: 14/12/2018
Legal effective date: 17/06/2019
CHMP/QWP/227/02 Rev 4, EMEA/CVMP/134/02 Rev 4 Corr.

https://www.ema.europa.eu/en/documents/report/final-guideline-active-substance-master-file-procedure-revision-4_en.pdf

What is CEP and ASMF?

The ASMF holder may have an ASMF as well as a Certificate of Suitability (CEP) issued by EDQM for a single active substance. Generally, it is however not acceptable that the Applicant/MA holder refers to an ASMF as well as to a CEP for a single active substance of a particular MAA/MAV.

What is an ASMF in pharmaceutical industry?

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the …

What is the difference between Asmf and DMF?

An Active Substance Master File (ASMF) is the currently recognised term in Europe, formerly known as European Drug Master File (EDMF) or a US-Drug Master file (US-DMF) in the United States.

What is a EDQM CEP certificate?

To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM: a completed application form which includes your invoicing details.

Electronic Active Substance Master Files (eASMF)

ASMF Holders who are supplying substances to more than one Centrally Authorised Product (CAP) should submit their ASMF to the Agency once and not for each application.

The use of eCTD is mandatory for all for centralised procedure human ASMF submissions since 1 July 2016. The use of eCTD is mandatory for ASMFs used for DCP/MRP human procedures from 1 January 2018. Use of eCTD is mandatory for new national MAAs since 1 July 2018 and from 1 January 2019 for all other submission types. The relevant guidance should be followed and the technical eCTD validation criteria must be passed.

To ensure that the above is followed promptly, please refer to the human EMA Pre-authorisation guidance carefully and apply for an EMEA/ASMF/XXXXX number at your earliest convenience by submitting the EMEA/ASMF request form.

For veterinary medicines the accepted electronic format is VNeeS and NeeS and for ASMFs also exceptionally eCTD is allowed. More information can be found from the Veterinary Pre-submission guidance.

Please take a note of the voluntary EU ASMF Assessment worksharing. A different EU/ASMF request form should be submitted when requesting participation in the EU worksharing procedure.

It is very important to note that the above two initiatives are different.

The EMA eASMF submission rules are mandatory since 1st September 2013 and are applicable to all Centralised applications.
The EU Assessment worksharing initiative is valid for Centralised and Decentralised procedures.

A valid ASMF should have either an EMEA/ASMF number or an EU/ASMF number, depending on the intended use of the ASMF by its holder. When applying for EMEA or EU ASMF numbers, or submitting any documentation quoting these, please note that they are not inter-changeable. Only one ASMF number should be quoted.

It is mandatory to use XML delivery files for ASMF submissions using the eSubmission Gateway and the Web Client.

ACTIVE SUBSTANCE MASTER FILE (ASMF)

EMA Guideline on Active Substance Master File Procedure

EMA Additional guidance on documents relating to an Active Substance Master File

Templates for Active Substance Master File (ASMF) procedures

CMDh-CMDv Questions & Answers – Active Substance Master File (ASMF)

CMDh website for latest advice on ASMF procedures (Joint WG website including procedural guidance)

Training presentations on Active Substance Master File (ASMF) work sharing procedure:

ASMF worksharing – Introduction to the procedure (October 2018)
Requesting an EU_ASMF repository number (October 2018)
Submitting an initial worksharing ASMF (October 2018)
Determining the parent procedure (October 2018)
Assessment report template (October 2018)
Sharing assessment reports (October 2018)
Submitting a variation to an ASMF (October 2018)
Use of an approved ASMF in a new procedure (October 2018)

An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer. The purpose of an ASMF is to provide the Health Authorities (HAs) with complete information of the active substance used in a drug product to evaluate its suitability for the product. It also allows the Marketing Authorization Holder (MAH) of the product to take the responsibility for the quality of the active substance used in the product.

ASMF Content

An ASMF must contain all the scientific information related to the active substance. The information of an ASMF is divided into two parts:

Applicant Part (AP) – Contains information considered as non-confidential by the MAH
Restricted Part – Contains confidential information

ASMF Usage

An ASMF is submitted only to support a Marketing Authorisation Application (MAA) or Marketing Authorisation Variation (MAV). It is used for the following active substances:

Active substances that are new
Already existing active substances, which are excluded from the European Pharmacopoeia (Ph. Eur.)
Pharmacopoeial active substances, which are included in the (Ph. Eur.)

An ASMF holder is required to submit the following to the MAH holder:

A copy of AP’s latest version
A copy of the summary/detailed version of AP’s latest version
A copy of the letter of access, which has not been previously submitted for the same product

A single active substance can have both, an ASMF as well as a Certificate of Suitability (CEP). However, the MAH cannot refer to both the documents for a single active substance. In case, the information present in a CEP is insufficient, only then both the documents can be referred.

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