Hi everyone,
My name is Bruno Silva, I’m pharmacist and I have worked 7 years in academy conducting reasearches in organic synthesis and medicinal chemistry area. Nowadays I work as Technical Documentation Analyst in Hypofarma Ltd, a pharmaceutical company of injectable medicines in Brazil. I’m driving an investigation in order to perform appropriate nitrosamine risk assessments and tests in our API’s and pharmaceutical products that attends regulatory expectations. In this context, there are some particularities related to pharmaceutical form injectable solution that I would like to discuss here in this community. I thank the welcome! Happy to belong to this group!
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Hello everyone! I’m Leticia, pharmacist from Uniao Quimica Farmaceutica in Brazil. I work at Drug Master file R&D team and since 2020 we developed a risk analysis questionnaire and evaluation method for drug products based on currently available guidelines. We have already evaluated our portfolio and we’re currently building risk assessment reports for submission dossiers of drug product marketing authorization application. Our risk assessment include API (manufacturing process, raw materials, impurities, degradation pathway, recovery process, cross contamination), finish drug product formulation (excipients) and packaging material. So excited to be part of this community!
Hello Everyone. My name is Jaime Ivan Ibarra, Current Quality Control Chemical Analyst for the Pharmaceutical Industry, located in Mexico, I am 9 years working in the QC area. working in the method development/validation department and Quality Control Laboratory for the analysis and release for raw & bulk materials, and primary packing materials. Happy to be part of this group and the continue learning of this regulatory agency
Hi all,
I´m Paulo, Biochemist-Pharmacist (USP), Master and Ph.D in Medicinal Chemistry, Synthesis and Drug Discovery (FCFRP-USP, University of East Anglia - UEA, UK; Johannes Gutenberg University of Mainz - JGU, Germany). My experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the Global Discovery Chemistry department. I have worked with regulatory affairs focusing on API, Drug Master File (DMF) and processes evaluation at Libbs Farmacêutica Ltda. Nowadays he is part of Integra consultancy team with focus on risk assessment of nitrosamines, control of mutagenic impurities, degradation and compatibility studies and quality audits.
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Hi everyone,
Myself Mittalkumar bhavsar & I’m working as Manager in analytical research and development department at Amneal pharmaceuticals limited.
I have been associated with Gas chromatography and Mass Spectroscopy team here.
Will see you all in future discussion.
Regards,
Mittalkumar Bhavsar.
Hi, my name is Juan Carlos Chavarria, i´m currently Head Analitycal R&D, of a Pharmaceutical company, we manufactured Generic drug pruducts. My interest to belong to this group is to exchange knowledge about the nitrosamines evaluation in commercially avaliable drugs products.
Hi, I am Sameer Kochar. I am pharmacy post graduate with more than 17 years of experience as formulation development scientist. I am team leader at Par formulation , India. With respect to nitorsamine my role is to perform risk assessment for formulation and select excipients and manufacturing process to minimize level in formulation to below daily acceptable intake.
I am excited to be part of the community wherein can learn and share our knowledge/ experience. Thanks
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Hi I am Sankaran Sivakumar, working as a Regulatory Affairs Manager in API bulk manufacturing industries since May 2010. I wish to be a part of this trending forum and will be posting my questions and ideas about Nitrosamines.
@Sankaran welcome to Nitrosamine Exchange… we look forward to you sharing your experience in API manufacturing related to Nitrosamines and its challenges. Thanks for accepting the invite.
@sameer welcome to Nitrosamine Exchange. I am really looking forward to you sharing the challenges and best practices when it comes to formulation strategy and Nitrosamines. A lot of debate about excipients’ role as indirect contributors for example. Looking forward to your contributions!
@Mittalkumar welcome to Nitrosamine Exchange. We have recently expanded our community scope to incorporate analytical challenges. I’m sure you and your team have dealt with several of them. Looking forward to your contributions and experience in the community.
Hello Everyone,
I am Dr. Vimarsh, Territory Business Manager-APAC region, Eurofins Advinus India.
I completed my PhD at University of Agricultural Sciences, Bangalore by 2014. Over time I have traversed across plant sciences to animal sciences industry segments, accumulating wealth-of knowledge and expertise in Preclinical and Regulatory testing domains across Pharma, Agrochemicals and REACH / Specialty chemical testing segments.
Presently i am serving as the primary BD contact for APAC business - GLP testing for Agrochemicals and REACH chemicals in Eurofins Advinus Limited India, offering Phsychem, Tox, Eco-Tox, Efate (c14) and Residue studies for major MNC’s.
Advinus being a premier OECD GLP lab since 1992, has developed its full compliance to all major regulatory submissions including US_FDA, EPA , REACH, ANVISA, SENASA, SENAVE and other global regulatory bodies as applicable.
We have been offering GLP testing services for various variants of Nitrosamines impurities across product range, and have been meticulous in offering fine-line scientific inputs in this segment of analysis of Nitrosamine variants.
It my pleasure to be here in this group and if anyone wishes the technical or analytical support in GLP data, please do ping me for best of service support.
Thank you all and indeed a great connect
Dr. Vimarsh
Territory Manager - APAC
Eurofins Advinus Limited
vimarsha.h@advinus.com
Mobile: +917019877390
Hello all,
I am Naga Satya, Heading QC operations ( API & OSD) at Lupin Limited, Bhopal. Happy to be part of this group.
Would love to see more on this .
Regards/Satya
Hello everyone,
I am PhD Müge GÜLELİ. I am working as WMINOLAB Laboratory Chief in R&D in World Medicine Pharmaceutical Industry. We conduct studies on nitrosamine analyzes for active substance, excipients and primary packaging. At the same time, we carry out extractable&leachable studies together with our team. I think there is much to be clarified about risk assessments for nitrosamines. I think I can learn a lot from you and we can help each other in many ways. I am happy to be a member of this community.
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Hi, My name is Dr. Nitish Sharma. I am currently working as assistant professor at National Institute of Pharmaceutical Education and Research. I worked with Sun pharmaceutical Ind Ltd & Dr. Reddys lab. I am having more than 18+ years of experience in analytical Research and development. I am having rich experience in evaluating the presence of nitrosamines in drug candidates. Happy to be part of this group.
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Hello Everyone,
I am happy to be part of this esteemed group. I am Ketan Agravat Consultant to pharma industry having ~ 3 decades of experience in Regulatory & Quality functions.
I support companies for Nitrosamine evaluation, risk assessment & regulatory submissions.
Looking forward to a fruitful interactions.
warm regards,
Ketan
Hi, My name is Pawan Ratra, Director in Global MS&T group at Teva Pharmaceuticals. I am based in NJ. I am supporting Nitrosamines risk assessment for the commercialized drug products. I am happy to be the part of the community to share and learn, and making the drug products more safer.
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Hi This is Dr Manish Tillashi, working in cadila pharmaceutical as senior manager.
I am looking here Genotoxic and nitroso impurities method development validation and their control strategy and spiked purged study of GTI impurities. There is basic challenges to under stand the source of nitroso impurity in KSM and solvents which is being used in process.
I am glad to be a part of this distinguished forum for the discussion of specialy on Nitroso impurities with elite scientist in Across pharma industries.
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I am looking forward to more discussion with you on Nitroso impurities topic.
Regards
Dr Manish Tillashi
9049544214
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It’s our pleasure to have you in this group sir
Regards
Dr Manish Tillashi
9049544214
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