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Dr. Suhani Sinha

Associate Professor

Department of Regulatory Toxicology

National Institute of Pharmaceutical Education & Research Hajipur,

Bihar India – 844 102

E-mail: suhani[dot]sinha[at]niperhajipur[dot]ac[dot]in;

Faculty CV

Academics
Study programme Institute Division
ICSE (Senior Secondary) Sacred Heart School, Ranchi 1980-1992 First (Aggregate 84%, 95% in Math,86% in science)
CBSE (10+2) Delhi Public School, Ranchi 1992-1994 First (Aggregate 69% with PCMB)
Bachelor of Pharmacy Birla Institute of technology, Ranchi 1994-1998 First (Distinction) (77%)
Masters in pharmacy BITS Pilani, Rajasthan 1998-2000 First (CGPA 8.0)
Ph.D. In Pharmaceutical Sciences G.D.Goenka University, Gurugram Awarded in 2022

Research Areas
Pharmaceutical Research, Pharmacovigilance, Formulation Development, Total Quality Management, Quality Assurance, Clinical Research, Medical writing, Teaching and training, Global Pharmaceutical Business, Regulatory Procedures, Data Analytics.
Experience

  • Year Nov 2021 to Dec 2023: M/s. Krishat Pharma Ltd., Ibadan, Nigeria. Working as ‘Head- Manufacturing’.

Responsible for Dossier preparations as per eCTD format for registration of new products and Product Quality review documents for re-registration of existing products with NAFDAC. Overseeing the daily manufacturing activities, providing remote support to planning and production of tablets, capsules, and soft gelatin products, resolving issues of trouble shoot and quality compliance, recording of observations, corrective and preventive action, good documentation practices, monitoring and mentoring the plant team (which includes Quality Control, Quality Assurance, Production and Maintenance).

  • Year Oct 2017 to Nov 2021: GD Goenka University, Gurugram.

Worked as Assistant Professor in the Department of Pharmacy, School of Medical and Allied Sciences at the University. Taken lab Practical’s, delivered lectures and provided project guidance to B. Pharm and M. Pharm students. Research Lab/ Area of Research: 1. Development of dimethyl fumarate oral films. 2. Development of nanoparticles of dimethyl fumarate in oral 3. Development of tizanidine oral 4. Development of tizanidine nanoparticles in oral 5. Development of empagliflozin oral 6. Development of empagliflozin nanoparticles in oral 7. Quality by Design in Pharmaceutical Product

  • Year Jan 2002 –Oct 2017: M/s. Ranbaxy Laboratories Limited, Gurgaon (Now M/s. Sun Pharmaceutical Industries Limited); Worked in Product Development and Research Department to develop products in R&D and further scale up to exhibit stage for ANDA filings for US, Europe, India, and Emerging markets which includes tablets manufactured by wet granulation, dry granulation (compaction), direct compression, drug layering on tablets, fluid bed granulation, and pellet coating.

Worked on dosage forms which include immediate release and modified release tablets, Bilayer Tablets capsules, Powder for oral suspension, liquid orals, and semisolid dosage forms. Written development reports for products. Handled queries for US, EU, Russia, South Africa, Brazil, and other emerging markets and assisted in extension filings for approximately 300 dossiers across emerging markets for African countries, LATAM countries, South Africa and Russia. Handled API source derisking and source variation projects for Europe and emerging markets. Last Position held in the organization: Senior Research Manager/Senior Research Scientist. Responsibilities and Roles in the organization:

• Product development for US, Russia, and India markets as per USFDA guidelines, EMEA guidelines, DCGI guidelines and Russian MoH guidelines.
Total Quality management by implementing Six Sigma concepts and statistical data handling.
• Product registration in regulated as well as emerging markets and answer queries received on products from various MoH like UKMHRA, MCC South Africa, Russia MoH, Brazil MoH, Ukraine MoH, Kazakhstan
• Upgradation and modification of products already commercialised in various markets based on the changing regulatory scenario and as per market
• API source variation and de-risking approach for existing
• Preparation of documents as per QbD approach.
• Preparation of documents for DCGI
• Collation and evaluation of data for discussion before Pilot bioequivalence and Pivotal bioequivalence studies for US, Europe, and Russia
• Statistical data handling of products (JMP and Minitab)
• Co-ordinating Bioequivalence/Clinical trial studies
• Taken Exhibit batches/scale up/Pilot Bioequivalence batches for Europe and US market

  • Year Jan 2001- Jan 2002: M/s. Torrent Research Centre, Bhat; worked in formulation development department/ Laboratory, developed solid oral dosage forms and liquid formulations for India market using laboratory equipment and instruments, handled scale-up and production scale manufacture of immediate release tablets and sustained release tablets, capsules and suspensions using manufacturing/production
  • Year Jan2000 –Jul2000: M/s. Ohm Laboratories, New Jersey USA; worked in product development Assisted principal scientist in development of over-the-counter products (tablets), generic and branded tablets.

Distinctions

Patents published:

1. Water dispersible tablets of Lamotrigine. (International publication date: 02 December 2004; International Publication WO 2004/103340 A1)
2. Stable Lamotrigine pharmaceutical compositions and process for their preparation. (International publication date: 30 September 2004; International Publication WO 2004/082587 A3)
3. Stable Dapagliflozin preparations. (International publication date: 03 September 2015; International Publication WO 2015/128853 A1)
4. Dapagliflozin co-crystal formulations (International publication date: 07 December 2017; International Publication WO 2017/208136 A1)
5. Sustained release composition of dimethyl fumarate 202311012541A
6. Biocompatible nanoparticles of tizanidine hydrochloride in orodispersible films 202311010803A
7. Empagliflozin containing chitosan-alginate nanoparticles in orodispersible film. 202311009974 A.

Certifications:

1. Lifetime member of ‘Association of Pharmaceutical Teachers of India (APTI)’.
2. Registered Pharmacist of Haryana State Pharmacy Council (HSPC).
3. ‘Black Belt- Lean Six Sigma’ certified by Var Sigma Exemplar Global (Internationally recognized).
4. Course completion certificate for 4 days International Practical training workshop of ‘’Quality by design (QbD)’’-For practical implementation of Tools and Tactics of QbD and L6σ in Pharmaceutical Product Development, Conducted by Dr Shivang Chaudhary, Founder and CEO, QbD Expert.
5. Global certificate in Data Science awarded by INSAID.
6. 19 other certifications for participating in online webinars and interactive sessions hosted by various Universities, Industries and
7. Disseminated webinars and lectures on topics like ‘Pharmacovigilance programme of India’ and ‘Role of Intellectual property rights from innovation to start-ups, ‘Good Clinical Practices’.
8. Coloron Coating school training certificate and ACG Pharma technologies training certificate on Wurster

Research Publications
 1. Research Article: Chitosan-alginate core-shell-corona shaped nanoparticles of dimethyl fumarate in orodispersible film to improve bioavailability in treatment of multiple sclerosis: Preparation, characterization and biodistribution in rats, Journal of Drug Delivery Science and Technology, 64(2021), https://doi.org/10.1016/j.jddst.2021.102645. (IF:5.062)

2. Research Article: Development of biocompatible nanoparticles of tizanidine hydrochloride in orodispersible films: In vitro characterization, ex vivo permeation and cytotoxic study on carcinoma Current Drug Deliv. 2022 Mar 21.
Doi: 10.2174/1567201819666220321111338. Epub. PMID: 35319369. (IF: 3.758)

3. Research Article: Empagliflozin containing chitosan-alginate nanoparticles in orodispersible film: preparation, characterization,         pharmacokinetic evaluation, and its in-vitro anticancer Drug Dev Ind Pharm. 2022 Aug 1:1-41. Doi: 10.1080/03639045.2022.2108829. Epub ahead of print. PMID: 35913103. (IF: 3.727)

4. Review Article: Effects and safety profile of commonly used Herbal anti-diabetic (IF:1.858) DOI url: https://doi.org/10.30574/gscbps.2018.4.2.0067 (IF:

5. Review Article: Precision medicine as a promising tool to empower research in healthcare industry. DOI url: https://doi.org/10.30574/gscbps.2018.4.3.0068 (IF: 858)

6. Review Article: Enabling Process Improvement and Problem Solving in Pharmaceutical Industry through Six Sigma (Asian Journal of Biochemical and Pharmaceutical Sciences, Special Issue, pg- 74-85) (UGC Journal)

7. Review Article: Quality by design in Pharmaceutical Product (Acta Scientific Pharmaceutical Sciences (ISSN:2581-5423, Vol. 3, Issue January 2019) (IF:1.403)

8. Review Article: Oral Soluble Films: Attributes of the Polymeric Material and Critical Process Parameters for Designing Good Quality
DOI: 10.2174/2452271603666191210121944 (IF: 3.057)

9. Review Article: Nanoparticles loaded in consumable polymeric oral films: A smart dosage form design for oral DOI url: https://doi.org/10.30574/gscbps.2020.12.1.0153 (IF:1.858)

10. Review Article: Safety, efficacy, and quality profile of Ayurvedic anti-cancer DOI url:  https://doi.org/10.30574/gscbps.2020.12.1.0152 (IF:1.858)

11. Review Article: Mindfulness Regarding the Health Benefits of Basil (Tulsi) Leaves https://doi.org/10.32628/IJSRST218419

12. Review Article: A Review of Biologic anti- cancer DOI url: https://doi.org/10.30574/gscbps.2020.12.1.0151 (IF:1.858)