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Rajkiran Kolakota, K. Padmaja* 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani college of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A B S T R A C T The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health ... Read More »
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Registration Steps Followed for Filing of Biosimilars in Regulated and Emerging Markets
Rajkiran Kolakota1 and I. Jhansi Lakshmi*2 1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P. A B S T R A C T The main aim is to facilitate the regulatory requirements for the approval process of Biosimilar in Regulated and Emerging markets by establishing the foundation for a harmonized regulatory standard to meet ... Read More »
HPLC Estimation of Vildagliptin in Bulk and Pharmaceutical Formulations
Rajkiran Kolakota*, P. Anil Naidu, Uha Rani Duppala Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP A B S T R A C T A simple and reproducible method was developed for Vildagliptin by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Vildagliptin was separated on Altima C18 column (150 x 4.6mm, 5μm), using Phosphate ... Read More »
Evaluation of Anti Hypertensive Activity of Thespesia Populena Leaf Extract on Albino Rats
K. Sumanth Kumar*, P. Venkatesh, S. Bhavyasri, P. Sravani Chowdary, P. Pragathi Reddy, E. Nagarjuna, D. Vamsee Krishna Jagans Institute of Pharmaceutical Sciences, Jangala kandriga (V), S.P.S.R Nellore-524346 A B S T R A C T Hypertension remains a major health problem in most countries because of its impact on the population mortility and morbidity. Hypertension is becoming one of ... Read More »
HPLC Estimation of Levofloxacin in Bulk and Pharmaceutical Formulations
Rajkiran Kolakota*, Y. Rupavathi Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P ABSTRACT A HPLC method was developed and validated to determine trace amounts of levofloxacin related substances & degradation products in its formulation. Separation of levofloxacin from impurity A, impurity B, impurity C and unknown degradation products was achieved on a YMC-Pack Pro ... Read More »
HPLC Estimation of Paroxetine in Bulk and Pharmaceutical Formulations
Rajkiran Kolakota*, P. Anil Naidu, Uha Rani Duppala Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP A B S T R A C T A simple and reproducible method was developed for Paroxetine by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Paroxetine was separated on ODS column (150 x 4.6 mm, 5μm), using Phosphate ... Read More »
Modernization of Medical Devices and Market-Oriented Economies in United Kingdom
Rajkiran Kolakota*, D. Usharani Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P A B S T R A C T The purpose of this study is to illuminate the importance of medical devices, regulatory requirements for the registration of medical device manufacturers in U.K. The controversy for companies developing and producing medical device ... Read More »
A new RP-HPLC method development and validation for Simultaneous estimation of lumefantrine & artemether using bulk and Pharmaceutical Dosage Forms
Rajkiran Kolakota*, G. Sai Krishna Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P. A B S T R A C T A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for Simultaneous Estimation of Lumefantrine and Artemether in Combined Dosage Form. The chromatographic separation ... Read More »
An Insight of Microsponges for Acne Treatment
Vinay Richards R 1*, Dr. Bhuwanendra Singh2 1Research Scholar, Department of Pharmaceutical Sciences, Shri Venkateswara University, Venkateshwara Nagar, Rajabpur Gajraula, Amroha, UP-244236. 2Research Supervisor, Department of Pharmaceutical Sciences, Shri Venkateswara University, Venkateshwara Nagar, Rajabpur Gajraula, Amroha, UP-244236. A B S T R A C T Dermatological disorders have a significant psychosocial impact, impairing the patient’s life significantly. Topical therapy is ... Read More »
Study Process of Drug Approval Process in European Union via Centralized Procedure (From 2015-2018)
Rajkiran Kolakota*, I. Uma Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP. A B S T R A C T The current scenario of this article mainly highlights about the medicinal products that are highly synchronized in European Union. Medicinal products undergo an elaborate system of approvals that governs how, when, where, and ... Read More »
