Regulatory Aspects of Pharmaceuticals’ Exports in Gulf Coopération Council Countries

Pateriya, S; Janodia, M.; Deshpande, P. P.; Ligade, Virendra S; Talole, KB; Kulshrestha, T; Kamariya, Y; Musmade, Prashant B; Udupa, N.

doi:10.4103/0975-1483.80305

Cited by 8 publications

(6 citation statements)

References 1 publication

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“…Bahrain, Qatar, Saudi Arabia, UAE and Kuwait [14]. The import of superior drug products is under the control of Gulf Countries [15]. The occurrence of a good regulatory system admires the excellent variety of medicines.…”

Section: Modulesmentioning

confidence: 99%

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

Mohit

2019

ACCTRA

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Background: The product registration in rest of the world is a challenging task because they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. ASEAN used ACTD format and GCC used ICH CTD format for drug product Registration. ASEAN includes a group of countries like Singapore, Philippines etc. Whereas GCC includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE. Conclusion: This review article focuses on general regulatory requirements of registration of pharmaceuticals in ASEAN and GCC region.

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Section: Modulesmentioning

confidence: 99%

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

Mohit

2019

ACCTRA

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“…There are 23 Drug Manufacturing Units in UAE that create about 2500 medication at present, as opposed to 2010 when the country only had four manufacturing units (Nagraj, 2022). Foreign medicine that conforms to the UAE standards for safe consumption can be imported by UAE to maintain a steady supply of all types of medication within the country (Pateriya et al, 2011;Hassan et al, 2017). Generic medication in UAE has 60% lower prices than their branded counterparts (Nagraj, 2022).…”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical equivalence study of eight brands of Candesartan Cilexetil tablets marketed in the United Arab Emirates

Nessa,

George,

Khan

2023

Asian J Pharm Pharmacol

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Objectives: This work aimed to develop a simple HPLC method and apply in the pharmaceutical equivalence study of seven imported and one local product of candesartan cilexetil tablets (4, 8 and 16 mg).A simple RP-HPLC Methods: method was developed and validated in-terms of linearity, precision and accuracy, and applied in assay and dissolution study. The physical parameters and infrared scanning of the tablets were determined. The dissolution study was carried out at eight sampling data points to generate dissolution profiles for each brand and similarity factors of dissolution profiles were calculated.The developed HPLC method was accurate and precise with 2% relative standard Results:≤ deviation observed in intra-and inter-day precision. In assay, the product contained 100.74 to 102.52% candesartan cilexetil and the acceptance value for dosage content uniformity were less than 15. The dissolution test at 45 minutes the tablet released >80% drug. The infrared spectrum of eight products showed the similarity in the presence of functional groups. The dissolution profiles generated with eight sampling data points were compared with a reference product. Two products in 8 mg strength and one in 16 mg strength had similarity factors 50% similar in dissolution pattern as ≥ the reference products and were deemed as pharmaceutical equivalent.: The studied products met the Conclusion quality standards based on the physical parameters, assay contents, dosage content uniformity and dissolution test results compared to the United States Pharmacopeia44-National Formulary39 specification. The local product was more affordable and had the same pharmaceutical quality as the reference product.

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“…In the United Arab Emirates (UAE), three pharmaceutical companies are manufacturing and marketing ibuprofen tablet dosage forms; therefore, to meet the demand of UAE people, several other brands are imported from around the globe. For importation of foreign medicine into the UAE, various approvals are required to ensure the drugs that are brought into the country are compliant with the UAE standards for safe consumption (Balasubramanian et al, 2015;Hassan et al, 2017;Pateriya et al, 2011). An important step to confirm similarity and interchangeability in pharmaceutical products is to determine the pharmaceutical equivalence.…”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical equivalence study of marketed ibuprofen tablets of UAE using a validated RP-HPLC method

Nessa¹,

Salim²,

George³

et al. 2021

J Appl Pharm Sci

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Regulatory Aspects of Pharmaceuticals’ Exports in Gulf Coopération Council Countries

Cited by 8 publications

References 1 publication

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions

Pharmaceutical equivalence study of eight brands of Candesartan Cilexetil tablets marketed in the United Arab Emirates

Pharmaceutical equivalence study of marketed ibuprofen tablets of UAE using a validated RP-HPLC method

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