Black list of pharmaceutical companies producingsubstandard medicines

Update: February 20one9

Roszdravnadzor has published a list of manufacturers of medicinal
the funds that received the highest amount in 20onefour
claims.

Among the foreign pharmaceutical companies are China (3 manufacturers),
India (2 companies), Belarus (2), Poland (2), one each
manufacturer from Ukraine, France, Germany, Slovenia. Total number
rejected parties, both one3 Russian and one3 foreign
manufacturers – about 200.

Main claims:

  • drug heterogeneity
  • violation of microbiological purity
  • presence of mechanical inclusions and impurities
  • deviations in the average weight of the tablets, different dosages,
    disintegration, solubility
  • violations of the packaging of drugs: mislabeling,
    package and description of the drug.

The list is sorted by the number of series.

The list of domestic manufacturers of medical products by
volume of rejected products, according to 20onefour data

No

payment order

Manufacturer

Qty

series

Qty

TN

Indicators
one LLC ASFARMA 2four 2 The average weight of the tablets, pH, Microbiological purity,
Disintegration
2 JSC “Synthesis” 2one 7 Impurities, Microbiological Purity, Description,
Packaging
3 OJSC “Uralbiopharm” 20 6 Quantitative determination, Adsorption capacity,
Посторонние примеси, Disintegration, Средняя масса таблеток,
Растворение, Микробиологическая чистота, Описание, Packaging,
Marking,
four LLC “YuzhFarm” oneeight one Quantitative determination: sodium benzoate, Authenticity: sodium
benzoate
five JSC NPK “ESKOM” one7 oneone Механические включения, Номинальные объем, Packaging,
Marking, Подлинность, Восстанавливающие вещества, Количественное
definition
6 JSC “Irbit HFZ” one7 6 Микробиологическая чистота, Описание, Packaging, Marking,
Средняя масса таблеток, Disintegration
7 CJSC “Medisorb” one6 3 Dissolution, Description, Microbiological Purity
eight Ozon LLC onefive 3 Disintegration, Описание, Однородность дозирования
9 Hippocrates Ltd. oneone five  Packaging, Marking, Описание, Количественное
definition
one0 JSC “Tatkhimpharm drugs” one0 7 Микробиологическая чистота, Описание, Packaging, Marking,
The contents of the package, Dissolution, Content mass
packaging,
oneone CJSC ALSI Pharma one0 3 Количественное definition
one2 JSC “Dalkharmharm” eight eight Disintegration, Механические включения, Marking,
Packaging,
one3 Samaramedprom OJSC eight 6 Количественное definition Описание

The list of foreign manufacturers of drugs by volume
забракованной продукции за 20onefour год

No

payment order

Manufacturer Name A country Qty series

Qty

TN

Indicators
one Elf Laboratories India oneeight 2 Механические включения, Количественное definition Посторонние
примеси, Родственные примеси, Подлинность, Packaging
2 OJSC “Borisov Medical Preparations Plant” Republic of Belarus one7 6 Микробиологическая чистота, Количественное definition
Uniformity of dosing, Authenticity, Dissolution, Average weight,
Механические включения,  Packaging
3 Merck Sante SAW France onefour five Количественное definition Растворение
four Shandong Shenglu Pharmaceutical Co. Ltd. China one0 five Packaging, Marking, Механические включения
five Lek dd Slovenia five 2 Количественное definition Подлинность
6 Mukos Emulsions GmbH Germany five one Marking
7 Янчжоу No3 Фармасьютикал Ко.Лтд China five one Packaging
eight Shrey Life Sciences Pvt. Ltd. India four 3 Количественное definition Механические включения,
Authenticity, Impurities,
9 C PS Oui Pharmaceutical Co.Ltd China four one Количественное definition
one0 Pharmaceutical plant “Polpharma” JSC Poland four one Количественное definition
oneone

Glaxosmith

Klein Pharmaceuticals SA

Poland four one Количественное definition
one2 RUP “Belmed drugs” Republic of Belarus 3 3 Marking, Packaging
one3 LLC Experimental Plant GNTsLS Ukraine 3 2 Packaging, Описание

Источник: www.roszdravnadzor.ru/news/one20

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