Several API manufacturers in China, India and Brazil found out of GMP compliance

GMP non compliance identified during the inspection of API manufacturing sites or due to the fact that a manufacturing site has not declared the willingness to be inspected caused again a number of consequences.

In the past weeks and months a number of manufacturers from China, India and Brazil were informed by EDQM that their CEP will be suspended or withdrawn. This information has also been published by EDQM and several EU Authorities in order to inform the manufacturer of the medicinal products who have been purchasing APIs from those API manufacturers. The Danish authority for example states: “If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period. If any medicines on the market contain this active substance from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect.

The suspension or withdrawal of CEPs has therefore immediate consequences for companies who purchase APIs from these manufacturing facilities.

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP):

R0-CEP 2006-304-Rev 00 Diclofenac Sodium
R1-CEP 2000-133-Rev 02 Diclofenac Sodium

The manufacturer concerned is:
Henan Dongtai Pharm Co., Ltd. East Changhong Road, China-456 150 Tangyin, Henan Province


R1-CEP 2003-156-Rev 00 / Caffeine
R0-CEP 2006-087-Rev 01/ Theophylline
R0-CEP 2007-345-Rev 01 / Theophylline-
ethylenediamine anhydrous
R0-CEP 2009-033-Rev 00 / Diprophylline
R0-CEP 2010-168-Rev 00 / Theobromine

The manufacturer concerned is:
CSPC Innovation Pharmaceutical Co., Ltd. ,
No. 36 Fuqiang Western Road, Luangcheng County, CN-051 430 Shijiazhuang City, Hebei Province, China


CEP 2005-119 Ciprofloxacin HCL
CEP 2002-082 Zolpidem Tartrate.
The manufacturer concerned is:
Aarti Drugs Limited, Plot No. G-60, M.I.D.C,
Tarapur, Tal. Palghar, District Thane, India-401
506 Tarapur, Maharashtra

The following CEPs have been suspended:

CEP 2000-055 Diclofenac NA
CEP 2005-072 Metformin HCL.

The manufacturer concerned is:
Aarti Drugs Limited, Plot No. G-60, M.I.D.C, Tarapur, Tal. Palghar, District Thane, India-401 506 Tarapur, Maharashtra


RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride

The manufacturer concerned is:
ANEK Prayog PVT LTD; 57/2 MIDC IND ,
Aera Dhatav; Raigad District, Roha,
Maharashtra, 402 116, India


CEP 1997-034-Rev 02 / Pilocarpine hydrochloride
CEP 2002-202-Rev 00 / Pilocarpine nitrate

The manufacturer concerned is:
Sourcetech Quimica LTDA, Rua Suica 3430,
Bairro Agua Petra, Brazil


R1-CEP 2004-139-Rev 00 / Theophylline
R1-CEP 2004-140-Rev 00 / Theophylline-ethylenediamine anhydrous
R1-CEP 2000-336-Rev 01 / Caffeine

The manufacturer concerned is:
Jilin Shulan Synthetic Pharmaceutical Co. Ltd.,
No. 2066, People´s Main Road, Shulan City,
China-132600, Jilin Province


R0-CEP 2009-267-Rev 00 / Erythromycin The manufacturers concerned are:
Mehta API Pvt. Ltd., Behind Remi Group,
Near Plot No. N-211, Village Kumbhavli,
Adjacent to M.I.D.C. Area , Boisar,
Taluka Palghar, District Thane , India-401 506 Boisar, Maharashtra


Please note that all reports about non-compliance issues or regulatory actions (such as FDA Warning Letters, CEP withdrawls, etc.) are taken with utmost carefullness from the respective regulatory website. Individuals should check the current situation of any company they wish to do business with to make sure that they have the most up-to-date information.


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