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The inspection was conducted by the German Health Authority at the company’s manufacturing unit from May 22-25, 2023.
Indoco Remedies Ltd. on Friday announced receiving a European Union Good Manufacturing Practice (EU GMP) certification from the
Health Authority of Germany for its manufacturing unit in Baddi under Solan district of Himachal Pradesh.
The competent Health Authority of Germany has awarded the certificate to Indoco Remedies’ manufacturing facility for oral dosage
forms situated in Solan, the company said in a filing to the stock exchanges on Friday.
The inspection was conducted by the German Health Authority at the company’s manufacturing unit from May 22-25, 2023.
The certification issued to Indoco Remedies reinstates that the company’s manufacturing site practices good manufacturing practices
and requirements, as per the EC Directive, the company said in a press release.
“The EU GMP certification for our site in Baddi adds to our consistent efforts to supply quality and affordable medicines in
Europe. We are committed to being cGMP compliant and supplying quality products to our customers and patients across the
globe,” said the MD of Indoco Remedies, Aditi Panandikar.
On Monday, Indoco Remedies announced that the United States Food and Drug Administration (USFDA) classified the company’s
facility in Goa as 'Official Action Indicated' (OAI).
As per the USFDA guidelines, an OAI indicates that objectionable conditions were found during inspections and regulatory or
administrative actions by US drug regulator are indicated.
After a brief spike, shares of Indoco Remedies gave up gains to end 0.4 percent lower at Rs 328.25.
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