Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Tue 10 Nov 2026 23:59:10 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

Print Preview

Print Preview (Short version)

Back To Search

Hessian Office For Health And Care

CERTIFICATE NUMBER: DE_HE_01_GMP_2024_0062

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Germany confirms the following:

The manufacturer: Cadila Pharmaceuticals Limited

Site address:

1389 Trasad Road, Trasad Road, Dholka, 382225

OMS Organisation Id. / OMS Location Id.: ORG-100003616 / LOC-100000509

Other

(Human) wurde im Rahmen der in der Zulassung aufgefuehrten Hersteller mit Sitz ausserhalb des Europaeischen Wirtschaftsraumes einer Fernbewertung unterzogen gemaess - Art. 111 (4) der Richtlinie 2001/83/EG umgesetzt in deutsches Recht durch: SECT. 72a Abs. 1 Arzneimittelgesetz

Distant Assessment

From the knowledge gained during Distant Assessment of this manufacturer, the latest of which was conducted on 2023-08-04 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)
1.2.1.13 Tablets

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.13  Tablets
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.3 Chemical/Physical

Clarifying remarks (for public users):

The inspection was performed as a distant assessment, in addition video conference / virtual site tour of selected production and storage areas. This certificate is valid including 03.02.2025. - Ref. to 1.2.1.13, 1.5.1.13 and 1.5.2: only Etoricoxib 30 mg - 60 mg - 90 mg - 120 mg film-coated-tablets (were in the scope of inspection) - - Ref. to 1.6.3: only on-going stability testing - This certificate is in case of importation into the European Union only valid in connection with the current confirmation according to para 72a section 1 sentence 1 number 2 German Medicinal Products Act (Arzneimittelgesetz - AMG), issued to the importing companies after the inspection according to para 72a section 1 sentence 3 number 1 German Medicinal Products Act, and after confirming the validity of the inputs using the database according to para 67a German Medicinal Products Act.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.