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Hessian Office For Health And Care

CERTIFICATE NUMBER: DE_HE_01_GMP_2024_0276

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: Lupin Limited

Site address:

Plot No 15 B Phase 1 A, Verna Industrial Area, Verna, Salcete, Vasco Da Gama, 403722

OMS Organisation Id. / OMS Location Id.: ORG-100004130 / LOC-100002997

DUNS Number: 67-760-0414

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC transposed in the following national legislation:Sect. 72a para 1 sent. 1 No. 2 in conjunction with sent. 3 No. 1 German Medicinal Product Act (import certificate).

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-11-20 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (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

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Clarifying remarks (for public users):

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. Scope of inspection: - Abacavir/Lamivudin 600 mg/300 mg film coated tablets, - Amifampridin 10 mg tablets - Emtricitabin/Tenofovirdisoproxil 200 mg/245 mg film coated tablets, - Levetiracetam 250 mg - 500 mg - 750 mg - 1000 mg film coated tablets, - Mirtazapin 15 mg - 30 mg - 45 mg film coated tablets, - Quetiapin 25 mg - 100 mg - 200 mg - 300 mg film coated tablets, - Tianesan 12,5 mg film coated tablets

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.