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Non-Compliance Report

The Certificate has been withdrawn, withdrawn date is : 2026-06-15

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State Institute For Drug Control

CERTIFICATE NUMBER: SK/001V/2026

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 SLOVAKIA confirms the following:

The manufacturer: MSN Life Sciences Private Limited

Site address:

Unit II Sy No. Parts Of 454 455 457 458 And 459, Chandampet Village, Shankarampet R Mandal, Medak, Telangana, 502255, India

OMS Organisation Id. / OMS Location Id.: ORG-100018316 / LOC-100027671

DUNS Number: 65-081-0141

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-10-15 , it is considered that it complies with:

The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.

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

Manufacture of active substance. Names of substances subject to inspection:

SACUBITRIL SODIUM(en)

VALSARTAN DISODIUM(en)

SACUBITRIL VALSARTAN SODIUM HYDRATE(en)

NALOXEGOL OXALATE(en)

EMPAGLIFLOZIN(en)

SILICON DIOXIDE(en)

SACUBITRIL VALSARTAN SODIUM ANHYDROUS(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SACUBITRIL SODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution and crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:VALSARTAN DISODIUM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution and crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SACUBITRIL VALSARTAN SODIUM HYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution, crystallisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:NALOXEGOL OXALATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution and crystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Manufacture of finished product

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:EMPAGLIFLOZIN

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution, crystallisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying, milling and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Manufacture of finished product intermediate

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SILICON DIOXIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution, crystallisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Manufacture of finished product intermediate

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:SACUBITRIL VALSARTAN SODIUM ANHYDROUS

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
dissolution, crystallisation and filtration

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.5.4  Other:
Manufacture of finished product intermediate

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Withdrawal comments in English: wrong

Withdrawal comments in National Language: chybný

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