Coa 4702306076 Uperio 50 PDF

Turntable Operation Basel
Lichtstrasse 35
4056 Basel Switzerland
Logistic Cover Sheet N° CH010401003826

to Batch Certificate
Product Name: ENTRE FCT 24/26MG ALU (2X14) ID
Customer's Product
Name: UPERIO FCT 50MG (2x14)_ID
Global Valuated
Material N°: 740465 Batch N°: TUF50
Batch Certificate N°: IT100200190391
Global Non Valuated
Material N°:
Customer N°: ID0100

Customer Name: PT NOVARTIS INDONESIA , JAKARTA SELATAN , Indonesia
Ship to N°: ID0100 Country Code: ID

Ship to Party: PT NOVARTIS INDONESIA , JAKARTA SELATAN , Indonesia
Pharma Outbound Sales Order No

Delivery No: 5002249117. 10 vs. End Customer: 1001803058
Shipped
Purchase Order N° Quantity: 20,074.000
of End Customer: 4702306076 Unit: PC
Additional Logistic Information:
Logistic Manager: Aleksander Dosen Date: 05-JAN-2023
Page 1 / 34
Page 1 / 1
Issued by:
NOVARTIS FARMA SPA

Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy
Manufacturing License No:

N° AAMM - 139/2022
GMP Certificate No:
IT/160/H/2022
Batch Certificate No IT100200190391
Product Name: UPERIO 50 MG ALU (2x14) FCT

Dosage Form: Film-coated Tablet
Package type: Blister
Package size: 2X14 Tablets
Marketing Authorization No: DKI1701700417A1
Country of Destination: Indonesia
Global Material No: 740465 Batch N°: TUF50
Date of Manufacturing: 04-OCT-2022
Release Date: 07-DEC-2022
Expiry Date: SEP-2025
Production Qty: 20074.000 PC
Packaging Information
Global Material No.: 740465
Local Material No: 740465
Packaging Site:
NOVARTIS FARMA SPA
Italy
Manufacturing License: N° AAMM - 139/2022
GMP Certificate No: IT/160/H/2022
For Tests, Requirements, Results and Conclusions refer to the following Certificate(s):
Additional Documents:
Document Name: COA ENTRESTO FCT 50MG.012 1X1 FCT
Document References: MAT.860685 BATCH SDT346
Page 2 / 34
Page 1 / 2 This certificate has been automatically generated.
The data have been approved by an Authorized Person.
Issued by:
NOVARTIS FARMA SPA

Italy

N° AAMM - 139/2022
GMP Certificate No:
IT/160/H/2022
Batch Certificate No IT100200190391

Global Material No: 740465 Batch N°: TUF50
Certification Statement:
I hereby certify that the above information is authentic and accurate. This batch of product has been fabricated / manuf
actured, including packaging and quality control at the above mentioned site(s) in full compliance with GMP requirements
of the local Regulatory Authority and with the requirements of the Marketing Authorisation of the importing country.
The batch processing, packaging and analysis records were reviewed and found to be in compliance with GMP.
Authorized Person: Carolina Manzo

Date and Time: 07-DEC-2022 18:22:01
Release Type: BATCH RELEASE
Certificate Comment:
Analytical testing for NDMA and NDEA was performed and results comply
to Novartis requirements
Issuer of Certificate: Lucia Giordano

Function: AS&T Specialist
Date and Time: 05-JAN-2023 11:27:17
Page 3 / 34
Turntable Operation Basel
Lichtstrasse 35
4056 Basel Switzerland
Logistic Cover Sheet N° CH010400995210

to Batch Certificate
Product Name: ENTRESTO FCT 50MG.012
Customer's Product
Name:
Global Valuated
Material N°: 860685 Batch N°: SDT346
Batch Certificate N°: SG120200030595
Global Non Valuated
Material N°:
Customer N°: IT9901

Customer Name: NOVARTIS PHARMA AG , TORRE ANNUNZIATA , Italy
Ship to N°: 153552 Country Code: IT

Ship to Party: Novartis Farma SpA - Magazzino Inte , Torre Annunziata (NA) , Italy
Pharma Outbound Sales Order No

Delivery No: 5002228875. 10 vs. End Customer: 1001765270
Shipped
Purchase Order N° Quantity: 1,536,635.000
of End Customer: 5200039122 Unit: PC
Additional Logistic Information:
Logistic Manager: Tomaz Steharnik Date: 01-NOV-2022
Page 4 / 34
Page 1 / 1
Issued by:
Novartis Singapore
Pharmaceutical Manufacturing
Pte Ltd. 10 Tuas Bay Lane
637461
Singapore
MLMP0800001
GMP Certificate No:
DE_BY_05_GMP_2020_0021
Batch Certificate No SG120200030595

Strength/Potency: Sacubitril 24.3 mg
Valsartan 25.7 mg
Dosage Form: Film-Coated Tablet
Global Material No: 860685 Batch N°: SDT346
Date of Manufacturing: 04-OCT-2022
Release Date: 01-NOV-2022
Expiry date: 04-APR-2023
Production Qty: 1536635.000 PC
For Tests, Requirements, Results and Conclusions refer to the following Certificate(s):
Certificate No: SG120100043940

Global Material N°: 860685 Batch N°: SDT346
Local Material N°: 860685
Release Date: 01-NOV-2022
Manufacturing Site: Novartis Singapore
637461
Singapore
Manufacturing License: MLMP0800001
Certificate No: CH280100250500

Product Name: SACUBITRIL VALSARTAN NA HYDRATE/DS 07
Global Material N°: 832362 Batch N°: C0416
Manufacturing Site: Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein
Switzerland

Release Date: 27-JAN-2022
Schaffhauserstrasse
4332 Stein
Switzerland
Page 5 / 34
Issued by:
Novartis Singapore
637461
Singapore
MLMP0800001
GMP Certificate No:
DE_BY_05_GMP_2020_0021

Release Date: 27-JAN-2022
Schaffhauserstrasse
4332 Stein
Switzerland

Schaffhauserstrasse
4332 Stein
Switzerland
Page 6 / 34
Issued by:
Novartis Singapore
637461
Singapore
MLMP0800001
GMP Certificate No:
DE_BY_05_GMP_2020_0021

Certification Statement:
I hereby certify that the above information is authentic and accurate. This batch of product has been fabricated / manuf
actured, including packaging and quality control at the above mentioned site(s) in full compliance with GMP requirements
of the local Regulatory Authority and with the requirements of the Marketing Authorisation of the importing country.
The batch processing, packaging and analysis records were reviewed and found to be in compliance with GMP.
Authorized Person: Subash Sivan

Date and Time: 01-NOV-2022 03:13:55
Issuer of Certificate: Subash Sivan

Function: Senior QA Operations Specialist
Date and Time: 01-NOV-2022 03:13:55
Page 7 / 34
Issued by:
Novartis Singapore
637461
Singapore
MLMP0800001
GMP Certificate No:
DE_BY_05_GMP_2020_0021

Certificate Comment:
Conditionally released due to SACUBITRIL VALSARTAN NA HYDRATE/DS 07
Reference:
Conditional Release. Only for countries as defined in variation
files/Approval tracking of CR-0000060518. Nitrosamine testing is
performed on Valsartan IP. The testing was performed at Kurtkoy
(Novartis Saglik, Gida ve Tarim Urunleri San.Ve Tic. A.S - LC/MS/MS)
instead of SGS(Former ISL GC/MS/MS). Batch only suitable for countries
where the LC/MS/MS Method and Testing site Kurtkoy (Novartis Saglik,
Gida ve Tarim Urunleri San.Ve Tic. A.S) are registered or a registering
of this testing site is not required.
No deviation with potential impact on GMP compliance and /or compliance
with the marketing authorization occurred during manufacturing
operations.
Page 8 / 34
Issued by :
Novartis Singapore
637461
Singapore
Certificate of Analysis
No SG120100043940
Global Material N°: 860685 Batch No : SDT346
Date of Manufacturing 04-OCT-2022
Testing Monograph: DP 6002752 011 R02 AND DP 6002752 011 R0 Analysis No: 4100510585
3
Tests Requirements Results
Appearance by visual examination: Shape Ovaloid biconvex film-coated Complies

tablet with beveled edges
Appearance by visual examination: Color Violet white Violet white
Appearance by visual examination: Score Unscored Not scored
Appearance by visual examination: Debossment "NVR" on one side and "LZ" on LZ; NVR
the other side
Appearance: Approximate size Length: 13.1 mm; Width: 5.2 mm Complies
Identity by IR (ATR) - LCZ696 Corresponds to the reference Complies
Identity by HPLC - Valsartan Corresponds to the reference Complies
Identity by HPLC - Sacubitril Corresponds to the reference Complies
Page: 1/ 6 This Certificate has been automatically generated.

Page 9 / 34
Issued by :
Novartis Singapore
637461
Singapore
No SG120100043940
Mean mass 197.6 - 218.4 mg 208.0 mg
Dissolution of Valsartan: Number of units tested 6 - 12 Piece 12 Piece
Dissolution of Valsartan after 30 minutes by HPLC: Min 80 % 92 %

Average (Q value)
Dissolution of Valsartan: Minimum - 81 %
Dissolution of Valsartan: Maximum - 101 %
Dissolution of Valsartan after 30 minutes by HPLC: Meets the requirements of Ph.Eur., Complies
Final conclusion USP and JP
Dissolution of Sacubitril: Number of units tested 6 - 12 Piece 12 Piece
Page 102// 346

Page: This Certificate has been automatically generated.
Issued by :
Novartis Singapore
637461
Singapore
No SG120100043940
Dissolution of Sacubitril after 30 minutes: Average Min 80 % 92 %

(Q-value)
Dissolution of Sacubitril: Minimum - 80 %
Dissolution of Sacubitril: Maximum - 102 %
Dissolution of Sacubitril after 30 minutes by HPLC: Meets the requirements of Ph.Eur., Complies
Final conclusion USP and JP
Chiral purity by HPLC- CGP49309, based on the Max 1.0 % < 0.1 %
declared content of Valsartan
Chiral purity by HPLC- 534-06, based on the Max 0.2 % < 0.1 %
declared content of Sacubitril
Page 113// 346

Issued by :
Novartis Singapore
637461
Singapore
No SG120100043940
Degradation products by HPLC- Specified, Max 0.7 % < 0.1 %

identified 900-04, based on the declared content of
Sacubitril
Degradation products by HPLC- Any unspecified Max 0.2 % < 0.1 %
Degradation products by HPLC- Total degradation Max 0.5 % < 0.1 %

products, excluding 900-04 (FDC)
Content uniformity of Valsartan: Number of units 10 - 30 Piece 10 Piece

tested
Page 124// 346

Issued by :
Novartis Singapore
637461
Singapore
No SG120100043940
Content uniformity of Valsartan: Minimum - 98.0 %
Content uniformity of Valsartan: Maximum - 103.5 %
Content uniformity of Valsartan: Average - 101.0 %
Content uniformity of Valsartan: Acceptance value Max 15.0 % 4.1 %
Content uniformity of Valsartan by HPLC: Final Meets the requirements of Ph.Eur., Complies
conclusion USP and JP
Content uniformity of Sacubitril: Number of units 10 - 30 Piece 10 Piece

tested
Content uniformity of Sacubitril: Minimum - 98.1 %
Content uniformity of Sacubitril: Maximum - 103.7 %
Page 135// 346

Issued by :
Novartis Singapore
637461
Singapore
No SG120100043940
Content uniformity of Sacubitril: Average - 101.1 %
Content uniformity of Sacubitril: Acceptance value Max 15.0 % 4.1 %
Content uniformity of Sacubitril by HPLC: Final Meets the requirements of Ph.Eur., Complies
conclusion USP and JP
Assay by HPLC - Valsartan 95.0 - 105.0 % 101.8 %
Assay by HPLC - Sacubitril 95.0 - 105.0 % 102.2 %
Conclusion
The batch complies with the testing monograph. It is hereby certified that the above information is authentic and
accurate and that the analysis records have been reviewed and found to be in compliance with GMP.
Authorized Person Chen Loo Lim

Date and Time: 27-OCT-2022 07:36:38
Issuer of Certificate: Chen Loo Lim

Function: Quality Team Leader QC
Date and Time: 27-OCT-2022 07:36:38
Page 146// 346

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250500
Global Material N°: 832362 Batch No : C0416
Date of Manufacturing 23-SEP-2021

Retest date 22-SEP-2024
Testing Monograph: DS5001226001R06 Analysis No: 4100487908
Appearance white to almost white White
Appearance powder Powder
Particle size X10 by laser light diffraction Min 2 µm 3 µm
Particle size X90 by laser light diffraction Max 75 µm 16 µm
Identity by IR (Nujol) corresponds to the reference Corresponds to the reference
Identity by UV corresponds to the reference Corresponds to the reference
Identity by XRPD corresponds to the reference Corresponds to the reference
Stereoisomers CGP49309 by HPLC Max 0.5 % < 0.05 %
Stereoisomers 534-06 by HPLC Max 0.10 % < 0.05 %

Page 15 / 34
Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250500
Residual solvents Sum Headspace GC Max 0.5 % < 0.05 %
Residual solvents Acetone Headspace GC Max 0.5 % < 0.05 %
Residual solvents Ethanol Headspace GC Max 0.5 % < 0.05 %
Residual solvents Isopropyl alcohol Headspace GC Max 0.5 % < 0.05 %
Residual solvents Isopropyl acetate Headspace GC Max 0.5 % < 0.05 %
Residual solvents Benzene Headspace GC Max 2 ppm <= 0.5 ppm
Water (Karl Fischer) 4.3 - 5.7 % 5.0 %
Page 162// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250500
Heavy Metals (Ruthenium by ICP-MS) Max 10 ppm < 0.1 ppm
Metals Sum (Fe, Ni, Cu, Zn, Pb) by ICP-MS Max 10 ppm 4 ppm
Metals Ni by ICP-MS Max 2 ppm < 0.1 ppm
Metals Pb by ICP-MS Max 1 ppm < 0.1 ppm
Impurity by Flame AAS Calcium Max 300 ppm < 10 ppm
Chloride (argentometry) Max 500 ppm < 200 ppm
Related substances 900-04 by HPLC Max 0.3 % < 0.05 %
Related substances Unspecified, each by HPLC Max 0.10 % < 0.05 %
Related substances Total unspecified by HPLC Max 0.3 % < 0.05 %
Page 173// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250500
Total Related substances from tests 32001.01 and Max 0.6 % < 0.05 %
54001.03 by HPLC
Assay by Flame AAS calculated as sodium on an 7.17 - 7.93 % 7.53 %

anhydrous and solvent free basis
Content of LCZ696-ABA - 95.0 %
Assay Valsartan by HPLC (Reversed 50.3 - 52.4 % 51.6 %

Phase)(calculated as free acid on an anhydrous and
solvent free basis)
Assay AHU377 by HPLC (Reversed 47.6 - 49.6 % 48.6 %

solvent free basis)
Page 184// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250500
Assay LCZ696 by HPLC (Reversed 98.0 - 102.0 % 100.2 %

solvent free basis)
Conclusion
Authorized Person Eric Jacobs

Issuer of Certificate: Eric Jacobs

Function: TEAMLEADER QA OPERATIONS
Page 195// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252076

Retest date 05-OCT-2024
Stereoisomers CGP49309 by HPLC Max 0,5 % < 0,05 %
Stereoisomers 534-06 by HPLC Max 0,10 % < 0,05 %

Page 20 / 34
Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252076
Residual solvents Sum Headspace GC Max 0,5 % < 0,05 %
Residual solvents Acetone Headspace GC Max 0,5 % < 0,05 %
Residual solvents Ethanol Headspace GC Max 0,5 % < 0,05 %
Residual solvents Isopropyl alcohol Headspace GC Max 0,5 % < 0,05 %
Residual solvents Isopropyl acetate Headspace GC Max 0,5 % < 0,05 %
Water (Karl Fischer) 4,3 - 5,7 % 4,9 %
Page 212// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252076
Heavy Metals (Ruthenium by ICP-MS) Max 10 ppm 0,1 ppm
Metals Ni by ICP-MS Max 2 ppm < 0,1 ppm
Metals Pb by ICP-MS Max 1 ppm < 0,1 ppm
Impurity by Flame AAS Calcium Max 300 ppm < 10 ppm
Related substances 900-04 by HPLC Max 0,3 % < 0,05 %
Related substances Unspecified, each by HPLC Max 0,10 % < 0,05 %
Related substances Total unspecified by HPLC Max 0,3 % < 0,05 %
Page 223// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252076
Total Related substances from tests 32001.01 and Max 0,6 % < 0,05 %
54001.03 by HPLC
Assay by Flame AAS calculated as sodium on an 7,17 - 7,93 % 7,52 %

Content of LCZ696-ABA - 95,1 %
Assay Valsartan by HPLC (Reversed 50,3 - 52,4 % 51,2 %

solvent free basis)
Assay AHU377 by HPLC (Reversed 47,6 - 49,6 % 48,3 %

solvent free basis)
Page 234// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252076
Assay LCZ696 by HPLC (Reversed 98,0 - 102,0 % 99,5 %

solvent free basis)
Conclusion
Authorized Person Norbert Wall

Issuer of Certificate: Norbert Wall

Function: QA Operations Expert
Page 245// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252111

Stereoisomers CGP49309 by HPLC Max 0,5 % < 0,05 %

Page 25 / 34
Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252111
Residual solvents Sum Headspace GC Max 0,5 % 0,05 %
Residual solvents Acetone Headspace GC Max 0,5 % < 0,05 %
Residual solvents Ethanol Headspace GC Max 0,5 % 0,05 %
Residual solvents Isopropyl alcohol Headspace GC Max 0,5 % < 0,05 %
Residual solvents Isopropyl acetate Headspace GC Max 0,5 % < 0,05 %
Water (Karl Fischer) 4,3 - 5,7 % 5,1 %
Page 262// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252111
Heavy Metals (Ruthenium by ICP-MS) Max 10 ppm 0,1 ppm
Metals Ni by ICP-MS Max 2 ppm < 0,1 ppm
Metals Pb by ICP-MS Max 1 ppm < 0,1 ppm
Impurity by Flame AAS Calcium Max 300 ppm 12 ppm
Related substances 900-04 by HPLC Max 0,3 % < 0,05 %
Related substances Unspecified, each by HPLC Max 0,10 % < 0,05 %
Related substances Total unspecified by HPLC Max 0,3 % < 0,05 %
Page 273// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252111
Total Related substances from tests 32001.01 and Max 0,6 % < 0,05 %
54001.03 by HPLC
Assay by Flame AAS calculated as sodium on an 7,17 - 7,93 % 7,21 %

Content of LCZ696-ABA - 94,9 %
Assay Valsartan by HPLC (Reversed 50,3 - 52,4 % 51,2 %

solvent free basis)
Assay AHU377 by HPLC (Reversed 47,6 - 49,6 % 48,3 %

solvent free basis)
Page 284// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100252111
Assay LCZ696 by HPLC (Reversed 98,0 - 102,0 % 99,6 %

solvent free basis)
Conclusion
Authorized Person Norbert Wall

Issuer of Certificate: Norbert Wall

Function: QA Operations Expert
Page 295// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250521

Stereoisomers CGP49309 by HPLC Max 0.5 % < 0.05 %

Page 30 / 34
Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250521
Residual solvents Sum Headspace GC Max 0.5 % 0.05 %
Residual solvents Acetone Headspace GC Max 0.5 % < 0.05 %
Residual solvents Ethanol Headspace GC Max 0.5 % 0.05 %
Residual solvents Isopropyl alcohol Headspace GC Max 0.5 % < 0.05 %
Residual solvents Isopropyl acetate Headspace GC Max 0.5 % < 0.05 %
Water (Karl Fischer) 4.3 - 5.7 % 5.0 %
Page 312// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250521
Heavy Metals (Ruthenium by ICP-MS) Max 10 ppm 0.1 ppm
Metals Ni by ICP-MS Max 2 ppm < 0.1 ppm
Metals Pb by ICP-MS Max 1 ppm < 0.1 ppm
Impurity by Flame AAS Calcium Max 300 ppm 13 ppm
Related substances 900-04 by HPLC Max 0.3 % < 0.05 %
Related substances Unspecified, each by HPLC Max 0.10 % < 0.05 %
Related substances Total unspecified by HPLC Max 0.3 % < 0.05 %
Page 323// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250521
Total Related substances from tests 32001.01 and Max 0.6 % < 0.05 %
54001.03 by HPLC
Assay by Flame AAS calculated as sodium on an 7.17 - 7.93 % 7.56 %

Content of LCZ696-ABA - 95.0 %
Assay Valsartan by HPLC (Reversed 50.3 - 52.4 % 51.1 %

solvent free basis)
Assay AHU377 by HPLC (Reversed 47.6 - 49.6 % 48.4 %

solvent free basis)
Page 334// 345

Issued by :
Novartis Pharma AG
Lichtstrasse 35
4056 Basel
Switzerland
No CH280100250521
Assay LCZ696 by HPLC (Reversed 98.0 - 102.0 % 99.4 %

solvent free basis)
Conclusion
Authorized Person Eric Jacobs

Issuer of Certificate: Eric Jacobs

Function: TEAMLEADER QA OPERATIONS
Page 345// 345


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Turntable Operation Basel

Logistic Cover Sheet N° CH010401003826

Product Name: ENTRE FCT 24/26MG ALU (2X14) ID

Customer N°: ID0100

Ship to N°: ID0100 Country Code: ID

Pharma Outbound Sales Order No

Additional Logistic Information:

Logistic Manager: Aleksander Dosen Date: 05-JAN-2023

NOVARTIS FARMA SPA

Manufacturing License No:

Batch Certificate No IT100200190391

Product Name: UPERIO 50 MG ALU (2x14) FCT

NOVARTIS FARMA SPA

Manufacturing License No:

Batch Certificate No IT100200190391

Authorized Person: Carolina Manzo

Release Type: BATCH RELEASE

Issuer of Certificate: Lucia Giordano

Logistic Cover Sheet N° CH010400995210

Product Name: ENTRESTO FCT 50MG.012

Customer N°: IT9901

Ship to N°: 153552 Country Code: IT

Pharma Outbound Sales Order No

Additional Logistic Information:

Logistic Manager: Tomaz Steharnik Date: 01-NOV-2022

Batch Certificate No SG120200030595

Product Name: ENTRESTO FCT 50MG.012

Certificate No: SG120100043940

Certificate No: CH280100250500

Certificate No: CH280100252076

Batch Certificate No SG120200030595

Certificate No: CH280100252111

Certificate No: CH280100250521

Batch Certificate No SG120200030595

Product Name: ENTRESTO FCT 50MG.012

Authorized Person: Subash Sivan

Issuer of Certificate: Subash Sivan

Batch Certificate No SG120200030595

Product Name: ENTRESTO FCT 50MG.012

Product Name: ENTRESTO FCT 50MG.012

Global Material N°: 860685 Batch No : SDT346

Date of Manufacturing 04-OCT-2022

Tests Requirements Results

Appearance by visual examination: Shape Ovaloid biconvex film-coated Complies

Appearance by visual examination: Color Violet white Violet white

Appearance by visual examination: Score Unscored Not scored

Appearance: Approximate size Length: 13.1 mm; Width: 5.2 mm Complies

Identity by IR (ATR) - LCZ696 Corresponds to the reference Complies

Identity by HPLC - Valsartan Corresponds to the reference Complies

Identity by HPLC - Sacubitril Corresponds to the reference Complies

Page: 1/ 6 This Certificate has been automatically generated.

Product Name: ENTRESTO FCT 50MG.012

Global Material N°: 860685 Batch No : SDT346

Tests Requirements Results

Mean mass 197.6 - 218.4 mg 208.0 mg

Dissolution of Valsartan: Number of units tested 6 - 12 Piece 12 Piece

Dissolution of Valsartan after 30 minutes by HPLC: Min 80 % 92 %

Dissolution of Valsartan: Minimum - 81 %

Dissolution of Valsartan: Maximum - 101 %

Dissolution of Sacubitril: Number of units tested 6 - 12 Piece 12 Piece

Page 102// 346

Product Name: ENTRESTO FCT 50MG.012