Turntable Operation Basel

Lichtstrasse 35
4056 Basel Switzerland

Logistic Cover Sheet N° CH010400579685

to Batch Certificate

Product Name: FEMARA FCT 2.5MG TRI (3X10) RO

Customer's Product
Name: FEMARA FCT 2.5MG 3X10 RO

Global Valuated
Material N°: 709849 Batch N°: S0014
Batch Certificate N°: CH120200414437
Global Non Valuated
Material N°:

Customer N°: RO0100

Customer Name: NOVARTIS PHARMA SERVICES ROMANIA S. , BUCURESTI, SECTOR 2 ,
Romania

Ship to N°: RO0100 Country Code: RO

Ship to Party: NOVARTIS PHARMA SERVICES ROMANIA S. , BUCURESTI, SECTOR 2 ,
Romania

Pharma Outbound Sales Order No

Delivery No: 5001467923. 10 vs. End Customer: 1001188006
Shipped
Purchase Order N° Quantity: 3,058.000
of End Customer: 4700084438 Unit: PC

Additional Logistic Information:

Logistic Manager: Astrid RICO YATE Date: 27-SEP-2016

Page 1 / 7
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 Issued by:
Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein
Manufacturing License No:
504879
GMP Certificate No:
15-1650 FOR SOLIDS/ 15-1660 FOR STERILES

Batch Certificate
No CH120200414437

Product Name: FEMARA FCT 2.5MG TRI (3X10) RO

Dosage Form: Film-Coated Tablet
Package type: Blister
Package size: 3X10 Piece
Marketing Authorization No: 5026/2012/01
Country of Destination: Romania
Global Material No: 709849 Batch N°: S0014
Date of Manufacturing: 11-APR-2016
Release Date: 26-SEP-2016
Expiry date: MAR-2021
Production Qty: 3058.000 PC

Packaging Information
Product Name: FEMARA FCT 2.5MG TRI (3X10) RO
Global Material No.: 709849
Local Material No: 709849
Packaging Site: Novartis Pharma Stein AG
Schaffhauserstrasse
CH 4332 Stein
Manufacturing License: 504879
GMP Certificate No: 15-1650 FOR SOLIDS/ 15-1660 FOR STERILES

For Tests, Requirements, Results and Conclusions refer to the following Certificate(s):

Certificate No CH120100328725
Product Name: FEMARA FCT 2.5MG.013
Global Material N°: 859417 Batch N°: S0014
Local Material N°: 859417
Release Date: 04-JUL-2016
Manufacturing Site: Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein CH
Manufacturing License: 504879

Page 2 / 7
Page1 / 2 This certificate has been automatically generated.
The data have been approved by an Authorized Person.
 Issued by:
Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein
Manufacturing License No:
504879
GMP Certificate No:
15-1650 FOR SOLIDS/ 15-1660 FOR STERILES

Batch Certificate
No CH120200414437

Product Name: FEMARA FCT 2.5MG TRI (3X10) RO

Global Material No: 709849 Batch N°: S0014

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: Enzo SICA

Date and Time: 26-SEP-2016 13:27:05

Issuer of Certificate: Enzo SICA

Function: QA Associate
Date and Time: 26-SEP-2016 13:27:05

Page 3 / 7
Page2 / 2 This certificate has been automatically generated.
The data have been approved by an Authorized Person.
 Issued by :
Novartis Pharma Stein AG

Schaffhauserstrasse
4332 Stein
Switzerland
Certificate of Analysis
No CH120100328725

Product Name: FEMARA FCT 2.5MG.013

Global Material N°: 859417 Batch No : S0014

Date of Manufacturing 11-APR-2016

Testing Monograph: DP_3748092_A_R_1 Analysis No: 4100300847

Tests Requirements Results

Appearance: Colour of the tablets dark yellow Dark yellow

Appearance: Shape Round, slightly biconvex, bevelled Round, slightly biconvex,

edges bevelled edges

Appearance: Debossing code FV; CG FV; CG

Dimensions: Diameter 6.1 - 6.3 mm 6.2 mm

Dimensions: Thickness 2.9 - 3.4 mm 3.1 mm

Identity by TLC: Letrozole Corresponds to the reference Corresponds to the reference

Identity by HPLC: Letrozole Corresponds to the reference Corresponds to the reference

Mean mass 99 - 109 mg 105 mg

Page: 1/ 4 This Certificate has been automatically generated.

Page 4 / 7
The data have been approved by an Authorized Person.
 Issued by :
Novartis Pharma Stein AG

Schaffhauserstrasse
4332 Stein
Switzerland
Certificate of Analysis
No CH120100328725

Product Name: FEMARA FCT 2.5MG.013

Global Material N°: 859417 Batch No : S0014

Tests Requirements Results

Dissolution Letrozole after 30 minutes: Number of 6 - 24 6

units tested

Dissolution Letrozole after 30 minutes: Average Min 80 % 98 %

against Q-Value

Dissolution Letrozole after 30 minutes: Minimum - 98 %

Dissolution Letrozole after 30 minutes: Maximum - 99 %

Dissolution: Letrozole after 30 minutes Meets requirements of USP, Complies

Ph.Eur., JP

Related substances by HPLC: CGS 20268 Max 0.3 % 0.07 %

Related substances by HPLC: CGP 72744 Max 0.2 % < 0.05 %

Page 5 /2/
Page: 7 4 This Certificate has been automatically generated.
The data have been approved by an Authorized Person.
 Issued by :
Novartis Pharma Stein AG

Schaffhauserstrasse
4332 Stein
Switzerland
Certificate of Analysis
No CH120100328725

Product Name: FEMARA FCT 2.5MG.013

Global Material N°: 859417 Batch No : S0014

Tests Requirements Results

Related substances by HPLC: unspecified each Max 0.1 % < 0.05 %

Related substances by HPLC: unspecified total Max 0.3 % < 0.05 %

Related substances by HPLC: total Max 0.8 % 0.07 %

Content uniformity by HPLC - Letrozole: Number 10 - 30 10

of units tested

Content uniformity by HPLC - Letrozole: Minimum - 98.0 %

Content uniformity by HPLC - Letrozole: - 103.6 %

Maximum

Content uniformity by HPLC - Letrozole: Standard - 1.7 %

Deviation

Page 6 /3/
Page: 7 4 This Certificate has been automatically generated.
The data have been approved by an Authorized Person.
 Issued by :
Novartis Pharma Stein AG

Schaffhauserstrasse
4332 Stein
Switzerland
Certificate of Analysis
No CH120100328725

Product Name: FEMARA FCT 2.5MG.013

Global Material N°: 859417 Batch No : S0014

Tests Requirements Results

Content uniformity by HPLC - Letrozole: Max 15.0 % 4.0 %

Acceptance Value

Content uniformity by HPLC: Letrozole Meets requirements of USP, Complies

Ph.Eur., JP

Assay by HPLC: Letrozole 95.0 - 105.0 % 99.1 %

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 Alexander LEDITZNIG

Date and Time: 25-MAY-2016 15:11:03

Issuer of Certificate: Alexander LEDITZNIG

Function: Senior QA Specialist
Date and Time: 25-MAY-2016 15:11:03

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Page: 7 4 This Certificate has been automatically generated.
The data have been approved by an Authorized Person.