Turntable Operation Basel

Lichtstrasse 35
4056 Basel Switzerland

Logistic Cover Sheet N° CH010400482683

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°: S0116
Batch Certificate N°: CH120200349282
Global Non Valuated
Material N°:

Customer N°: RO0100

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

Ship to N°: RO0100 Country Code: RO

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

Pharma Outbound Sales Order No

Delivery No: 5001308024. 10 vs. End Customer: 1001066289
Shipped
Purchase Order N° Quantity: 478.000
of End Customer: 4700070617 Unit: PC

Additional Logistic Information:

Logistic Manager: Cynthia BRENDLEN Date: 10-JUN-2015

Page 1 / 7
Page 1 / 1
 Issued by:
Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein
Manufacturing License No:
504879
GMP Certificate No:
12-1616

Batch Certificate
No CH120200349282

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°: S0116
Date of Manufacturing: 28-NOV-2014
Release Date: 03-JUN-2015
Expiry date: OCT-2019
Production Qty: 478.000 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: 12-1616

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

Certificate No CH120100259924
Product Name: FEMARA FCT 2.5MG.008
Global Material N°: 856016 Batch N°: S0116
Local Material N°: 856016
Release Date: 13-JAN-2015
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:
12-1616

Batch Certificate
No CH120200349282

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

Global Material No: 709849 Batch N°: S0116

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: Claudia SCHNEYLIN

Date and Time: 03-JUN-2015 11:42:04

Issuer of Certificate: Claudia SCHNEYLIN

Function: QA Associate
Date and Time: 03-JUN-2015 11:42:04

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 CH120100259924

Product Name: FEMARA FCT 2.5MG.008

Global Material N°: 856016 Batch No : S0116

Date of Manufacturing 28-NOV-2014

Testing Monograph: DP_3748092_A_R_1 Analysis No: 4100247020

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 6.1 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 CH120100259924

Product Name: FEMARA FCT 2.5MG.008

Global Material N°: 856016 Batch No : S0116

Tests Requirements Results

Dissolution by HPLC: number of units tested N = 6, 12 or 24 N=6

Dissolution by HPLC - Letrozole after 30 minutes: Min 80 % 98 %

Q-Value

Dissolution by HPLC - Letrozole after 30 minutes: - 97 %

minimum

Dissolution by HPLC - Letrozole after 30 minutes: - 100 %

maximum

Dissolution by HPLC: 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 CH120100259924

Product Name: FEMARA FCT 2.5MG.008

Global Material N°: 856016 Batch No : S0116

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: number of units N = 10 or 30 N = 10

tested

Content uniformity by HPLC: Letrozole - minimum - 97.2 %

Content uniformity by HPLC: Letrozole - maximum - 101.4 %

Content uniformity by HPLC: Letrozole - relative - 1.7 %

standard 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 CH120100259924

Product Name: FEMARA FCT 2.5MG.008

Global Material N°: 856016 Batch No : S0116

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 % 99.2 %

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 Christoph LEIBL

Date and Time: 05-JAN-2015 15:50:54

Issuer of Certificate: Christoph LEIBL

Function: Senior QA Specialist
Date and Time: 05-JAN-2015 15:50:54

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