Turntable Operation Basel

Lichtstrasse 35
4056 Basel Switzerland

Logistic Cover Sheet N° CH010400417615

to Batch Certificate

Product Name: FEMARA FCT 2.5MG 3X10 RO

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

Global Valuated
Material N°: 709849 Batch N°: S0126
Batch Certificate N°: CH120200303325
Global Non Valuated
Material N°:

Customer N°: 100548

Customer Name: ULTRAMED PHARMA SRL , BUCURESTI, sector 1 , Romania

Ship to N°: 100899 Country Code: RO

Ship to Party: ULTRAMED PHARMA SRL , BUCHAREST , Romania

Pharma Outbound Sales Order No

Delivery No: 5001199415. 10 vs. End Customer: 1000997433
Shipped
Purchase Order N° Quantity: 3,798.000
of End Customer: order 24 - 19.06.2014 Unit: PC

Additional Logistic Information:

Logistic Manager: Bia KIM Date: 14-JUL-2014

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 Issued by:
Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein
Manufacturing License No:
1006204
GMP Certificate No:
12-1616

Batch Certificate
No CH120200303325

Product Name: FEMARA FCT 2.5MG 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°: S0126
Date of Manufacturing: 22-MAY-2014
Release Date: 09-JUL-2014
Expiry date: APR-2019
Production Qty: 3798.000 PC

Packaging Information
Product Name: FEMARA FCT 2.5MG 3X10 RO
Global Material No.: 709849
Local Material No: 709849
Packaging Site: Novartis Pharma Stein AG
Schaffhauserstrasse
CH 4332 Stein
Manufacturing License: 1006204
GMP Certificate No: 12-1616

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

Certificate No CH120100233838
Product Name: FEMARA FCT 2.5MG.010
Global Material N°: 858737 Batch N°: S0126
Local Material N°: 858737
Release Date: 01-JUL-2014
Manufacturing Site: Novartis Pharma Stein AG
Schaffhauserstrasse
4332 Stein CH
Manufacturing License: 1006204

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:
1006204
GMP Certificate No:
12-1616

Batch Certificate
No CH120200303325

Product Name: FEMARA FCT 2.5MG 3X10 RO

Global Material No: 709849 Batch N°: S0126

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 specifications in 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: Martina QUARTILLO

Date and Time: 09-JUL-2014 14:14:44

Issuer of Certificate: Martina QUARTILLO

Function: QA ASSOCIATE
Date and Time: 09-JUL-2014 14:14:44

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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 CH120100233838

Product Name: FEMARA FCT 2.5MG.010

Global Material N°: 858737 Batch No : S0126

Date of Manufacturing 22-MAY-2014

Testing Monograph: DP_3748092_A_R_1 Analysis No: 4100232949

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

Page1 / 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 CH120100233838

Product Name: FEMARA FCT 2.5MG.010

Global Material N°: 858737 Batch No : S0126

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 % 99 %

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 % 0.10 %

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

Page 5 / /7 4
Page2 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 CH120100233838

Product Name: FEMARA FCT 2.5MG.010

Global Material N°: 858737 Batch No : S0126

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 % 0.10 %

Content uniformity by HPLC: number of units N = 10 or 30 N = 10

tested

Content uniformity by HPLC: Letrozole - minimum - 97.5 %

Content uniformity by HPLC: Letrozole - maximum - 99.1 %

Content uniformity by HPLC: Letrozole - relative - 0.4 %

standard deviation

Page 6 / /7 4
Page3 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 CH120100233838

Product Name: FEMARA FCT 2.5MG.010

Global Material N°: 858737 Batch No : S0126

Tests Requirements Results

Content uniformity by HPLC: Letrozole - Max 15.0 % 1.2 %

acceptance value

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

Ph.Eur., JP

Assay by HPLC: Letrozole 95.0 - 105.0 % 98.3 %

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: 30-JUN-2014 16:09:31

Issuer of Certificate: Christoph LEIBL

Function: Senior QA Specialist
Date and Time: 30-JUN-2014 16:09:31

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Page4 This certificate has been automatically generated.
The data have been approved by an Authorized Person.