Dr Giridhar Thota

Chief Executive Officer

Shodhana Laboratories Ltd

Plot N0 2425 & 26 Phase-I IDA leedimetlaHyderabad Telanganalndia

Our Reference: 2014/048417

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A1, stralian Government

Department of HealthTherapeutic Goods Administration

Dear Dr Gindhar Thota,

Subject: Issue of GMP certificate Mr20, .6-CE-00278-,.

Please find enclosed the GMP certificate for your manufacturing premises.

You may note its changed layout with new security provisions: blue and grey curveddotted lines at the bottom half of each page. These provisions are intended to preventunauthorised copying as part of a process to introduce issuing certificates electronically inthe near future. This will also include using electronic signatures only.

The certificate remains valid only if re-inspections are conducted when scheduled by theTherapeutic Goods Administration. The inspection frequency is riot a reflection of theexpiry date shown on the certificate but is consistent with the re-inspection frequencyapplicable to Australian manufacturers of the same class of products.

The Therapeutic Goods Administration will contact the relevant sponsor/s to arrange there-inspection of your facility,

Yours sincerely,

Robert PrestridgeManufacturing Quality Branch

19 Ianuary 2016

Contact: GMP

Email:

PO Box I 00 Woden ACT 2606 ABN 40 939406804

Phone: 0262328444 Fax: 0262031605 Email: !!,^!!It s://WWW. t a. ov au

Phone: +61262216865 Fax: +61262328426

TGA^;:^^;^:^

Certificate of GMP Coinp iance of a Manufacti. Irer

of Active Pharmaceutical Ingredients (APIS)

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Australian Government

Department of HealthTherapeutic Goods Administration

The Therapeutic Goods Administration, the Competent Authority of Australia, confirms that thismanufacturer of Active Pharmaceutical Ingredients (APIS) has been inspected followingsection/s 2511)(g}, 26(INg) and/or 26A(3) of the Therapeutic GoodsAct1989in connectionwith marketing authorisation/s listing API manufacturers located outside Australia.

From the knowledge gained during inspection of this manufacturer, the latest of which wasconducted on 16 Iune 2015 to 19 Iune 2015, it is considered that the manufacturer complieswith the Good Manufacturing Practice requirements of the PIC/S Guide to Good ManufacturingPractice for Medicinal Products - 15 Ianuary 2009.

This certificate reflects the status of the manufacturing site at the time of the inspection notedabove. This certificate remains valid until the expiry date provided that re-inspections areconducted as determined by the Therapeutic Goods Administration as the issuing Authority.This certificate should not be relied upon to reflect the compliance status after the expiry date.

Certificate Number:

Shodhana Laboratories Ltd

Manufacturing Site Address:

Plot N0 2425 & 26 Phase-I IDA leedimetlaHyderabad Telangana India

M1-2016-CE-00278-I

Issued to:

EXPIRY DATE: 1.9 December 201.8

ISSUE DATE: 1.9 Ianuary 201.6

Name and signature of an authorised person of the Competent Authority of Australia:

Sign ed : . . . . . .. . . . .. .. . . .. .. , . ,. . , . .. . ,, ,. , . ..obert Prestri

Manufacturing Quality Branch

This certificate is valid onlyif the security provisions Iblue and grey curved dotted lines on the bottom half oreach pagej are visibleThis certificate remains valid onlyif re-inspections are conducted when scheduled by the Therapeutic Goods AdministrationThe authenticity of this certificate may be verified with the Therapeutic Goods Administration as the issuing authority

PO Box 100 Waden ACT 2606 ABN 40 939406804

Info@19a gov. au0262328444 0262328605 TGA^;:;^^^^:;^Page I of 2

Certificate of GMP Compliance of a Manufacti. Irer

of Active Pharmaceutical Ingredients (APIS)

Australian Government

Department of HealthTherapeutic Goods Administration

MANUFACTURING OPERATIONS

This certificate covers the following steps in the manufacture of APIS as therapeutic goods at themanufacturing site address specified above.

Manu, acturing Type

Active Pharmaceutical

Ingredient manufacture

Certificate Number:

M1-2016-CE-00278-I

ACTIVE SUBSTANCES MANUFACTURED

Carved1101, Citalopram hydrobromide, On dansetron hydrochloride dihydrate, On dansetron,Duloxetine hydrochloride, ESCitalopram oxalate, Rivastigmine hydrogen tartrate andRivastigmine (vivantigmine base).

Sterility

Non Sterile

Dosage Form

API - Not Defined

Product Category

Registered TherapeuticGood

Name and signature of an authorised person of the Competent Authority of Australia:

Si ned: """" ' ' ' "' ' "' """""'obert Prestri e

Manufacturing Quality Branch

This certificate is valid onlyif the security provisions Iblue and grey curved dotted lines on the bottom half oreach pagej are visible.This certificate remains valid onlyif re inspections are conducted when scheduled by the Therapeutic Goods Administration.The authenticity of this certificate may be verified with the Therapeutic Goods Administration as the issuing authority.

Manulacturing Step

Active material manufacture

PO Box 100 Waden ACT 2606 ABN 40 939406804

info@tga gov au ^^^u0262328444 0262328605 TGA^;I:!^^;;^;,Page 2 of 2