Arquivo

RANBAXY LABORATORIES LIMITED INDIA

ORLISTAT DRUG MASTER FILE

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APPLICANTS PART (AP) Version Number 000 2013, April 29

F:\DRABULK\Som Parkash\Applicants Parts\Orlistai\Orlistar_AP_ Medley.docl

Ranbaxy Laboratories Limited Orlistat Applicants Part

ADMINISTRATIVE DATA Na me Chemical Name N ame and Address of a) Manufacturer of Active Substance Ranbaxy Laboratories Limited Industrial Area - 3 Dewas- 455 001 Madhya Pradesh India Ranbaxy Laboratories Limited Sarhaul, Sector-18 Gurgaon- 122 015 Haryana, India Applicants Part (AP) Orlistat N-Formyl-L-leucine, ester with (3S,4S)-3-hexyl4-[(2S)-2-hydroxytridecyl]-2-oxetanone

b) DMF Holder

D.MF Consists of

Ranbaxy Laboratories Limited, manufacturer of Orlistat, hereby confirms that any information regarding significant changes to the manufacturing process and specifications (including test methods) that are likely to alter the quality, purity and stability ofOrlistat active substance will be communicated to the applicant. Ali correspondence related to DMF should be addressed to the undersigned.

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Contact Person Dr. Som Parkash Associate Director Drug Regulatory Affairs Ranbaxy Laboratories Limited Sarhaul, Sector-18 Gurgaon- 122 015 Haryana India Phone No.: [phone] Fax No.: [phone] e mail: [e-mail]

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Ranbaxy Laboratories Limited Orlistat Applicants Part Module3

3.1:

TABLE OF CONTENTS Page

3.2 3.2.S 3.2.S.l 3.2.8.1.1 3.2.8.1.2 3.2.8.1.3 3.2.S.2 3.2.8.2.1 3.2.8.2.2 3.2.S.3 3.2.8.3.1 3.2.8.3.2 3.2.S.4 3.2.8.4.1 3.2.8.4.2 3.2.8.4.3 3.2.8.4.4 3.2.8.4.5 3.2.S.5 3.2.S.6 3.2.S.7 3.2.8.7.1. 3.2.8.7.2 3.2.8.7.3

BODYOFDATA DRUG SUBSTANCE GENERAL INFORMATION Nomenclature .................................................................................... 1-1 8tructure ............................................................................................ 1-1 General Properties