Sources, quality and prices of active pharmaceutical ingredients of antiretroviral drugs

Post on 02-Mar-2022

7 views 0 download

Transcript of Sources, quality and prices of active pharmaceutical ingredients of antiretroviral drugs

SOURCES, QUALITY AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS OF

ANTIRETROVIRAL DRUGS

Results of a 2012 WHO survey

WHO Library Cataloguing-in-Publication Data

Sources, quality and prices of active pharmaceutical ingredients of antiretroviral drugs: results of a 2012 WHO survey.

1.Anti-HIV agents - standards. 2.Anti-HIV agents - economics. 3.Anti-retroviral agents - economics. 4.Drug costs. 5.Drug industry. 6.Data collection. I.World Health Organization.

ISBN 978 92 4 150377 8 (NLM classification: QV 268.5)

© World Health Organization 2012

All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html).

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

1

!

SOURCES,!QUALITY!AND!PRICES!OF!ACTIVE!PHARMACEUTICAL!INGREDIENTS!OF!ANTIRETROVIRAL!DRUGS!

Results!of!a!2012!WHO!survey!!

This%document%reports%on%a%survey%by%WHO%on%the%market%for%Active%Pharmaceutical%Ingredients%(API)%of%antiretroviral%(ARV)%drugs,% conducted% in% the% first% quarter% of% 2012.% The% information% requested% from% the% manufacturers% included% whether% they%produce% ARV% APIs,% what% is% their% API% price,% the% regulatory% status% and% pharmacopoeia% standard% of% their% products,% their%production% capacity,% storage% conditions% and% whether% they% have% an% APIMF% (API% Master% File)% available% or% not.% % Thirteen%manufacturers%responded.% %The% information% they%provided% is% shown% in% the% tables%below,%which%are%arranged% in%alphabetical%order%by% the% International%NonLproprietary%Name%of% their%products.%The%manufacturers%contact% information%can%be% found% in%Appendix%1.%

%Disclaimer:%All# data#and# information#available# in# the#Sources,#Quality#and#Prices#of#Active#Pharmaceutical# Ingredients# (API)# for#antiretroviral#medicines#has#been#provided#by#the#manufacturers#and#has#not#been#verified.#WHO#makes#no#representations#or#warranties,#either#expressed#or#

implied,#as#to#their#accuracy,#completeness#or#fitness#for#a#particular#purpose.#Neither#does#WHO#accept#any#responsibility#or#liability#with#regard#to#

the#reliance#on,#or#use#of,#such#data#and#information.#%

WHO#has#made#every#effort#to#ensure#the#accuracy#of#the#information#presented,#but#the#readers#should#realize#that#manufacturing#and#production#

capacity#are#a#highly#dynamic#area,#and#that#data#can#therefore#never#be#complete.#The#data#and#information#contained#herein#are#being#provided#

as#is.##

The#mention# of# specific# companies# or# of# certain#manufacturers’# products# does# not# imply# that# they# are# endorsed# or# recommended# by#WHO,# in#

preference#to#others#of#a#similar#nature#that#are#not#mentioned.##However,#some#products#on#this#list#have#been#preIqualified#for#procurement#by#the#

WHO#preIqualification# pilot# project,# and# have# been# endorsed# by# the#Organization.# # This# is# the# only# endorsement#WHO#gives# to# pharmaceutical#

products.##The#list#of#WHO#pre#qualified#API#is#available#at#http://mednet3.who.int/prequal/.#####

Errors# or# omissions# excepted,# the# names# of# proprietary# products# are# distinguished# by# initial# capital# letters.# The# designations# employed# and# the#

presentation#of#the#material#in#this#report,#including#tables,#do#not#imply#the#expression#of#any#opinion#whatsoever#on#the#part#of#WHO#concerning#

the#legal#status#of#any#country,#territory,#city#or#area#or#of#its#authorities,#or#concerning#the#delimitation#of#its#frontiers#or#boundaries.#

2

A!B!A!C!A!V!I!R!!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 700%

Unit%11,%Survey%Nos.%61L66,%Industrial%

Development%Area,%Pydibhimavaram,%

Ranasthalam%Mandal,%Srikakulam%District,%Andhra%Pradesh.%

India,%USFDA% InLHouse%

Store%in%a%Well%closed%container%at%Controlled%Room%

Temperature%

24,000% Yes%

Cipla!Limited! 1,150% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Matrix!Laboratories!Ltd.!! 850% Unit%VIII% USFDA/WHO/India% USP% %% 30% Yes%

A!C!Y!C!L!O!V!I!R!!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Matrix!Laboratories!Ltd.!! 55% Unit%VII% USFDA% USP/BP% %% 200% Yes%

3

A!M!P!R!E!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

APIchem!Chemical!Technolgoy!Co.,Ltd!

9000%Rm%15%C202.No%300%

Chuantu%Rd.%Pudong%Area.%Shanghai%201202'%

No% in%House% %% 0.1% No%

A!T!A!Z!A!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

APIchem!Chemical!Technolgoy!Co.,Ltd!

1400%Rm%15%C202.No%300%

Chuantu%Rd.%Pudong%Area.%Shanghai%201202%China%

No%% in%House% %% 5% No%

Emcure!Pharmaceuticals!Ltd! 2000%Emcure%Pharmaceuticals%Limited,%Kurkumbh,%India%

USFDA% %% %% %% %%

Matrix!Laboratories!Ltd.!! 1400% Unit%%I% Filed% in%House% %% 6% Filed%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

L%% Shanghai% US% %% %% R&D% Tech%pack%

4

D!A!R!U!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

APIchem!Chemical!Technolgoy!Co.,Ltd!

9000%Rm%15%C202.No%300%

Chuantu%Rd.%Pudong%Area.%Shanghai%201202%China%

No% in%House% %% 0.1% No%

D!I!D!A!N!O!S!I!N!E!

Manufacturer!Company!Name!

API!Price!US$/kg!

Address!of!Production!Facility!!

Regulatory!authorities!that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!kg/Year!(per!API)!

APIMF!available!(Yes!/!No)!

Aurobindo!Pharma!Limited! 600%

Unit%11,Survey%Nos.%61L66,Industrial%

Development%Area,%Pydibhimavaram,Ranasthalam%Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% InLHouse%

Store%in%a%Well%closed%container%at%Controlled%Room%Temp.%

12,000% Yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

L%%% Shanghai% L% %% %% Campaign% Tech%pack%

5

E!F!A!V!I!R!E!N!Z!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Arch!Pharmalabs!Ltd.! 250%%

1)%Arch%Pharmalabs%Limited%

%Survey%No.%10,%Plot%No.%3L72,%Gaddapotharam,%

Jinnaram%Mandal,%Medak%Dt.%502%319%(A.P)%India%

India%%local%FDA%% USP%

Store%in%well%closed%

container.%%Store%at%25°C,%

excursions%permitted%between%15°C%and%30°C%

5%tonnes/10%tonnes%per%campaign.%Lead%time%of%3%months%

for%ordering.%

yes%

Aurobindo!Pharma!Limited! 200%

Unit%8,%Survey%No.13,%Gaddapotharam%Village,%Jinnaram%Mandal,Medak%

District,%%Andhra%Pradesh.%

India,%USFDA% InLHouse%

20L25°C%%[controlled%room%

temperature%in%a%well%closed%

container]%

120,000% Yes%

Cipla!Limited! 600% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Emcure!Pharmaceuticals!Ltd!

450%Emcure%Pharmaceuticals%Limited,%Kurkumbh,%India%

USFDA% %% %% %% %%

Matrix!Laboratories!Ltd.!! 325% Unit%VIII% WHO/India% in%House% %% 225% yes%

Matrix!Laboratories!Ltd.!! 450% Unit%VIII% USFDA/WHO/India% in%House% %% 36% yes%Matrix!Laboratories!Ltd.!! 450% Unit%III% USFDA/WHO/India% in%House% %% % yes%Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% US% IP% %% 150000% Yes%

6

E!M!T!R!I!C!I!T!A!B!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited!

420%

Unit%11,Survey%Nos.%61L66,Industrial%Development%

Area,%Pydibhimavaram,Ranasthalam%Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% InLHouse%

Store%in%a%Well%closed%container%at%Controlled%Room%Temp.%

20,000% Yes%

Cipla!Limited! 1,100% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Emcure!Pharmaceuticals!Ltd!

%%Emcure%Pharmaceuticals%Limited,%Kurkumbh,%India%

USFDA% %% %% %% %%

Lonzeal!Pharmaceuticals!Co.,!Ltd.!

500%

No.%16%West%Ring%Road,%Shenze,%Shijiazhuang%City,%Hebei%Province%052560%

China%

N/A% Ph.Int.,%USP% %% 20,000% Yes%

Matrix!Laboratories!Ltd.!! 650% Unit%III% USFDA/India% in%House% %% 24% Yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% US% %% %% Campaign% Yes%

E!T!R!A!V!I!R!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

EASYBUYER!LTD!(Shanghai!Renyoung!Pharmaceutical!

Co.,!Ltd.)!16500% CHINA%% Not%available% Not%available% RT% 10kg/year%

Not%available%

7

I!N!D!I!N!A!V!I!R!!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Matrix!Laboratories!Ltd.!! 450% %% %% %% %% %% No%

L!A!M!I!V!U!D!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Anhui!Biochem!United!Pharm!Co.!Ltd.!

145%No%6%Zone%B,%Industrial%

Park,%Taihe,%Anhui(236604),China.%

GMP%certificate%LLChina%

USP%/%BP%

Preserve%in%wellLclosed,%

lightLresistant%containers.%Store%at%room%

temperature.%

200% YES%

Arch!Pharmalabs!Ltd.! %%%%%250%

1)%Vitalife%Laboratories(%A%DIVN%of%Archpharmalabs%

Limited),%Gurgaon,Haryana,India%

%Village%Patheri,Bilaspur.%Tauru%Road,%Dist.%Gurgaon,%Haryana%122001,india%

USFDA%inspected% USP%

Preserve%in%wellLclosed,%

lightLresistant%containers.%%Store%at%room%

temperature%

5%tonnes/10%tonnes%per%campaign.%Lead%time%of%3%months%

for%ordering.%

yes%

8

L!A!M!I!V!U!D!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Arch!Pharmalabs!Ltd.! 250% 2)%Arch%Pharmalabs%Limited%%Survey%No.%10,%Plot%No.%3L72,%Gaddapotharam,%Jinnaram%Mandal,%Medak%Dt.%502%319%(A.P)%India%

India%Local%FDA%compliance%

USP% Preserve%in%wellLclosed,%lightLresistant%containers.%%Store%at%room%temperature%

5%tonnes/10%tonnes%per%campaign.%Lead%time%of%3%months%for%ordering.%

yes%

Aurobindo!Pharma!Limited! 190% Unit%1,%Survey%Nos.388%&%389,Borapatla%Village,Hathnoora%Mandal,Medak%District,%Andhra%Pradesh.%

India,%USFDA% USP% 15L30°C%[controlled%room%temperature%in%a%well%closed%container]%

114,000% Yes%

Cipla!Limited! 250% Cipla%Kurkumbh% USLFDA,%TGA,%WHOLGeneva%

USP,%EP,%IP% %% %% Yes%

Lonzeal!Pharmaceuticals!Co.,!Ltd.!

150% No.%16%West%Ring%Road,%Shenze,%Shijiazhuang%City,%Hebei%Province%052560%China%

China%SFDA,%India%DCGI,%Brazil%ANVISA,%South%Africa%MCC,%WHO%(APIMF%approved,%inspection%scheduled%in%May%2012)%

USP,%EP,%Ph.Int.,%India%Ph.,%China%Ph.%

%% 100,000% Yes%

9

L!A!M!I!V!U!D!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Matrix!Laboratories!Ltd.!! 220% Unit%%I% USFDA/WHO/India% USP% %% 132% Yes%

Matrix!Laboratories!Ltd.!! 220% Unit%II%(Astrix)% USFDA/WHO/India% USP% %% 108% Yes%

Matrix!Laboratories!Ltd.!! 220% Smruti%(CMU)% Not%filed%yet% USP% %% 60% No%

Matrix!Laboratories!Ltd.!! 220% Mchem% Filed%with%WHO% USP% %% 60% Filed%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

L%% Shanghai% WHO/%US% USP% %% 150000% Yes%

L!O!P!I!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capactiy!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 800%

Unit%11,Survey%Nos.%61L66,Industrial%Development%

Area,%Pydibhimavaram,Ranasthalam%Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% InLHouse%

Store%in%an%airtight%

container,%at%controlled%room%

temperature.%

24,000% Yes%

Matrix!Laboratories!Ltd.!! 1100% Unit%%I% USFDA/WHO/India% In%House% %% 36% yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

L% Shanghai% US% %% %% Campaign% Tech%pack%

10

NEVIRAPINE!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capactiy!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited!

200%

Unit%11,Survey%Nos.%61L66,Industrial%Development%

Area,%Pydibhimavaram,Ranasthalam%

Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% USP%

Store%in%a%Well%closed%container%at%Controlled%Room%

Temperature%

120,000% Yes%

Aurobindo!Pharma!Limited!

200%

Unit%1,%Survey%Nos.388%&%389,Borapatla%

Village,Hathnoora%Mandal,Medak%District,%

Andhra%Pradesh.%

India,%USFDA% USP%

15L30°C%[controlled%room%

temperature%in%a%well%closed%

container]%

5,000% Yes%

Boehringer!Ingelheim!GmbH!&!Co.!KG!

1400!!

Boehringer%Ingelheim%Chemicals%INC.,%2820%North%Normandy%Drive,%Petersburg%

(VA)%23805,%USA%

LFDA%(USA)%1.%Nevirapine%anhydrous:%USP,%EP,%BP%

no%storage%condition%required%

>%25000!

No%DMF%or%CEP%is%

available%for%Nevirapine%anhydrous%

or%Nevirapine%hemihydrate%

11

NEVIRAPINE!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capactiy!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Boehringer!Ingelheim!GmbH!&!Co.!KG!

1400!!

Boehringer%Ingelheim%Chemicals%INC.,%2820%North%Normandy%Drive,%Petersburg%(VA)%23805,%

USA%

LCompetent%authority%of%RheinlandLPfalz,%

Germany%%“Landesamt%für%Jugend,%Soziales%und%Versorgung”%

2.%Nevirapine%hemihydrate:%

USP%

no%storage%condition%required%

>%25%000!

No%DMF%or%CEP%is%

available%for%Nevirapine%anhydrous%

or%Nevirapine%hemihydrate%

Cipla!Limited! 250% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Matrix!Laboratories!Ltd.!! 220% Unit%%I% USFDA/WHO/India% USP% %% 60% Yes%

Matrix!Laboratories!Ltd.!! 220% Unit%II%(Astrix)% USFDA/WHO/India% %% %% 144% yes%

Shandong!Xinhua!Pharmaceutical!Co.,!Ltd!

275% Zibo,Shandong,%China% China%GMP%National%standard%%

%% 5% No%%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% WHO/%US% USP% %% 120000% Yes%

12

R!I!T!O!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 1100%

Unit%1,%Survey%Nos.388%&%389,Borapatla%

Village,Hathnoora%Mandal,Medak%District,%

Andhra%Pradesh.%

India,%USFDA% USP%

5L30°C%[controlled%room%

temperature%in%a%well%closed%

container]%

12,000% Yes%

Emcure!Pharmaceuticals!Ltd!

%%Emcure%Pharmaceuticals%Limited,%Kurkumbh,%India%

USFDA% %% %% ! %%

Matrix!Laboratories!Ltd.! 1250% Unit%VIII% USFDA/WHO/India% USP% % 12% Yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% US% USP% %% Campaign% Yes%

S!A!Q!U!I!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

L%% Shanghai% L% %% %% Campaign% L%

13

S!T!A!V!U!D!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 400%

Unit%1,%Survey%Nos.388%&%389,Borapatla%

Village,Hathnoora%Mandal,Medak%District,%

Andhra%Pradesh.%

India,%USFDA% USP%

15L30°C%%[controlled%room%

temperature%in%a%well%closed%

container]%

10,000% Yes%

Cipla!Limited! 510% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Matrix!Laboratories!Ltd.!! 380% Unit%II%(Astrix)% USFDA/WHO/India% USP% %% 40% Yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% WHO/%US% USP% %% 30000% Yes%

T!E!N!O!F!O!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Cipla!Limited! 630% Cipla%Kurkumbh%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Emcure!Pharmaceuticals!Ltd! %%Emcure%Pharmaceuticals%Limited,%Kurkumbh,%India%

USFDA% %% %% %% %%

Matrix!Laboratories!Ltd.!! 725% Unit%VIII% USFDA/India% in%House% %% 72% Yes%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% US% %% %% Campaign% Yes%

14

T!E!N!O!F!O!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 385%

Unit%11,Survey%Nos.%61L66,Industrial%Development%

Area,%Pydibhimavaram,Ranasthala

m%Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% InLHouse%

Store%in%a%wellLclosed%container,%at%

a%temperature%2%to%8°C%%

72,000% Yes%

T!I!P!R!A!N!A!V!I!R!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Boehringer!Ingelheim!GmbH!&!Co.!KG!

!

Boehringer%Ingelheim%Pharma%GmbH%&%Co.%KG,%Binger%Strasse%173,%55216%Ingelheim%am%Rhein,%

Germany%

GMP%compliance%has%been%certified%by%the%competent%authority%of%RheinlandLPfalz,%

Germany%%“%Landesamt%für%Jugend,%Soziales%und%Versorgung”%

Successful%confirmation%of%the%GMP%status%by%FDA%(USA),%KFDA%(South%Korea),%MOH%Turkey%(Turkey),%ANVISA%(Brazil),%NAFDAC%

(Nigeria)%and%Uganda%due%to%cGMP%inspections%

L%Store%below%30°C.%

!No%DMF%

available%for%Tipranavir%

15

%Z!I!D!O!V!U!D!I!N!E!

Manufacturer!Company!Name!

API!Price!!US$/kg!

Address!of!!Production!Facility!!

Regulatory!authorities!!

that!certified!GMP!compliance!

Pharmacopeia!Standard!!

Storage!Conditions!

Production!Capacity!!kg/Year!(per!API)!

APIMF!available!!(Yes!/!No)!

Aurobindo!Pharma!Limited! 270%

Unit%11,Survey%Nos.%61L66,Industrial%Development%

Area,%Pydibhimavaram,Ranasthalam%Mandal,Srikakulam%District,Andhra%Pradesh.%

India,%USFDA% USP%

15L30°C%%[Store%in%an%airtight%

container,%at%controlled%room%temp.]%

180,000% Yes%

Cipla!Limited! 425% Cipla%Banglore%USLFDA,%TGA,%WHOL

Geneva%USP,%EP,%IP% %% %% Yes%

Matrix!Laboratories!Ltd.!! 340% Unit%II%(Astrix)% USFDA/WHO/India% USP% %% 30% Yes%

Matrix!Laboratories!Ltd.!! 340% Unit%VIII% USFDA/WHO/India% USP% %% 20% Yes%

Matrix!Laboratories!Ltd.!! 340% Smruti%(CMU)% WHO/India% USP% %% 42% Yes%

Matrix!Laboratories!Ltd.!! 340% Mchem% Filed%for%WHO% USP% %% 72% Filed%

Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!

%% Shanghai% WHO/%US% USP% %% 250000% Yes%

16

Appendix!1:!!Contact!Information!!

Manufacturers!that!participated!in!this!survey!in!alphabetical!order%!Abbott!Laboratories%DL6MQ;%AP34L3,%200%Abbott%Park%Rd,%Abbott%Park,%IL%60064,%USA%%Contact:%Robert%Dintruff%(Director)%%Tel:%1L847L938L7945%ELmail:%Rob.Dintruff@abbott.com%Website:%http://www.abbott.com/index.htm%%!Anhui!Biochem!United!Pharm!Co.!Ltd.%No.%30%Hongfeng%Road,%%HiLTech%Development%Zone,%%Hefei%(230088),%%People's%Republic%of%%China%%Contact:%Li%Zhixin%(Manager)%%Tel:%+86%(551)%5167062%Fax:%+86%(551)%5171062%ELmail:%%lz@bcpharm.com%Website:%http://www.bcpharm.com/en/info.asp?base_id=21%%!APIchem!Chemical!Technolgoy!Co.,!Ltd%Rm%15%C202.No%300%Chuantu%Rd.%Pudong%Area.%Shanghai%201202%China%%Contact:%Kyree%Fu%(General%Manager)%%Tel:%86(21)31390712,51969752%Fax:%86(21)51969751%ELmail:%info@apichem.net;%apichem@gmail.com%Website:%http://www.apichem.net%%%

17

!Arch!Pharmalabs!Ltd.%541LA,%Arch%House,%Marol%Maroshi%Road,Andheri%(E),%Mumbai,%India%%%Contact:%1)%Sudhir%Nagar%(President%Marketing);%2)%Prabhakar%Duwuri%(Vice%President%Marketing)%%Tel:%00%91L22L33089200%Fax:%00%91L22L2847%1234%ELmail%1:%sudhir.nagar@arch%ELmail%2:%prabhakar.duwuri@archpharmalabs.com%Website:%http://www.archpharmalabs.com/products/apisLproducts.asp%%%Aurobindo!Pharma!Limited,%Exports%&%ARV's,%Auro%House,%313,%Bachupally,%Quthubullapur%(M),%RR%Dist.,%500%072%(A.P),%India%%%%Contact:%Sharadd%Jain%(Associate%Vice%President)%%Tel:%00%91%(40)%2374%1080%18%Fax:%00%91%(40)%374%6833%ELmail:%jainsharadd@aurobindo.com%Website:%http://www.aurobindo.com/api.htm%%%Boehringer!Ingelheim!GmbH!&!Co.!KG%Pharma%Chemicals,%%Binger%Strasse%173,%%55216%Ingelheim%am%Rhein%%%Contact:%Dennis%Seagle%%Tel:%49%%6132%77%0%Fax:%49%6132%72%0%ELmail:%dennis.seagle@boehringerLingelheim.com%Website:%http://www.boehringerLingelheim.com/%%%

18

!Cipla!Limited%289%Belasis%Road,%%Mumbai%Central,%%547649%Mumbai,%%India%%%Contact:%1)%Rahul%Lande%(Export%Manager);%2)%Rohan%Sabnis%(Export%Executive)%%Tel:%00%91%(22)%2308%2891%Fax:%00%91%(22)%2307%0013%ELmail%1:%Rahul.Lande@cipla.com%ELmail%2:%Rohan.Sabnis@cipla.com%Website:%http://www.cipla.com/%%!EASYBUYER!LTD!(Shanghai!Renyoung!Pharmaceutical!Co.,!Ltd.)%RM407,%Bldg%10%HiLShanghai%Center,%No.990%Dalian%Rd,Shanghai,%China%%Contact:%Willa%Young%(Director%Manager);%(Secondary%point%of%Contact:%Teresa%Hu)%%Tel:%0086L21L35015877%Fax:0086L21L35010877%ELmail:%info@renyoung.com;%(Secondary%point%of%Contact:%teresa@renyoung.com)%Website:%http://www.renyoung.com%%%Emcure!Pharmaceuticals!Ltd%Survey%No.%255/2,%Phase%1,%MIDC.Hinjwadi,%%Pune%L%411%057,%India%%Contact:%Devbalaji%Utharadhi%Balaji%(Director)%%Tel:%+91%20%39821004%/%3982%1000%%%Fax:%+91%20%39821030%Mob:%+91%98901%99044%ELmail:%BalajiUD@emcure.co.in%Website:%http://www.emcure.co.in%%%

19

!Lonzeal!Pharmaceuticals!Co.,!Ltd.!Rm%1109%Bldg%3%Splendid%International%Plaza,%No.1%Tenth%St.%%Shangdi,%%Haidian%Beijing%100085,%P.R.%China%%%Contact:%Dr.%Jing%Zhang%(Marketing%Director)%%Tel:%+86L10L82176280%ext.%106%Fax:%+86L10L82176289%Mobile:%+86L13810252300%ELmail:%jing@lonzeal.com%Website:%www.lonzeal.com%%%%Matrix!Laboratories!Ltd.!!1L1L151/1%Sairam%Towers,%%Alexander%Road,%%Secunderabad%L%500%003,%India%%Contact:%Mr.%Anirudh%Deshpande%(Senior%Vice%President)%%Tel:%0091%40%5537%7427%Mobile:%0091%98481%13220%Fax:%00%91%40%5533%6401%ELmail:%Anirudh.Deshpande@matrixlabsindia.com%%%%Shandong!Xinhua!Pharmaceutical!Co.,Ltd.!%No.14,%Dongyi%Road,%Zibo,%%China.%%Contact:%Peng%Xinwen%(Project%Manager%of%international%business%dept.)%%Tel:%+86L533L2196082%Fax:+86L533L2183499%ELmail:%pengxinwen@xhzy.com%Website:%Http://www.xhzy.com/en%%%

20

!Shanghai!Desano!Chemical!Pharmaceutical!Co.,!Ltd.!!No.1479%Zhangheng%Road,%%Zhangjiang%HighLtech%Park,%%Shanghai%201203,%People's%Republic%of%China%%Contact:%Mr%Kenny%Cheung%(Vice%President)%%Tel:%+86%(21)%5132%3300%Fax:%+86%(21)%5132%3311%ELmail:%info@desano.com;%Kenny.cheung@desano.com%%Website:%www.desano.com%%%

ISBN 978 92 4 150377 8

Sources, quality and prices of active pharmaceutical ingredients of antiretroviral drugs:

Results of a 2012 WHO survey