Sources, quality and prices of active pharmaceutical ingredients of antiretroviral drugs
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: [email protected]).
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.
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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.#
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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:%[email protected]%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:%%[email protected]%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:%[email protected];%[email protected]%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:%[email protected]%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:%[email protected]%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:%[email protected]%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:%[email protected]%ELmail%2:%[email protected]%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:%[email protected];%(Secondary%point%of%Contact:%[email protected])%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:%[email protected]%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:%[email protected]%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:%[email protected]%%%%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:%[email protected]%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:%[email protected];%[email protected]%%Website:%www.desano.com%%%