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

23
SOURCES, QUALITY AND PRICES OF ACTIVE PHARMACEUTICAL INGREDIENTS OF ANTIRETROVIRAL DRUGS Results of a 2012 WHO survey

Upload: others

Post on 02-Mar-2022

5 views

Category:

Documents


0 download

TRANSCRIPT

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.

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:%[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%%%

ISBN 978 92 4 150377 8

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

Results of a 2012 WHO survey