INN API specification number

Abacavir
FS/AABS/03 version 2.0
(sulfate)

Abacavir
STP/FPR/ABC/001/00
(sulfate)

Amodiaquine
M-I/DS/IH/SP/AMQ rev 02
(hydrochloride)
Amodiaquine
TS/BPC/Q5/CS/DMF
(hydrochloride)

Artemether M-1/DS/Ph.Int/SP/ARM-02

Artemether M-1/DS/Ph.Int./SP/AMR [Rev. No. 07]

Artemether SP/FP/71, Revision: 02

Artemether TS/BPC/AR2/CS/DMF No. 01,

Artemether STP/FPR/ARM/001/03

Artemether Q1-08003-04

Artemether SOP-B-QC-133-03

Artemether SMP-QA-030050-04

Artemether GAPS 040/1

Artesunate M-1/DS/Ph.Int/SP/ARS-07

Artesunate BDC/FP/R1 (unmicronised) and BBF/FP/R2 (micronised)

Artesunate TS/BPC/AS6/CS/DMF, Issue 1

Artesunate GAPS 032/3

Artesunate STP/FPR/ART/001/03

Atazanavir
STP/FPR/ATZ/007/01
(sulfate)

Capreomycin
H3-QS-10090 (10)
(sulfate)

Capreomycin
Version 04
(sulfate, sterile)

Cycloserine SPEC-SCQE-508 Rev.No. 04

Cycloserine Rev. No (08) 2013-06-01

Didanosine STP/FPR/DDI/002/02

Dihydroartemisin
M-1/DS/Ph.Int./SP/DHA, Rev No. 09
in

Dihydroartemisin
STP/FPR/DHY/001/04
in

Dihydroartemisin
SP-FP-004, Version 2
in

Efavirenz SOP-B-QC-170-11

Efavirenz CQA/STP/API/020/01
Efavirenz FS/AELT-301/02 version 9.0

Emtricitabine FS/AECB/02 version 6.0

Emtricitabine SOP-B-QC-165-07

Emtricitabine STP/FPR/EMB/004/04

Ethambutol
API 303622-01-01
(hydrochloride)

Ethambutol
FPSPUS086 revision number 04
(hydrochloride)

Ethinylestradiol QZ01-STP01-040-3

Ethionamide QC-20-A1190EPW, version 12

Isoniazid SP/FP/73 Rev 00

Isoniazid SP-API-061-05

Kanamycin (acid
SOP.02.3102.003
sulfate) - sterile

Kanamycin
(sulfate) - non SOP.02.3101.002
sterile

Lamivudine SOP-B-QC-108-02

Lamivudine FS/ALMD/02 Version 4.0

Lamivudine Specification version 3

Lamivudine CQA/STP/API/006/00

Levofloxacin QS-ZF00W-04

Levofloxacin D-QA533-R03

Levonorgestrel QZ01-STP01-005-5

Lopinavir CQA/STP/API/008/01

Lopinavir FPS/F1016C/03

Lumefantrine M-1/DS/Ph.Int./SP/LUF, Rev 09

Lumefantrine BBZ/FP/R5

Lumefantrine SP/FP/59 Rev 04

Lumefantrine TS/BPC/LU/CS/DMF Issue 02 Rev 00

Lumefantrine STP/LMF/FPR/002/05

Lumefantrine SOP-B-QC-121-08

Lumefantrine FPSPPI037, Revision 07

Mebendazole QS-0005.01-L
Medroxyprogest
SOP-QC-1083 Rel 04
erone acetate

Mifepristone Non-micronized-QZ01-STP01-023-5

Mifepristone Micronized-QZ01-STP01-049-3

Misoprostol
Dispersion Misoprostol Dispersion WHO APIMF226-0 version 1.0
(1:100 in HPMC)

Moxifloxacin
H3-QS-10135 (04)
(hydrochloride)

Nevirapine FT/ANVP/02

Nevirapine CQA/STP/API/017/00

Nevirapine SOP-B-QC-116-14

Oseltamivir
STP/FPR/OST/002/03
(phosphate)

Piperaquine
M-1/DS/IH/SP/PPQ/05
(phosphate)

Piperaquine
STP/PQP/FPR/001/04
(phosphate)

Piperaquine
A1-QC3401-06
(phosphate)

Protionamide QC-20-A1320BPD-W Version 11

Pyrazinamide SP/FP/12 rev 13

Pyrazinamide API 300942-02-07

Pyronaridine
STP/FPR/PYT/001/07
(phosphate)

Rifampicin API 300267-04-03

Rifampicin Compacted - SRF/M/QC/204, v01

Rifampicin Micronised - SRF/M/QC/206, v01

Rifampicin Milled - SRF/M/QC/186, v02

Rifampicin Non-compacted - SRF/M/QC/205, v01

Rifampicin QB08-130, ed. 07

Ritonavir STP/FPR/RIV/001/06

Ritonavir STP/FPR/RIV/005/03

Ritonavir SOP-B-QC-135-08

Streptomycin
PRS-S-009, Version: 05
(sulfate) - Sterile
Tenofovir
disoproxil FS/ATDF/02 version 4
(fumarate)

Tenofovir
disoproxil FS/BTDF/02 version
(fumarate)

Tenofovir
disoproxil M-1/DS/IH/SP/TPF, revision 00
(fumarate)

Tenofovir
disoproxil CQA/STP/API/014/01
(fumarate)

Tenofovir
disoproxil SOP-B-QC-139-07
(fumarate)

Zidovudine QS-AT00W-01

Zidovudine BEQ/FP/R4

Zidovudine SOP-B-QC-100-10 & SOP-B-QC-218-06

Zidovudine CQA/STP/API/005/07

Zinc (sulfate) Version number 059/097

Packaging Storage Conditions

Do not store above

Double transparent LDPE bag placed in a HDPE
30°C, protect from
container
moisture
Do not store above
White LDPE bag closed and placed in a second PE
30°C, protect from
bag which is black closed and placed in HDPE
moisture, protect from
drums
light
Colourless LDPE bag inserted in a black colored (Shelf life) Do not store
LDPE bag, placed in HDPE drum. above 30°C
Double sealed clear Polyethylene bags (LDPE) in Do not store above
fibre/HMHDPE drum 30°C
Tied double LDPE bags, housed within either fibre or Do not store above
HDPE drums. 30°C

Tied double LDPE bags; primary is white & (Shelf life) Do not store
secondary is black, housed within HDPE drums above 25°C

Store in a refrigerator
Twin HMHDPE bags placed in HDPE drums (2 °C to 8 °C), protect
from light
Inner bag: Clear LDPE bag (Nitrogen purging); Do not store above
Middle bag: Black LDPE bag; Outer bag: 25°C, protect from
PET/Aluminium/Pet/Poly Bag in either Fibre Drums moisture, protect from
or HMHDPE drums light

Inner white LDPE bag (fastened), placed in an LDPE

black polythene bag and heat-sealed.The bag is Store in a refrigerator
placed in a Triple laminated aluminum bag and heat- (2 °C to 8 °C)
sealed. The bag is transferred into HDPE drums

Store in a refrigerator
Twin polyethylene bags placed in steel drums
(2 °C to 8 °C)
Double polythene bags tied separately with a LDPE
Store in a refrigerator
fastener enclosed in aluminium foil bag (heat-
(2 °C to 8 °C), protect
sealed), then in a fibre drum. The top lid is sealed
from light
with tape.

Primary packaging consists of two layers of

transparent LDPE bags. Secondary packaging is Store in a refrigerator
black LDPE bag and then packed in a (2 °C to 8 °C)
fibreboard/cardboard drum.
Artemether is packaged in polyaluvel type bag. The Store in a refrigerator
bags are placed into fibre or plastic drum or (2 °C to 8 °C), protect
cardboard boxes from light
Do not store above
Double food grade polyethylene bags (LDPE), the
25°C, protect from
outer bag being black. The bags are tied with plastic
moisture, protect from
strips and placed in either HDPE or fiber drums.
light
Food grade white HM HDPE bags followed by black Store in a refrigerator
HM HDPE bags in HDPE drums (2 °C to 8 °C)
Inner bag: clear LDPE with nitrogen purging; Middle:
Do not store above
black LDPE bag with silica gel; Outer:
25°C
Aluminium/Pet/Poly bagSecondary: fibre drums
The primary package is a commercial 3-layer
aluminium foil polyaluvel bag, packed under nitrogen Do not store above
and stored in fibre drum containers or cardboard 30°C, protect from light
boxes.
Artesunate is packed in inner white low-density
Store in a refrigerator
polyethylene (LDPE) bag, then in an LDPE black
(2 °C to 8 °C), protect
polythene bag and heat-sealed, then placed in a
from moisture, protect
Triple laminated aluminium bag and heat sealed, in
from light
HDPE drums.

White PE inner bag, placed inside black PE bag, with

silica gel sachet placed between inner and outer bag. Do not store above
The bags are placed within HDPE drums sealed with 30°C
rubber gasket and locking ring.

Store in a refrigerator
100 L HyClone HyQ ® CX5-14 bag in HDPE
(2 °C to 8 °C), protect
HyClone drum
from light
Do not store above
Aluminium tin with inner aluminium cap covered with
25°C, protect from
rubber ring and then outer aluminium cap. Two tins
moisture, protect from
are placed in one carton.
light

Translucent polyethylene bag purged with nitrogen

and closed with pilfer proof seal. The translucent
polyethylene bag is covered with aluminium foil bag (Shelf life) Do not store
(triple laminated bag), a silica gel sachet is kept in above 25°C, protect
between two bags, purged with nitrogen and heat from moisture, protect
sealed. The bags are placed in a metal drum, silica from light
gel is placed in between metal drum and aluminium
foil bag (triple laminated bag)

Polyethylene vinyl bag tied with cable tie and Do not store above
packaged in an aluminium bag with silica gel, then 30°C, protect from
placed in a PE drum. moisture

White PE bags (primary) placed in black PE bags,

then triple laminated aluminium bag that is heat- (Shelf life) Do not store
sealed and in HDPE drums. Desiccants are placed above 30°C
between the PE bags and the triple laminated bag.

Primary: LDPE bag tied with a plastic strip in a black (Shelf life) Store in a
LDPE Secondary: HDPE drum sealed with a plastic refrigerator (2 °C to 8
seal. °C)

Inner white LDPE bag (fastened), placed in an LDPE Store in a refrigerator

black bag and heat-sealed. The tertiary bag is a triple (2 °C to 8 °C), protect
laminated aluminium bag and heat-sealed. The bags from moisture, protect
are then placed in HDPE drums. from light

Store in a refrigerator
Primary pack: PP/PET with aluminium/PE bags;
(2 °C to 8 °C), protect
Secondary pack: Plastic drum (with a screw cover)
from light

The primary package of Efavirenz consists of two

bags: inner bag and outer bag. The inner bag is
pharmaceutical grade low-density transparent Do not store above
polyethylene (LDPE) bag which is placed in the 30°C, protect from light
pharmaceutical grade LDPE bag (outer bag). In
drums

Efavirenz is first packed in white low-density

polyethylene (LDPE) bag, twist-tied, which is placed Do not store above
in a black polyethylene bag, twist-tied and put into 30°C, protect from light
HDPE drum, closed and sealed
Inner low-density transparent polyethylene (LDPE)
(Shelf life) Do not store
bag inside in a black LDPE bag twist-tied with a self-
above 25°C, protect
sealing plastic strip. The bags are housed in a HDPE
from light
drums.
Double transparent LDPE bags housed within HDPE Do not store above
drums 30°C

Emtricitabine is packed by two pharmaceutical grade

Do not store above
low density polyethylene(LDPE) bags, which are tied
30°C, protect from
separately with plastic slide fastener, and placed in
moisture, protect from
aluminum foil bag and closed with heat-seal; then
light
enclosed in a fibre drum.

Do not store above

PE bag (translucent) in black PE bag with HDPE
30°C, protect from
container (sealed)
moisture
Inner LDPE bag enclosed in a
HMHDPE/LDPE/LLDPE bag with silica sachet, outer Do not store above
aluminium bag, housed within Fibre or HMHDP 25°C
drums
Ethambutol hydrochloride is packed in LDPE Do not store above
transparent bag, secondary outer black LDPE bag 30°C, protect from
and triple laminated aluminum bags and HDPE moisture, protect from
drums. light

Ethinylestradiol is packed in double transparent low

density polyethylene bags then the loaded LDPE bag
Do not store above
is wrapped by heat-sealing laminated aluminium foil
30°C
bag. Finally the laminated aluminium foil bag is put in
a closed kraft paperboard drum.

Do not store above

Primary Packing material: Double polyethylene bags,
30°C, protect from
twist tied. Outer packaging: Fibre drum
moisture
HMHDPE translucent bag placed in HMHDPE black
Do not store above
bag and then either in a HDPE blue drum or in a fibre
30°C
drum
Primary packaging: LDPE bag; Secondary
Do not store above
packaging: Kraft paper bag; Tertiary packaging: Fibre
30°C, protect from light
drum
3# aluminium tin (7Kg each) with aluminium cap with
(Shelf life) Do not store
chlorinated butyl rubber seal ring in the inner part
above 25°C, protect
and then packed in carton (2 tins/carton or
from moisture
1tin/carton).

Packed into a system of two polyethylene bags and (Shelf life) Do not store
then packed in the aluminum tin, and finally packed above 25°C, protect
in the carton. from moisture

Inner packaging material: clear double

Do not store above
pharmaceutical grade low density polythylene bags
30°C, protect from light
separately tied; Outer packaging material: fibre drum

Transparent low density polyethylene bag with strip

seal, followed by secondary black low density Do not store above
polyethylene bag with strip seal, finally kept in high 30°C, protect from light
density polyethylene container.
 Do not store above
30°C, protect from
Double LDPE bags in all paper barrels
moisture, protect from
light
There are two alternative container systems: 1. PE
Do not store above
bag/black PE bag/HDPE drum or 2.PE bag/black PE
30°C
bag/cardboard box
Do not store above
Colorless transparent polyethylene plastic bags in 30°C, protect from
fibre drum moisture, protect from
light
In a colorless LDPE bag in a black LDPE bag placed Do not store above
in a cardboard drum 30°C
Do not store above
30°C, protect from
Double LDPE bag in aluminium drum
moisture, protect from
light

The material shall be packed in LDPE bag, twisted

and tied with plastic fastener under nitrogen
atmosphere. It is then inserted in I-IMLDPE bag with
two silica gel sachet and one molecular sieve sachet,
Do not store above
heat sealed. Both these bags are then put into the
30°C, protect from
outer triple laminated bag with one molecular sieve
moisture
sachet, heat sealed. Such bags are further packed in
FIDPE drums, closed with plastic lids having rubber
gasket followed by locking ring with metal seal and
labelled.

The primary packing material consists of transparent Do not store above

LDPE bag. The secondary packing material consists 30°C, protect from
of black polythene bag, triple laminated aluminium moisture, protect from
bag and fiber board drums. light

Tied double LDPE bags; primary is white & Do not store above
secondary is black, housed within HDPE drums 30°C

Food grade white HMHDPE bags enclosed in black Do not store above
HMHDPE bags and stored in HDPE drums. 30°C

Do not store above

Twin HMHDPE bags placed in HDPE drums
30°C
Twin LDPE bags placed in fibre drums or in Do not store above
HMHPDE drum 30°C
White LDPE bag, secured and tied with plastic
fastener. Placed within an HMLDPE bag and heat Do not store above
sealed.The tertiary packaging is a triple laminated 30°C, protect from
aluminium bag and heat-sealed. The bags are then moisture
placed in HDPE drums.
Two inner PE bags packed into a fibre drum tightly Do not store above
closed and sealed. 30°C

High density polyethylene HDPE drum lined with Do not store above
black low density polyethylene (LDPE) bag followed 30°C, protect from
by transparent low density polyethylene (LDPE) bag. moisture

Do not store above

Two layers of LDPE bags and fibre drum
30°C, protect from light
Packaging is constituted by three bags: inner
antistatic thermosealed coupled bag; a second
antistatic thermosealed coupled bag and a third bag Do not store above
of aluminum / nylon / polythene – dimension: 43 x 60 30°C
cm. The three bags are individually under vacuum
thermosealed.

Double transparent, low density polyethylene bags Do not store above

into aluminum drum. 30°C, protect from light

Double transparent, low density polyethylene bags

each heat-sealed, in a laminated aluminum bag, Do not store above
heat-sealed. Finally the aluminum bag is put in a 30°C, protect from light
closed kraft paperboard drum.

Either a conventional double additive free food grade

Store in a refrigerator
polythene bag or an additive free food grade
(2 °C to 8 °C), protect
continuous polythene liner. Both are sealed in
from moisture, protect
Polyester/ Aluminium/ Polythene laminate pouch
from light
then put it in a fibre board drum.

Do not store above

LDPE bag inside an aluminium foil bag, within a 30°C, protect from
sealed fibre drum. moisture, protect from
light
Do not store above
Dual LDPE bags enclosed within HDPE drums
30°C

1. LDPE semi-transparent polyethylene bag in black

polyethylene bag, in HDPE drums.2. LDPE semi- Do not store above
transparent polyethylene bag in black polyethylene 30°C
bag, in corrugated cardboard boxes.

Inner packaging: Double pharmaceutical grade Do not store above

polythene bag; Outer packaging: fibre drum 30°C
LDPE bag, which after nitrogen flushing, is inserted
Do not store above
into HMLDPE bag heat sealed. Both these bags are
30°C, protect from
then put into an outer triple laminated aluminium bag
moisture
and heat sealed.

(Shelf life) Do not store

Primary: LDPE bag tied with a plastic strip in a black
above 30°C, protect
LDPE Secondary: HDPE drum sealed with a plastic
from moisture, protect
seal
from light

White LDPE bag inside triple laminated aluminium

bag inside black cover along with two silica gel Do not store above
sachets, one molecular sieve and one O-buster 30°C, protect from
pack, heat sealed under vacuumed nitrogen. Then moisture, protect from
outer bag of triple laminated aluminium bag inside light
black cover and heat sealed, then in HDPE drum.

The product is primarily packed in a clear LDPE bag,

Do not store above
and into a black LDPE bag for light protected, sealed
30°C, protect from
with nylon buckle. The sealed PE bag is kept in a
moisture, protect from
fiber drum. The drum is sealed with ion ring and
light
labelled.
Primary packaging material: Double polyethylene Do not store above
bag.Outer packaging: Fibre drum 30°C
Dual HMHDPE translucent bags within a HPDE Do not store above
drum. 30°C
The material is packed in inner LDPE poly-bag which
Do not store above
is strap sealed and is placed in outer LDPE poly-bag
30°C, protect from
which is further heat sealed. It is then packed in
moisture
HMHDPE or fibre drums.

Primary packing: Low-density polyethylene (LDPE)

bag, securely twisted and tied with plastic fastener. (Shelf life) Do not store
Secondary packing: Black polythene bag and twisted above 25°C, protect
and tied with plastic fastener. Tertiary packing: from moisture
HDPE drum

LDPE inner back (under nitrogen) inside a triple

laminated aluminium bag with an antioxidant (Shelf life) Do not store
scavenger bag (between inner and outer bag) and above 25°C
kept in HM-HDPE containers
Polyethylene bag tied with a plastic strip seal in
Do not store above
sealed aluminium-polyethylene pouch (Alu pouch) in
25°C, protect from light
sealed HDPE drum
Polyethylene bag tied with a plastic strip seal in
Do not store above
sealed aluminium-polyethylene pouch (Alu pouch) in
25°C, protect from light
sealed HDPE drum
Polyethylene bag tied with a plastic strip seal in
Do not store above
sealed aluminium-polyethylene pouch (Alu pouch) in
25°C, protect from light
sealed HDPE drum
Polyethylene bag tied with a plastic strip seal in
Do not store above
sealed aluminium-polyethylene pouch (Alu pouch) in
25°C, protect from light
sealed HDPE drum

Rifampicin is packed in fiber drum having double

layer low-density double polyethylene bag. The inner
bag, in direct contact with the material, is transparent Do not store above
polyethylene bag. The outer bag is black 25°C, protect from light
polyethylene bag. The lid of the drum is closed by
clamp. The drum is finally sealed.

Ritonavir is packaged in (from inner layer to outer

Do not store above
layer): Antistatic LDPE bag under nitrogen, tied with
30°C, protect from
PP seal / antistatic black polyethylene bag / triple
moisture, protect from
polylaminated aluminium bag sealed with a hot
light
sealer / HDPE drum closed by a clamp.

Double PE bags (primary white PE bag, secondary

black PE bag) and outer aluminium bag. Product
packed under nitrogen atmosphere into inner PE Do not store above
bag, tied with PP seal and is further packed into an 30°C, protect from light
aluminium bag sealed with a heat seal which is kept
in a HDPE container.

The primary packaging comprises two low density

Do not store above
polyethylene (LDPE) bags sealed with a LDPE
30°C, protect from
closure. The secondary packaging is a brown fibre
moisture, protect from
drum closed with a lid and sealed with a hoop
light
closure.

(Shelf life) Do not store

Aluminum tin equipped with rubber ring and above 30°C, protect
aluminum covers, and put two tins into a carton from moisture, protect
from light
Double low density polyethylene transparent bag
Store in a refrigerator
(both with tag seal), followed by triple laminated
(2 °C to 8 °C), protect
sunlight barrier secondary pack, & finally it is packed
from light
in high density polyethylene container.

Transparent double low density polyethylene bag tied

with nylon strip seal, housed within a triple laminated Store in a refrigerator
sunlight barrier (TLSB) bag and is heat sealed and (2 °C to 8 °C)
finally kept in High Density polyethylene drums.

Store in a refrigerator
Colorless LDPE bag, inserted in black LDPE bag.
(2 °C to 8 °C), protect
LDPE bags are kept in HDPE drum.
from light

Antistatic white low-density polyethylene (LDPE) bag

(Shelf life) Do not store
under nitrogen atmosphere, placed in an another
above 25°C, protect
antistatic black polyethylene bag, sealed and placed
from moisture, protect
in to triple polylaminated aluminium bag and sealed,
from light
then placed in an HDPE drum.

Packed with two low density polythene bags, which Store in a refrigerator
are filled with nitrogen gas and tied separately with (2 °C to 8 °C), protect
LDPE fastener, then placed in aluminium foil bag and from moisture, protect
closed with heat-seal. from light

Primary packaging: double layer polyethylene plastic

Do not store above
bags; secondary packaging is a fiber drum closed
30°C, protect from light
with metallic lid and tightened with the metallic ring.

Do not store above

Double lined HMHDPE bags (inner white, outer 30°C, protect from
black) placed in HDPE containers. moisture, protect from
light
Double low density polythene bags, tied separately
Do not store above
and housed within brown fibre drums with tape-
30°C
sealed lids.
There are two alternative container systems: 1. PE
Do not store above
bag / black PE bag / HDPE drum or 2. PE bag /
30°C, protect from light
black PE bag / cardboard box

Single high density polyethylene (HD-PE) bags. The

bags are tightly closed using strong PE-cable Do not store above
binders. Secondary packaging: multilayer paper 30°C, protect from
bags, fibre drums, or cardboard boxes in different moisture
sizes.