EVERY HOUSEHOLD HAS IT.....

WHAT IS IT?...

Paracetamol

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 CONSUMER’S DIGEST OF CAI JANUARY 2013

EVERY HOUSEHOLD HAS IT........WHAT IS IT ?…..

WT hat is it??
oday it is impossible to find
a household whose members
be used to treat fever in children if
their temperature is greater than
38.5 °C (101.3  °F). Paracetamol has
haven’t used the Paracetamol tablets a well-established role in pediatric
at one instance or the other! medicine as an effective analgesic
and antipyretic.
What is this Paracetamol?
Paracetamol is also used for the relief
Paracetamol or acetaminophen of pains associated with many parts of
chemically named N-acetyl-p- the body. It has analgesic properties
aminophenol, is a widely used over- comparable to those of aspirin,
the-counter analgesic (pain reliever) Available without a prescription; it has
and antipyretic (fever reducer). in recent years increasingly become a
common household drug.
Paracetamol is classified as a mild
analgesic. It is commonly used for Prior to the usage of Paracetamol as
the relief of headaches and other antipyretic drugs; Asprin was used to
minor aches and pains and is a major bring the fever down. Aspirin causes
ingredient in numerous cold and gastric irritation and it is a blood
flu remedies. In combination with thinner and thus cannot be used in
opioid analgesics, paracetamol can patients where coagulation ( clotting
also be used in the management of blood) is a concern, whereas the
of more severe pain such as post- Paracetamol does not cause gastric
surgical pain and providing palliative irritation. However, Paracetamol does
care in advanced cancer patients.. not help reduce inflammation like the
While generally safe for use at Aspirin . Paracetamol is usually taken
recommended doses (1,000 mg per by mouth in tablet or capsule form. It
single dose and up to 4,000 mg per is also available as liquids for children.
day for adults), acute overdoses of
Safe recommended doses :
paracetamol can cause potentially
fatal kidney, brain and liver damage 1,000 mg per single dose and up
and, in rare individuals, a normal to 4,000 mg per day for adults.
dose can do the same. Paracetamol usually comes in a 500mg
Medical uses tablet or capsule. It is also available
Paracetamol is approved for reducing in slow release (SR) 665mg tablets.
fever in people of all ages.The Liquid paracetamol is available for
World Health Organization (WHO) children. The dosage depends on the
recommends that paracetamol only child’s age.
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The usual dose is 15mg per kg of pain or fever. It is preferable to ask
body weight. Liquid paracetamol your doctor or pharmacist if you are
comes in different strengths so it is
uncertain about how often to take
very important you check the strength
to ensure that the dose above what is your medicine.
required is not administered. Paracetamol can be taken safely
The dose may need to be reduced during pregnancy or when
if you have liver problems. breastfeeding.
FREQUENCY OF DOSE: Although paracetamol is
Paracetamol can be taken when administered to bring down
needed, that is when you feel the fever in a patient, it is advisable
pain or have fever, or it may be taken to consult your doctor if the fever
regularly to manage persistent pain
persists beyond 3 days and do
or fever. It is usually taken every 4 to
8 hours depending on the potency further investigations to rule out
of the drug and the intensity of any serious infection.

FEW DRUG CLASSIFICATIONS

• NSAID – Non steroidal anti inflammatory drug
• Therapeutic Action Classification
Analgestic - Relieves pain
Antipyretic - Brings down fever
• Schedule H -These are drugs which cannot be purchased over
the counter without the prescription of a qualified doctor.
The manufacture and sale of all drugs are covered under the
Drugs and Cosmetics Act and Rules
• Schedule G – These are drugs to be used only under medical
supervision
• OTC – Over the counter drugs. These can be procured
without a medical prescription.
Paracetamol Is Classified As Aniline Anaglesic As It Is Derived
From Coal Tar And It Is An Analgesic.

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 CONSUMER’S DIGEST OF CAI JANUARY 2013

Habitual use of paracetamol leads to decrease in threshold for pain in a person.

This means that the endurance level for pain reduces in that person.

BEWARE!!! DO NOT HASTEN YOUR LIVER DAMAGE!!!!!!

Consuming more than 4 standard drinks at a time is likely to leave one with a
hangover headache!! The most common thing to do is to pop a paracatamol tablet
to get relief!!
This is very dangerous!! The liver damaging effect of alcohol is enhanced by taking
the paracetamol tablet. Alcoholics or patients with liver damage should be careful
about using Paracetamol.

COMPARATIVE TESTING Department of Consumer Affairs,

Government of India. This is the
Comparative Testing is a formal second year and Concert will be
process by which different brands of testing 7 products and 3 services one
a product category are tested for : of which is Paracetamol.
• Conformance to minimum
standards laid down by Bureau
BRANDS CHOSEN FOR TESTING
of Indian Standards Paracetamol Tablets:
• Test how different brands exceed 1. Paracetamol Tablets 500 mg (Jan
these standards or fall short Aushadhi) made by IDPL (TN)
• An empirical analysis of what you Ltd, Chennai
get for your money 2. Paracetamol Tablets 500 mg
(Tamil Nadu Government
• Assess the inflated claims supplies) made by Endoven
of manufacturers to see if Pharmaceuticals Pvt. Ltd,
consumers get what they pay for Hyderabad
• Relative performance of various 3. P-500
brands 4. Pacimal
• The test results are published 5. Pyrigesic
helping the consumer to make 6. Calpal
an informed choice.
7. Crocin Advance
CONCERT has undertaken this
8. Paracip
project of Comparative Testing for
Southern Region under a grant from 9. Metacin

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10. Acticin Drugs and Cosmetic Rules 1945
11. Fepanil (manner of labelling) mandates the
following minimum information to be
12. Dolo 650
put on the label of all OTC medicines:
13. Pararite - 500
a. Generic and Trade name
14. Paracetamol Tablets IP (500 mg)
made by Locost, Baroda b. Net contents and content of
active ingredient
Paracetamol – Paediatric Dosage: c. Date of manufacture
1. Calpal 250 mg Oral Suspension
d. Date of expiry
2. Crocin Oral Suspension e. Name and address of
3. Fepanil 250 Oral Suspension manufacturer including
4. Lotemp Oral Suspension manufacture and the license
5. Dolopar 250 Oral Suspension number
6. Paracip 250 Oral suspension f. Batch number, manufacture and
expiry date
7. P - 250 Oral Suspension
g. Maximum retail price
PARAMETERS TESTED were as per the h. Warning legend
standards prescribed in the INDIAN i. Directions for use/Dosage
PHARMACOPEIA j. Net quantity
k. Storage condition
1a) Labelling
1b) Warning Legend
Mandatory labelling Requirements of Paracetamol should carry the warning
OTC Drugs in India – Overdose causes Liver Damage

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 CONSUMER’S DIGEST OF CAI JANUARY 2013

2. QUALITY 10 tablets weighs 10gms then each

tablet should weigh 1gm if there is
(i) Identification Test is carried out
uniformity of weight.
to ascertain the identification of the
active ingredient. This is a preliminary This test ascertains that all the tablets
test done to ascertain the presence of weigh 1gm each and the individual
the active ingredient and to ensure tablets are not packed in varying
that a low cost isomer (same chemical weights.
composition but different molecular
To ascertain this, 20 tablets are
structure) which is ineffective, is not
weighed on an electronic scale and
added.
the average weight is determined
(ii) Aminaphenol Test is done to and the % deviation is recorded.
ensure the purity of the active
ingredient and it is an indication of 3. POTENCY AND EFFICACY
the absence of impurity. It also helps (i) Dissolution Test is carried out to
determine the impurity profile if determine the compliance with the
persent. dissolution requirements. It is an
(iii) Relative substance Test is done indication for efficacy and potency of
to identify and quantify the active the drug. If the drug is not dissolved,
ingredient. This is done using TLC it will not be absorbed and hence will
or Thin layer Chromatography and not have the desired effect.
comparing the result of the sample (ii) Assay is an assurance that the
with the standard. formulation contains the quantity of
(iv) Uniformity of contents (weight) active ingredient as claimed on the
indicates that the formulation label. It is an indication of the efficacy/
manufactured is uniform in terms of potency of the drug and helps in
its content of active ingredient in all therapeutic monitoring. The assay
the packs. For instance if a strip of range is as indicated below.

Tablets Suspensions
< 95% – Fail -0 <90% – Fail – 0
95% – minimum – 2 90% – 95% – 2
> 95% – <100% – 3 95% – <100% – 3
100% to 105% – 4 100% – 110% – 4

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Assay reading is a clear indication of quality and efficacy
As per Indian Pharmacopeia (IP) presence of 95% of the active ingredient is
sufficient to meet the statutory requirement. Thus the drug which has a lower
assay reading has compromised on the quantity of the active ingredient used
thus bringing down the efficacy; more the active ingredient more effective is
the drug.
A drug with an assay reading of 95% will contain 95% of the active ingredient
and a drug with 110% assay reading contains 110% of active ingredient. 10%
excess of the active ingredient is used in the manufacturing.
The Assay results for the various brands are tabulated below
TABLETS – Range 95 - 105%
BRAND NAME ASSAY %
Jan Aushadhi supply (IDIMOL)* 97.97
Tamilnadu Government
96.89
supply(Endoven)*
Calpol 98.70
Crocin Advance 98.37
Paracip 500* 99.64
Metacin 98.05
P -500 99.60
Pacimol 99.91
Acticin 97.00
Pyrigesic 99.54
Fepanil 99.36
Locost* 98.39
Dolo – 650 101.27
Pararite - 500* 101.11

*Generic- The branded drugs identified as generic by the pharmacists

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 CONSUMER’S DIGEST OF CAI JANUARY 2013

ASSAY RESULTS – SUSPENSION (Range 90 - 110%)

Brand Name  Paracip Dolopar P-250 Calpal Fepanil Lotemp Crocin
Assay (%) 93.7 100.45 101.25 103.48 99.5 99.67 101.83

Scoring and Rating for Paracetamol Tablets

Total score by
Efficacy/ different
Brand Name Labelling Quality
Potency
Weightage(%)
Jan Aushadhi
Good Good Fair 75.00
supply (IDIMOL)*

Tamilnadu
Government Fair Good Good 82.78
supply(Endoven)*
Calpol Good Good Good 85.00
Crocin Advance Fair Good Good 82.78
Paracip 500* Good Good Good 85.00
Metacin Good Good Good 85.00
P -500 Good Good Good 85.00
Pacimol Good Good Good 85.00
Acticin Good Good Good 85.00
Pyrigesic Good Good Good 85.00
Fepanil Good Good Good 85.00
Locost* Good Good Good 85.00
Dolo – 650 Good Good V.Good 90.00
Pararite - 500* Good Good V.Good 90.00

*Generic - The branded drugs identified as generic by the pharmacists

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SUSPENSION

Total score
Price
Brand Efficacy / by different
Labelling Quality (MRP in
Name Potency weightage
Rs) 60ml
(%)
Paracip Good Good Fair 70 35
Fepanil Good Good Good 80 35.00
Lotemp Good Good Good 80 50.80
Dolopar Good Good V. Good 90 34
P - 250 Good Good V. Good 90 35.10
Calpal Good Good V.Good 90 35.75
Crocin Good Good V.Good 90 33.73

SCORING METHODOLOGY
TEST RESULT SCORING
QUALITY
Identification Fail/ Pass 0/2
4 Aminophenol test Fail/ Pass 0/2
Relative substance Fail/ Pass 0/2
Uniformity of weight Fail/ Pass 0/2
EFFICACY/POTENCY
Dissolution( only for Tablets) Fail/ Pass 0/4
(Range 0 to 4)
Uniformity of weight Fail/ Pass 0/2
Assay* Fail/ Pass 0/4
(Range 0 to 4)
LABELING
Label as per act Fail/ Pass 0/2
Warning Legend Yes/No 2/0

*Assay range and scores are as indicated in the assay table for Tablets and
Suspensions
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 CONSUMER’S DIGEST OF CAI JANUARY 2013

Weightage: than the brand name The label

of Crocin Advance does not give
Labelling = 20%
the generic name prominently as
Quality = 30% mandated by the Act.
Efficacy and potency = 50% • pH for paracetamol suspension
while rating the drug. is a vital factor in Stability of
OBSERVATIONS AND the formulation and on its
RECOMMENDATIONS absorption. IP does not specify
this parameter. It is specified in
Paracetamol suspension is sold USP. We recommend considering
under the brand names inclusion of specification for pH
Crocin Suspension value in IP standards .

Lotemp • Jan Aushadhi supplies IDIMOL

brand made by IDPL, Tamil Nadu.
Fepanil 250 This has passed the Dissolution
Calpol 250 Test only in S2 stage; this
indicates that the formulation
P - 250 needs improvement.
Indicate different pharmacopeial • Paracip brand of suspension
name like acetaminophen oral made by HSN International,
suspension as in USP ( United States Hardwar, and marketed by CIPLA,
pharmacopoeia) , Paracetaml oral Mumbai tested 93.7% assay
Suspension BP as in BP (British content; this is closer to lower
pharmacopoeia). limit of 90% specified in IP for
• As per the Drug and Cosmetic suspensions.
Act, the generic name given As mentioned earlier Assay is an
in IP Standard is Paracetamol assurance that the formulation
suspension. The IP licensing contains the quantity of active
authority can insist that the ingredient as claimed on the label.
Generic name should be same as
the Pharmacopeia name given in Paracetamol is a simple and
the IP Standards. stable formulation and the Indian
Pharmacopoeia allows up to a
• Crocin Advance minimum of 95% assay content.
As per Rule 97 of the Drugs and Manufacturers use this range (95% –
Cosmetics Act, the generic name 100%) in the specifications and make
should be indicated in a more these products just to satisfy the
conspicuous manner on the label lower limit thus qualifying for many
11
Government tenders. The Assay range should be increased to 100 - 105% to
ensure the quantity of the active ingredient is not compromised.

The table below indicates the price per tablet which starts from 0.24 paisa and
goes up to a maximum of Rs 2/- per tablet which is almost 8 to 9 times the price of
the lowest brand listed.

Price per Tablet

BRAND NAME Price (Per Tablet) in Rs

Jan Aushadhi supply (IDIMOL)* 0.24
Locost* 0.44
Pararite - 500* 1.05
Paracip 500* 1.10
Metacin 1.12
P -500 1.20
Calpol 1.21
Pacimol 1.21
Acticin 1.25
Fepanil 1.29
Pyrigesic 1.30
Dolo – 650 1.93
Crocin Advance 2.00

Why does the price of the tablets vary so much?

What are generic and branded drugs? When a pharmaceutical company

discovers a new drug to treat or
Is there a difference in quality
between the generic and branded prevent a condition or disease, they
drugs? put it through a series of clinical trials
in order to gain approval for marketing
What is patenting of drugs? Why is it from the Medicines and Healthcare
done? products Regulatory Agency. If the
The answers to these questions helps clinical trial results show that the
a consumer to make a right choice as new drug is safe and effective for the
follows: treatment of a particular condition,
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 CONSUMER’S DIGEST OF CAI JANUARY 2013

the regulatory authorities approve the wondering if it is truly generic! Since

drug and give a licence. The company as per the definition a generic drug
then has exclusive rights to market should be sold by the chemical name,
the medicine for the licensed uses for i.e as Paracetamol.
a certain period of time, usually about
Such drugs are called “Branded Generic
10 to 12 years. This is known as a
drugs.” This is an oxymoron (figure of
patent, and allows the drug company
speech which combines contradictory
to recover the costs of research and
terms), but this is the way the Indian
development of the new medicine,
Pharmacists identify the generic
before other drug companies are
paracetemol
allowed to produce it as well.
The generic drugs without any brand
Once a patent expires, other drug
names are packed in thousands and
companies then have the right to
not individually. These are meant for
manufacture and market the generic
hospitals and dispensaries. In our
drug. However, they must market
country the common man has access
it under a different brand name, or
only to branded Generic drugs.
under its generic name. Then the cost
of the drug will be reduced due to BRAND NAME OR TRADE NAME
open competition and the company
It is the trade name the manufacturer
which originally patented the drug
gives to the medicine. It is chosen by
has recovered all the expenses
the manufacturer usually on the basis
incurred in developing the drug.
that it can be easily pronounced,
In India however there were no recognised, or remembered. For
patent laws till 2005 which meant example, paracetamol is a generic
that anyone could replicate any drug name.
in India without legal ramifications.
Calpol, Crocin, Dolo, etc. are the
This led to the trend of branded
brand names or the trade names of
generic drugs.
the paracetamol given by different
Generic name: a generic name that is manufacturers
the active ingredient of the medicine;
When a doctor is writing a
drugs which have the same chemical
prescription, or a consumer is buying
composition as branded drugs are
an over-the-counter medicine, they
sold under their chemical name.
have a choice between a branded
In India, if you go to the pharmacy medicine and the generic version of
seeking a generic paracetamol, the that medicine. Generic medicines are
pharmacist will hand you a strip of sometimes cheaper than brand-name
paracip or pararite. This will leave you medicines, but the active ingredient

13
 If the doctor has prescribed a
medicine by its brand name, the
pharmacist will dispense that
brand. However, if a medicine
has been prescribed by its generic
name, then the pharmacist can
dispense whatever version of the
medicine they have available,
because each version will have
the same therapeutic effect,
regardless of whether one
manufacturer makes the tablets
(the ingredient that produces the a different shape or colour.
therapeutic effect of the medicine) is
the same in both. Generic prescribing helps in lowering
the medicine cost. Sometimes we will
Medicines also contain inactive seek a particular medicine, because
ingredients, which are used to we find that size and shape of tablet
formulate the active ingredient easier to swallow, or because it is
into a tablet, liquid, cream or a different colour from your other
other preparation. These inactive medicines and stops you getting
ingredients are called excipients, confused between them, that your
and different manufacturers do not pharmacist should normally be happy
always use the same ones when to always give you that version.
formulating their product. DOCTORS CANNOT ALWAYS PRESCRIBE
This is the reason why medicines GENERIC MEDICINES
containing the same active ingredient, There are a handful of medicines that a doctor
but made by different manufacturers, must prescribe by the brand name only.
may vary in appearance.
Because different brands of these medicines
The excipients used may create small may differ significantly in the way they are
differences between them, such as in absorbed. If a different brand than usual is
colour, or the amount of time it takes taken, the blood levels of the active ingredient
for a tablet to dissolve in the gut and could stray outside the required therapeutic
be absorbed into the bloodstream, range. If the amount in the blood becomes
but these differences are rarely too low, the effect of the medicine may be
significant, which is why generic and lost; if the amount in the blood becomes too
branded medicines are (with a few high, there may an increased chance of side
exceptions) interchangeable. effects.

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 CONSUMER’S DIGEST OF CAI JANUARY 2013

E.g: Our test results show that many generic

(brands) are as good as the branded
Modified-release theophylline for
ones
asthma, e.g Nuelin SA, Slo-phyllin,
Uniphyllin continus • Mindset of a person is that
costlier the medicine more
Modified-release aminophylline effective it will be! Since the
for asthma, e.g Norphyllin SR, generic drugs are cheap, people
Phyllocontin continus who can afford branded drugs
MORE ABOUT GENERIC DRUGS don’t buy them believing them
to be of inferior.
• Generic drugs are sold • An opinion lingers that the
everywhere including your local private doctors would never
chemist. To buy them one simply hand out generic drugs because
has to ask for the generic version there are no kickbacks or
of a branded drug though there incentives involved from pharma
may not be be a generic form companies.
for all medicines.
• There’s a need to strengthen the
• Government had set up a Jan Aushadhi scheme and break
scheme called Jan Aushadhi down the doctor-big pharma
whose purpose was to set up nexus.
generic drugstores around the
READING THE LABEL AND USING THE
country.
MEDICINE AS PER THE DIRECTION IS
• Doctors and chemists have the VERY ESSENTIAL FOR THE MEDICINE
impression that the generic TO BE EFFECTIVE.
medicines are less effective.
In fact some doctors avoid Sometimes, special directions for use
prescribing generic drugs as are displayed on the label.
far as possible and even go to METHOD OF ADMINISTRATION
the extent of handing out free
samples of branded drugs to Some drugs produce the required
patients who cannot afford therapeutic action only when they are
branded medicines. administered through the particular
route. For example, insulin, the anti-
• Doctors also aren’t aware about diabetic drug, should be administered
their availability due to lack of subcutaneously, (by injection) as
advertising and marketing. it is degraded by the enzymes in

15
the gastro-intestinal tract if it is recommended on the label (example
administered through the oral route. “Keep in a cool, dry place”) to
maintain drug stability — i.e, to
• i.v/i.m: only for injections.
prevent contamination and as far
• Oral: for the drugs which can be as possible deterioration. It may be
administered through mouth. necessary to control elements such
as temperature, moisture and light. If
• Sublingual: for drugs which
not stored properly, the medicine may
should be placed under tongue.
expire well before the expiry date.
• For external use only : For drugs
• Cold — 2-8°C
meant for external use (should
not be taken internally) for • Cool — 8-25°C
example, creams, gels, etc. • Room temperature —
Temperature prevailing in a
• For nasal use only : for drugs for
working area
inhalation through the nose.
• Warm — 30 - 40°C
Special instructions • Excessive heat — above 40°C
Shake well before use - For • Ointments should be kept
suspensions like antacids (Gelucil). below 30°C. Do not freeze.
Suspensions have a tendency to settle Protection from freezing
at the bottom of the container. So,
if it is not mixed properly, the body It is indicated where there is a risk
will not be getting proper amount of of breaking the container or where
active ingredients for the therapeutic freezing leads to loss of strength or
action. potency.
Not to be refrigerated
Keep out of reach of children
For example, soft gelatin capsules
Sugar-coated and beautifully coloured should not be refrigerated.
tablets/capsules are available - for
example iron tablets. Children may Protection from light
mistake them for candy, so they must Store in a dark cupboard or use a
be stored out of reach of children. (If light-resistant container.
they are ingested in large numbers, it
may lead to drug toxicity.) Physician’s sample — not to be sold

Storage conditions The label of sample drugs should

display this. Sample drugs are not
Storage conditions should be meant for sale.
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 CONSUMER’S DIGEST OF CAI JANUARY 2013

Dosage as directed by the physician Try to develop a habit to observe the

label of each and every drug. This will
The dose of a drug or the time interval
help you in proper usage and storage of
between the doses is never increased
drugs. If in doubt , ask your pharmacist
or decreased unless directed by the
for help.
physician. In most situations, drugs
are administered in such a way as to Medicines are an integral part of life.
maintain a steady state of drug in the Awareness should be created in the
body. The extent to which patients public to observe the
follow the instructions of doctor
on medicine is called adherence or drug label for safe and effective use of
compliance. medicine. For that, it is important to
understand what is
It is often found that the patients do
not follow or fail the dosage schedule displayed in the label of a drug that
prescribed for them. Non-adherence has certain identifying information.
can worsen the quality of life.
Read label carefully for the following:
For example, missed doses of
Expiry date
medicines of heart problems may
lead to more complications. Dosage
In the case of antibiotic therapy, Warning
missed doses of medicines are
not only the problem of individual Method of administration
patients but are a global threat. Storage conditions
The drug becomes ineffective at
the moment and also ineffective Next time when you buy medicines
permanently due to the development please ask the pharmacist to give you
of new strains of bacteria which is the generic medicine, if available.
capable of being drug resistant. The
Remember the generic drugs we are
result is new powerful drugs have to
be developed and introduced to get a referring to are those brands identified
germ-killing effect. as generics by the pharmacist.

1. Mr. M. Bhaskaran, Former Drug Controller – CL

2. Mr. K. Bharathidasan, Manager, CS/Sales – Life Science Services,
R&D/QC, SGS India Ltd., Chennai – EAC member
3. Mr. N. Nagasundaram, Dy. GM(QA), Fourtts (India) Laboratories
Pvt. Ltd. – EAC member
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