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Argentina Pharma Market: Dr. Palak Gupta
Argentina Pharma Market: Dr. Palak Gupta
Status is reachable
Population: 4.4 Mn
Major Cities: Buenos Aires, Córdoba, Rosario, Mendoza, Tucumán, La Plata, Mar del Plata
Destination Sea Port or Airport: Bahía Blanca is the most important seaport city of Argentina,
located south of the Province of Buenos Aires and the second largest on the Atlantic Ocean. Its
seaport is one of the largest in the country, being the only one with a natural depth of more than
10m.
§ Argentina is the 3rd largest pharma market in Latin America behind Brazil & Mexico.
§ The OTC segment is another area that holds a lot of potential for growth in the Argentinean
pharma market. 25% by total sales and 10% by value. Rx market approx 90%.
Top Companies: Roemmers one of the top company, more than 9% of the market, followed by
Bayer, Gador, Elea, Bago, Montpellier.
Pharma Star, the biggest distributor in Argentina command 65% of the total distribution of drugs.
Bago is the only Argentinean Phama Company with a potential to develop a blockbuster drug
that could catapult them into the global to 50.
Inspection of all Indian drugs and medicines had to be undertaken by the regulatory body,
ANMAT
Generally, it takes more than 90 days and could extend to up to more than one year depending on
the complexity of the product's technical aspects.
Products into three categories based on the countries in which they are manufactured:
> Drug products manufactured in Argentina or in an Annex II country, when there is a similar
drug product already registered in Argentina.
> Drug products manufactured in Argentina, with marketing authorization in any Annex I
country, even if there are no similar products registered in Argentina.
2. Article 4 Product
> Drug products with marketing authorization in at least one Annex I country.
> Drug products manufactured in Argentina, when there are no similar products already
registered in Argentina.
> Drug products manufactured in an Annex II country and not marketed in any Annex I country,
when there are no similar products already registered in Argentina.
> Drug products manufactured in a non-Annex I, non-Annex II country, and not marketed in any
Annex I country."
Argentina there are no generics and suggesting that the quality of the pharmaceutical products
classified as similar"
Plant inspection: No
For Annex II countries, manufacturing facilities are required to be inspected and approved by the
Argentinean Department of Health before export of these pharmaceutical products into
Argentina. Where such a site GMP inspection is required, this should be requested as early as
possible as, due to resource constraints, the site inspection may take up to two years to occur.
Approval time for Argentina was twice as fast as for Brazil, this is likely due to the fact that
Argentina uses a verification approval route whereas Brazil typically conducts a full dossier
review.
Brief:
Major Challenges: Control on imports & Exchange rates, squeezing margins, volatile inflation.
The market tightly controlled and dominated by the local distributors of multinationals from the
US, European Union and Switzerland
Argentine citizens today have access to specialty or high technology products due to a solid
reimbursement system.
Apart from LATAM, Argentine products reach almost every corner of the world like Southeast
Asia, Eastern Europe, parts of Africa, Lebanon, Pakistan and Kazakhstan as important markets
for the industry.
Domestically manufactured products are predominant 71% percent over imported products 29%.
The limited generic drugs exporters included Lupin, Ranbaxy and a few vaccine manufacturers.
In 2012-13, India sold $44.85 million worth of bulk drugs to Argentina
Indian companies with USFDA and EU certification can export freely to Argentina.
Argentina is in the process of submitting a list of 20 drugs for immediate import from India.
The prices of medicine in Latin American countries were three to twenty times the prices of
medicine in India.
Strides Arcolab Limited has a big market for its HIV drugs in Argentina. Catering to a niche
market or segment like AIDS will be fruitful for Indian companies.
There is a trend in decreasing of Pharmaceutical imports to the country and growing exports
from the country.
Argentina accepted Ayurvedic medicines. Companies such as Dabur and Himalayas have already
made entry.
Argentina and Brazil are looking for a manufacturing tie up with Indian companies for
intermediates and raw materials for pharmaceuticals that is essentially life saving
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