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Mohammad Shahbaz Alam

Kazakhstan is the world's largest landlocked country by land area and its territory of
2,724,900 square kilometres (1,052,100 sq mi) is larger than Western Europe. It has borders
with Russia, China, Kyrgyzstan, Uzbekistan, and Turkmenistan, and also adjoins a large part
of the Caspian Sea. The capital is Astana, where it was moved from Almaty in 1997. Islam is
the religion of about 70% of the population, with Christianity practiced by 26%;
0.1% Buddhists, 0.2% others (mostly Jews),Kazakhstan allows freedom of religion.
On 16 December 1991, Kazakhstan became the last Soviet republic to declare independence.
Its communist-era leader, Nursultan Nazarbayev, became the country's first President, a
position he has retained for more than two decades. Kazakhstan has stable relationships with
all of its neighbors. Kazakhstan is also a member of the United Nations, Organization for
Security and Cooperation in Europe, Euro-Atlantic Partnership Council and the Organisation
of Islamic Cooperation (OIC).
Kazakhstan has the largest and strongest performing economy in Central Asia. Supported by
rising oil output and prices, Kazakhstans economy grew at an average of 8% per year over
the past decade. Major exports of Kazakhstan include petrol, natural gas, uranium, wheat,
textiles, and livestock. Kazakhstans fiscal situation is stable. As of 30 September 2012,
foreign investors had placed a total of $177.7 billion in Kazakhstan.
Kazakhstan is officially a bilingual country: Kazakh, a Turkic language spoken natively by
64.4% of the population, has the status of "state" language, whereas Russian, which is spoken
by most Kazakhstanis, is declared an "official" language, and is used routinely in business,
government, and inter-ethnic communication, although Kazakh is slowly replacing it.
English, as well as Turkish, have gained popularity among younger people since the collapse
of the Soviet Union. Education is universal and mandatory through to the secondary level and
the adult literacy rate is 99.5%.
The pharmaceutical industry in Kazakhstan satisfies merely 15% of domestic
consumption,and mainly low-profit, generic (i.e. non-patented) medicines are produced in the
country. According to IHS Global Insight, in 2011, the Republic of Kazakhstan imported
drugs valued at $142 billion (704 million euros) which constitutes 86% of domestic
Polpharma, an investor from Poland, became the majority shareholder in Shymkent JSC
Khimpharm - a plant, which supplies 55% of Kazakhstan's pharmaceutical products. The
second largest company in terms of production (7%) in Kazakhstan is the Nobel Almaty
Pharmaceutical Factory; its main investor has been the Turkish company Nobel Ilac since
2002. The third largest firm in terms of production (5%) is the company Abdi Ibrahim
Global Pharm LLP , whose production facilities are located in the Almaty Province.

Kazakhstan accepts CTD dossier for registration and registration fee is USD 1200.
Registration takes 6-9 months time depending upon quality of dossier and documentation.
Factory inspection is must to enter into Kazakhstan. Now Kazakhstan started demanding
PSUR and pharmacovigilance system of the company for the safety of patient. This is one of
the regulated countries and for entry into this country requires strong regulatory team. Feel
free to contact us for further queries directly to