International Formulations

Alkem Lab's international operations diverge to focus into two distinct business groups - Regulated Markets and Emerging Markets. Today, Alkem Lab's has its presence in the USA, Australia and across 40 other countries worldwide.

Alkem Lab's envisions to be a global leader through focus in key markets by setting up of sales and marketing infrastructure and forging strategic alliances.

Alkem Lab's world class manufacturing facilities are approved by eminent regulatory bodies including US - FDA, UK - MHRA, TGA - Australia and MCC - South Africa amongst several other approvals from emerging markets.

Our world-class, cGLP compliant R&D infrastructure engage in development of API processes and novel forms, generic formulations, first-to-file opportunities and novel drug delivery systems.

Alkem Lab's has a state-of-the-art BA/BE center audited by the US - FDA and MHRA - UK. Our BA/BE centre supports the formulation R&D for ANDA, eCTD and other regulatory filings.

Alkem Lab's has an in-house intellectual property management cell with a team of competent patent attorneys. This team is involved in safeguarding and securing patent rights for Alkem Lab's products through analysis, strategic planning and indentifying patent challenging opportunities.

Regulatory affairs is crucial to Alkem Lab's global ambitions and we have ensured that our international operations are supported by our proficient team of regulatory specialists.

USA
Alkem Lab's seeks to be a successful player in US market and has the necessary infrastructure to achieve this objective. Alkem Lab's has a dedicated ANDA program and has received approvals for some of its filings while others are pending FDA approval. Alkem Lab's has forged strategic alliance with a sales and marketing entity to establish itself in the USA. We seek collaborations and alliances in areas of novel technologies, therapeutic classes and products which will help to accelerate our growth in this region.

EUROPEAN UNION
Alkem Lab's has partnered with several companies in Europe for marketing its products. In key markets like France, Germany, and the UK, Alkem Lab's has achieved ‘First to Launch' status for some of its products. We have also filed regulatory applications and are on the anvil of launching several products as part of our expansion plans in the continent.

AUSTRALIA
Alkem Lab's has strategic partnership with a reputed generic company which will facilitate the launch of our generic portfolio in Australia. With several molecules expected to go off-patent in the near future, Australia promises to be a major growth opportunity for Alkem Lab's.

EMERGING MARKETS
Given the importance of emerging markets and the business potential it holds, Alkem Lab's is taking its portfolio in specific therapeutic areas viz. anti-infective, cardiovascular, diabetes, gynaecology and CNS to these territories. Alkem Lab's currently has its presence in markets across specific countries in South-East Asia, South America, Russia-CIS and Africa where our branded generics are marketed.

In some key markets we have our own network of subsidiaries and representative offices. A strong field force supported by country managers drive our business in these chosen markets.

SOUTH-EAST ASIA
SRI LANKA: Alkem Lab's is one amongst the leading pharmaceutical companies in Sri Lanka and has more than 25 brands registered in the country, including leading brands like Taxim-O, Zocef and Clavam. Alkem Lab's has a dedicated field force engaged in sales and marketing of our brands in Srilanka.

THE PHILIPPINES
Alkem Lab's has established its own subsidiary - Alkem Lab's Corporation having its office in Manila and has currently over 50 regulatory filings in various stages of the approval process. Alkem Lab's products are distributed through Zuellig and has a dedicated field force engaged in sales and marketing.

AFRICA
NIGERIA
Alkem Lab's Nigeria Limited is Alkem Lab's registered subsidiary with a representative office in Lagos which imports, distributes and markets about 20 Alkem Lab's products. With a dedicated field force, our brands are promoted to clinicians across all major towns in Nigeria.

KENYA
Alkem Lab's has more than 25 brands registered in Kenya and several are under registration. Some of our leading brands in Kenya are Trinerve and Clavam. Alkem Lab's has a dedicated field force engaged in sales and marketing of Alkem Lab's brands in Kenya.

UGANDA
Alkem Lab's has 10 brands registered in Uganda while several are under registration. Some of our leading brands in Uganda are Taxim-O and Clavam. Alkem Lab's has a dedicated field force engaged in sales and marketing of Alkem Lab's brands in Uganda.

TANZANIA
Alkem Lab's has 9 brands registered in Tanzania and several are under registration. Some of our leading brands in Tanzania are Clavam and Xone managed by a dedicated field force engaged in sales and marketing.

SOUTH AMERICA
CHILE, COLUMBIA, VENEZUELA
Alkem Lab's has strategically decided to focus on three key markets in this region viz. Chile, Columbia and Venezuela. Alkem Lab's operates in these markets through a network of distributors and sales and marketing partners. Alkem Lab's has more than 50 products registered and several under registration in these countries. Alkem Lab's manufacturing facilities have undergone audits by regulatory authorities like INVIMA - Columbia. Brazil, an important market in the region is also on Alkem Lab's radar for strategic alliances.

CIS REGION
RUSSIA, UKRAINE, KAZAKHSTAN
Alkem Lab's operates in Ukraine and Kazakhstan through a strong network of distributors and sales and marketing partners. We have more than 12 brands in categories such as anti-bacterials, painkillers, nutraceuticals registered in these markets. Alkem Lab's has its representative offices in Almaty and Kiev, which through a dedicated field force directs the sales and marketing of Alkem Lab's brands in this region. Russia is an important market for us and we have several products under registration. Alkem Lab's looks forward to collaborations and alliances in this region.