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Our Mission, Vision And Values

Mission: We strive to provide standard generic medicines in the market at cost competitive prices

Vision: To gain the leading position in Acute & Chronic specialty therapies in our country as well as overseas.

Values: Executing a business plan that is guided by our core values which are Quality, Trust and Innovation.

Quality Aspects

Internationally benchmark - Quality and Regulatory systems

Flagship Biotech International Pvt. Ltd. is an ISO 9001:2008 certified company that has an impressive track record for maintaining quality in the products and production process. This has practically made us one of India's best Quality Control and Analytical Research Laboratories.

Quality control

Our strength lies in the Quality Assurance and Quality Control procedures that we strictly adhere to. We also follow the cGMP norms as well to improve our Product, Processes and the Skills of every team member. To ensure pure, safe and effective products such as Bortezomib Injection, Carboplatin Injection, we have established an advanced Quality Control (QC) Laboratory that conducts stringent tests methods to make medicines according to international guidelines. This department is well equipped with instruments for Analysis of API, Finished Products and Packaging

International Certifications

Our company has received many International certificates for the quality manufacturing procedures and products we make. The standard bodies that have issued certificates to us are:

  • WHO- GMP
  • USFDA
  • HEALTH CANADA
  • PPB KENYA
  • TFDA
  • PICS
  • MCC
  • NAFDAC
  • ANVISA
  • FDB

In addition to these, the Quality Certifications we have received are:

  • ISO 9001 : 2008
  • JAS ANZ
  • IAF

Regulatory Affairs

We prepare Technical Dossiers and Drug Master Files (DMFs) for all of our products and maintain a proper documentation for every product we make. In order to remain in compliance with the European and US Regulatory inspections, we regularly update our production facility that makes us eligible to enter Regulated Markets and ROW Markets.

Manufacturing Facility

Our organization is backed by the state of the art infrastructure that are designed to meet the stringent quality standards of the global market. These advanced manufacturing facilities are located in Tarapur near Mumbai (Maharashtra, India) Navsari, Baddi (Himachal Pradesh, India), Naroda (Gujarat, India). These facilities have advanced manufacturing capabilities that helps us to formulate Generic medicines in perfect combinations. Various global regulatory authorities such as WHO GMP, US FDA, MCC, PICS HEALTH CANADA have proved our production process.

Global CMO

Our firm is focused at developing efficient drugs through Formulation Development, Analytical Method Development and Stability Studies. We are offering CMO for existing and new rising markets which acts as a major revenue source for the firm. We have forged strong alliance with high ranking multinational generic companies across the globe with whom we make long term term contracts for development and supply of products. Under our CMO wing, we provide huge quantity of products that meet industry standards at cost effective prices.

R & D

Our well developed Research and Development center is based in Mumbai. It us focused on the development of existing and improvement of new products. The unit is manned by a team of scientists who hold several accolades in the chemical field. The center oversees an activities such as Product Identification, Lab Scale Development and full scale Batch Manufacturing.

Global Presence

Flagship Biotech International Pvt. Ltd. has garnered a large clientele in numerous countries in the last 75 nations. Hence, we offer our broad product range to countries in different continents such as:

  • Asia - Middle East: Egypt, Jordan, Syria, Bhutan, Lebanon, Iraq, Libya, U.A.E.
    South East: Cambodia, Indonesia,
    Afghanistan, Laos, Mongolia, Hongkong, Nepal, Myanmar, Philippines, Vietnam, Malaysia, Srilanka
  • Africa - Benin, Burundi, Burkina Faso, Egypt, Liberia, Kenya, Mali, Morocco, Madagascar, Mozambique, Mauritius, Namibia, Malawi, Nigeria, Sierra Leone, R.D. Congo, Seychelles, South Africa, Senegal, Uganda, Zimbabwe, Zambia
  • Latin America - Bolivia, Brabados, Cuba, Chile, Costa Rica, Dominican Republic, EI Salvador, Ecudor, Guyana, Guatemala, Honduras, Haiti, Jamaica, Nicaragua, Mexico, Panama, Paraguay, Peru, Suriname, Uruguay, Trinidad & Tobago, Venezuela
  • CIS - Armenia, Georgia, Belarus, Kyrgyzstan, Kazakhstan, Moldova, Turkmenistan, Russia, Ukraine
  • Australia & Pacific Ocean - Australia, Papia New Fuiana, Fiji, Timor-Leste

Milestone

Year

Achievement

2008

Planning to start a Pharmaceutical Unit

2009



February- Formation Of Partnership Organization

March- 1st Product Submission In TRINIDAD

October- ISO 9001: 2008 Certified

2010


June - 1st Product Registration in JAMAICA

June- MOH supply to TNT

October- Start up of Domestic Operation

2011


February - MOH supply to JAMAICA

April- MOH supply to CUBA

May- MOH supply to EL SALVADOR

October- Subsidiary Office in US

August Formation Of Private Organization

2012




March - MOH supply to PANAMA

April -1st Product Registration in PANAMA

November- 1st Product Registration in TNT

Development of New Products such as

Hydralazine Hydrochloride Injection USP

Capecitabine Tablets USP

Bleomycin Injection USP

Doxorubicin Hydrochloride Injection USP

2013




Jan- 1st Product Registration in HONDURAS

July- MOH supply to JORDAN

September-1st Product Registration in DR

October- 1st Product Registration in EL SALVADOR

December- 1st Product Registration in CUBA

Development of New Products such as

Teicoplanin Injection

Tigecycline Injection

Premetrexed Injection

2014



Development of New Product such as

Alprostadil Injection USP

Labetalol Hydrochloride Injection USP

Milrinone Lactate Injection

Caffeine Citrate Injection


"We are inviting inquiries only from international markets."

Disclaimer: Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities.

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