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:
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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 South America, Africa, Middle East, Cih, South East Asia."
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