FDC Ltd.

FDC make modest beginning in 1936, with marketing of vitamins and a range of prescription formulations. FDC set up its first formulations manufacturing facility in 1949. Subsequently, in 1963, FDC pioneered the manufacture of specialized ophthalmic formulations in India. FDC was the first organization to introduce the BFS (Blow-Fill-Seal) technology for ophthalmic in South East Asia. In 1972, FDC initiated the concept of Oral Rehydration Salts (ORS). Today its pioneer brand ‘Electral’ stands apart with a special identity- an impressive achievement in a fiercely competitive market. FDC’s API plant at Roha (Maharashtra) was among the first few API facilities in India to get US-FDA approval in 1984. Since then, FDC has to its credit a number of new molecules, introduced for the first time in the nation.

Today, FDC carries forward the flaming spirit of its first dream, achieving accreditations from the US-FDA, UK-MHRA, MCC-RSA, and the UAE, to cite a few. FDC is a forerunner in manufacturing and marketing of Oral Rehydration Salts (ORS) and Ophthalmics. FDC has also set-up globally approved, multi-location manufacturing facilities for Active Pharmaceuticals Ingredients (APIs) as well as Finished Dosage Forms. These facilities are located at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh. FDC markets hundreds of products in India and exports many of these to various countries.

Business area of the company

FDC Limited is among India’s leading fully integrated pharmaceutical companies. The Company is a pioneer in the manufacture of specialised formulations, and among the world’s foremost manufacturers and marketers of Oral Rehydration Salts (ORS). Over its long history of 85 years, the Company has maintained a distinguished reputation for high-quality, affordable products and built a market-leading brand portfolio.

Products

Formulations

FDC is a pioneer in the manufacture of specialized formulations, and the world's leading manufacturer of ORS (Oral Rehydration Salts) since 1972. It is a fully-integrated Pharmaceutical Company, with US-FDA and UK-MHRA approved API and formulations manufacturing facilities. FDC was the first in South East Asia to offer ophthalmic formulations, using Blow-Fill-Seal (BFS) technology.

It has its presence in numerous therapeutic segments: anti-infectives, gastrointestinals, ophthalmologicals, vitamins/ minerals/ dietary supplements, cardiac, anti-diabetes, respiratory, gynaecology, dermatology, analgesics and others. FDC’s Zifi, Electral, Enerzal, Vitcofol, Pyrimon, Zocon, Zoxan, Zathrin, Zipod, Zefu, Cotaryl and Mycoderm are leading brands in their respective segments in India.

Functional Food

Products that deliver benefits consistently are the hallmark of FDC's Food Division. These products have quality certifications such as BIS (ISI mark) and HACCP. FDC has a wide range of functional foods and beverages.

Few well known brands and their use/categories are: Prosoyal for lactose intolerance; Humyl as an ideal protein supplement; Zefrich as a complete family nourisher; Enerzal, a Balanced Energy drink; and Simyl MCT, Simyl LBW and MumMum 1 and 2 as infant milk substitutes.

API

To develop cost-effective, environment-friendly, high-quality APIs meeting stringent ICH standards is the main focus of FDC’s API division. The company’s products and manufacturing facilities have been inspected and approved multiple times by major Regulatory bodies such as US-FDA and WHO-GMP. Till date the company has developed over twenty-three APIs of which fourteen have already been commercialized and exported across the world.

Milestones

• 1936: Mr. Anand Chandavarkar set-up Fairdeal Corporation (FDC) to import drugs, infant foods and surgical appliances for distribution in India
• 1940: The Fairdeal Corporation was incorporated as a Fairdeal Corporation (Private) Limited Company under Indian Companies Act, 1913
• 1949: Formulation plant established in Jogeshwari, Mumbai
• 1963: Introduced Vanmycetin Eye Drops - starting point for ophthalmic and ENT range
• 1972: Introduced Electral - a result of pioneering work in Oral Rehydration Therapy
• 1974: Fairdeal's R&D facilities obtain recognition from Government of India
• 1977: Active Pharmaceutical Ingredient (API) plant commissioned at Roha, Maharashtra
• 1984: Foods division set up for manufacture of specialized infant foods at Roha
• 1985: First US FDA approval of API plant at Roha
• 1986: Fairdeal Corporation (Pvt.) Ltd. was renamed FDC Private Limited
• 1987: Multi-purpose formulation plant commissioned at Waluj in Maharashtra
• 1989: Started commercial production of Flurbiprofen
• 1991: Biotechnology research centre set-up at Waluj
• 1991: Production of Timolol Maleate (API) started
• 1992: National Award from the Council of Scientific Research and Industry (CSRI) for Indigenous R&D of Flurbiprofen and Timolol Maleate
• 1994: First Indian company to introduce BFS (Blow-Fill-Seal) technology in Ophthalmics, which optimizes sterility and is highly user friendly
• 1996: Public issue of 26,28,200 equity shares of Rs. 10 each at a premium of Rs. 90 each
• 1996: FDC awarded 'Export House' status
• 1996: Specialized & dedicated field force established to promote ophthalmic specialties
• 1998: UK-MHRA approval for ophthalmic facility at Waluj
• 1999: FDC International set-up in the UK for distribution and marketing of Ophthalmic products
• 2002: First UK-MHRA approval for oral solids facility at Goa Plant - I
• 2004: FDC South Africa established
• 2005: First US-FDA approval for ophthalmic facility at Waluj
• 2005: 2 ANDAs filed for ophthalmic dosage forms in the U.S.
• 2006: Forbes rates FDC among the 'BEST UNDER A BILLION COMPANIES'
• 2006: US Patent awarded for UV-Lube, the first definitive therapy for dry-eye syndrome
• 2008: US-ANDA approval received for three ophthalmic formulations
• 2008: US-FDA approval received for Waluj
• 2008: MHRA approval received for Goa unit - I
• 2008: New oral Cephalosporins facility set-up at Baddi
• 2009: UK-MHRA approval received for Goa units - I, II & III
• 2011: Pharmexcil CERTIFICATE OF APPRECIATION PATENT AWARD 2010-2011, in recognition of commendable contribution in Bulk Drugs Category
• 2012: UK-MHRA renewal received for Goa Plants - I, II & III
• 2012: US-FDA renewal received for Waluj
• 2012: Pharmexcil CERTIFICATE OF APPRECIATION PATENT AWARD 2011-2012, in recognition of commendable contribution in Bulk Drugs Category
• 2013: UK-MHRA renewal received for Waluj
• 2013: US-FDA renewal received for Roha
• 2013: IDMA Margi Memorial Best Patent Award for “BEST NEW CHEMICAL ENTITY PATENT AWARD 2012-13”
• 2013: Pharmexcil Patent Award “NEW CHEMICAL ENTITIES (NCEs) – SILVER AWARD 2012-2013”
• 2014: US-FDA renewal received for Waluj
• 2014: PICS approval received for Waluj
• 2016: US-FDA approval received for Baddi
• 2016: Pharmexcil Patent Award “NEW CHEMICAL ENTITIES (NCEs) – SILVER AWARD 2015-2016”.
• 2017-18: The company has launched the Enerzal 500 ml in pet bottle as well as 1 Litre in Tetrapak with Orange and Apple flavor.
• 2018-19: The company received the Abbreviated New Drug Application (ANDA) Approval for Dorzolamide 2% Ophthalmic Solution 5 ml & 10 ml.
• 2019-20: FDC receives GMP certificate from UK MHRA for Goa unit.
• 2020: FDC has launched new strength variants of its Favipiravir brands - PiFLU and Favenza, used to treat mild to moderate cases of COVID-19 in India.
• 2020: FDC inks pact to acquire additional stake in FDC SA.