FDC Ltd

FDC Ltd

FDC Limited is a fully integrated research-oriented pharmaceutical company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). FDC's formulation department designs and develops products for various global markets and the highly regulated markets of US and Europe. The company has built a visible presence in the Regulated and Emerging markets. Promoted as a partnership firm in 1936 by the late Anand Chandravarkar to import pharmaceutical dosage forms specialised infant foods and surgical goods Fairdeal Corporation (P) Ltd as the company was known was converted into a private limited company in September 23rd 1940. It set up a formulation unit at Jogeshwari Bombay in 1949.FDC has 2 wholly owned subsidiaries namely FDC Inc. USA and FDC International Ltd UK and 1 Joint Venture business namely Fair Deal Corporation Pharmaceutical SA (Pty) Ltd. at South Africa as on 31 March 2019.FDC manufactures Electral oral rehydration salt (ORS) being a leader in this segment. FDC manufactures bulk drugs formulations and food products. The plant at Roha manufactures pharma dosage forms food products and bulk drugs for the anti-rheumatic anti-asthmatic opthalmic and ENT segments. The company part financed its technical upgradation/modernisation/backward integration/expansion plans from the proceeds of its initial public issue in Jan.'96. The company set up a modern manufacturing plant at Goa for manufacture of tablet dosage forms. The plant has commenced commercial production in Sep 2000. The plant is designed to meet UK/US standards on solid dosage form.In Feb. 2001 the company has signed a marketing tie-updeal with Aspen Pharmacare of South Africa. Through this alliance FDC will be initially marketing 10-12 ophthalmic products manufactured at its plants in India and approved by the UK Medicines Control Agency in South Africa.FDC will also enter into a licensing arrangement with Aspen Pharmacare for solid dosage forms and oral rehydration salts to be manufactured locally in South Africa at Aspen's facilities with knowhow from FDC. Aspen Pharmacare is the largest listed pharmaceutical company in South Africa and a dominant player in generic medicine. The total market for ophthalmic products in South Africa is estimated at Rs 78.70 cr and FDC hopes to achieve a 30% marketshare in five years.During 2000-01 the company's Roha plant manufacturing basic raw materials was inspected and approved by US FDA. The company is also setting up a modern manufacturing plant at a separate site in Goa. The plant will be a world class facilities with quality systems of International GMP Standards and it will also enable the company to enter into US market. The trial runs and commerical production is expected to be commenced in March 2004. To tap the Sub Sahara African countries FDC is planning to set up a marketing joint venture in South Africa and Russia.FDC is setting up a manufacturing facility at Baddi Himachal Pradesh for the manufacturing of Cephalosporin drugs. This facility is expected to be operational in 2006. The company has received approvel from US FDA for its sterile manufacturing facility for ophthamlmic dosage forms at Waluj Aurangabad and an analytical research and devrelopment laboratory at Jogeshwari Mumbai. Also the company is setting up an additional facility at Waluj by adding one more Form-Fill-Seal (FFS) machine during the year 2004-05.During the year 2004-2005 FDC has received a certification for its plant at Waluj conforms to the Quality Management System Standards ISO 9001:2000 and ISO13485: 2003 respectively. This will enable the company to enhance its exports to European countries.In the year 2004-05 the company has issued bonus equity shares in the ratio of 1:1.In 2006 The company has expanded its installed capacity of Basic Drugs Capsules and Formulations (Cream Powder Ointments etc.) by 2350 kgs 2000000 nos and 1342200 kgs respectively during the year. With this expansion the total capacity of Basic Drugs Capsules and Formulations (Cream Powder Ointments etc) has been increased to 119050 kgs 19.20 nos in crores and 7777920 respectively.The company has set up a production facility at Baddi Himachalpradesh the production at this new site will commence from July 2006.FDC concluded buyback of its fully paid-up equity shares of Re.1 each on August 16 2013. During the buyback period the company bought back 5087343 equity shares of Re.1 each and the total outlay for the buyback was Rs. 4651.17 lacs. All the equity shares bought back in the buyback offer were extinguished as on August 31 2013.During the year ended 31 March 2014 FDC's newly introduced Calcium-Phosphorus Supplement Calyumm-P suspension was launched at Paediatricians with much aplomb. Calyumm-P with its unique name & yummy flavour was well accepted and appreciated and was able to garner a good prescriber base at Paediatricians in the very first year of its launch.During the year under review FDC got approval from European regulatory agencies for two generics products. A number of products were developed for registration in CIS African countries and ROW.With regard to the Nutraceuticals business FDC has successfully completed HACCP Recertification Audit and ISO22000: 2005 Surveillance audit for Roha plant.2014-15 was the year for FDC wherein the new divisional structure was put into effect. The new structure was created not only to give a focused approach to few of mega brands of the company but also to ensure that FDC's presence is felt across different therapy areas (build newer Therapy Areas (TA)) where it has a presence. By doing so FDC has also ensured that it is aligned to the right TA's from a long term perspective. FDC now operates through 7 marketing divisions including 2 new specialty divisions namely Dilse and Pixel. The Dilse Division is a canopied basket of Cardiovascular and Anti-diabetic products of FDC. The Pixel Division is launched with a view to reaching 12200 numbers of Top Ophthalmologists. Overall FDC product basket covers 14 therapeutic segments with a strong brand portfolio.FDC's balanced energy drink namely 'ENERZAL' became the drink provider for the Mumbai Marathon 2015.In Nutraceuticals business FDC launched 'Enerzal' in Jar (Orange and Lime Flavour) during the year ended 31 March 2015.With regard to the license technology agreement signed by FDC for of recombinant Granulocyte Colony Stimulating Factor project the company has successfully completed the Pre-clinical Trials and received permission from the Department of Biotechnology to approach Drug Controller General of India (DCGI) for approval to conduct appropriate phase of Human Clinical Trials.On the Formulations business front in addition to the European markets FDC has grown its business in Australia in the financial year 2014-2015.In Nutraceuticals business FDC launched 'Enerzal' in Pet Bottle (Orange and Apple Flavour) during March 2016. With regards to recombinant Granulocyte Colony Stimulating Factor project FDC has modified the existing manufacturing facility at Jogeshwari to suit the cGMP requirement to manufacture recombinant protein for clinical trial. Area qualification of this new R&D Biotechnology process area was completed successfully. With reference to FDC's project on the development of third generation thrombolyte the company has approached an external party for process development and validation of the said thrombolyte molecule at downstream level and its subsequent technology transfer to FDC. Trial batches have been initiated at FDC and the Cell harvest shall be handed over to external party for development and validation of the purification strategy.FDC purchased the immovable property which was occupied by the company as a lessee from the lessors i.e. Ghaswalas admeasuring 8664 square meters located at 142-48 Swami Vivekananda Road Jogeshwari (West) Mumbai for a total consideration of Rs. 261 crore during the financial year 2015-2016.The Scheme of Amalgamation of Anand Synthochem Limited (a wholly owned subsidiary) Soven Trading and Investment Company Private Limited Sudipta Trading and Investment Company Private Limited and Transgene Trading and Investment Company Private Limited (Transferor Companies) and FDC Limited (Transferee Company) and their respective shareholders (the Scheme) which was approved by the Board on September 6 2014 and the members at court convened meeting held on June 13 2015 and public shareholders through Postal Ballot and e-voting on June 15 2015 was sanctioned by the Bombay High Court on September 4 2015. The Scheme has become effective on September 4 2015 with appointed date being September 1 2014. Accordingly the Transferor Companies stand merged with the Transferee Company and the merger has been given effect to in the financial statements of FDC Limited for the year ended March 31 2016. Consequently 55385000 equity shares of face value Re. 1 each held by the Transferor Companies in the Transferee Company has been cancelled and the Transferee Company has allotted 55385000 equity shares of face value of Re.1 each credited as fully paid up to the shareholders of Transferor Companies in accordance with the fair share entitlement ratio specified in the Scheme.During the year ended 31 March 2017 FDC launched various products in the market such as Ten DC & Ten DCM Vitcofol Hb Zocon KZ Shampoo etc. The company has also aligned itself in terms of portfolios & priorities in order to maintain its finest performance. In Nutraceuticals business FDC launched the Enerzal 500 ml in pet bottle as well as 1 Litre in Tetrapak with Orange and Apple flavor during the year ended 31 March 2017.With regards to recombinant Granulocyte Colony Stimulating Factor project inspection was conducted by Central Drugs Standard Control Organisation (CDSCO) along with Local Food Drug and Authority (FDA) in consideration to FDC's application to grant No-objection Certificate for manufacturing the clinical grade material. With reference to FDC's project on the development of Third Generation Thrombolyte it has obtained the Test License from Local FDA.The Board of Directors of FDC Limited in their meeting held on February 7 2018 had given their approval for Buy Back of the company's fully paid-up equity shares of Re. 1 each from the Tender offer through Stock Exchange route of upto 3430000 fully paid up equity shares of face value of Re. 1 each of the company at a price of Rs. 350/- per Share payable in cash for an aggregate Buyback consideration not exceeding Rs. 120.05 crore excluding transaction cost viz. brokerage applicable taxes such as securities transaction tax service tax stamp duty etc. cost for the intermediaries appointed for the buyback and other incidental costs. The company completed the extinguishment of 3430000 Equity Shares comprising of (i) 3429951 Equity Shares in dematerialized form on March 28 2018 and (ii) 49 equity shares in physical form on March 29 2018 which were accepted pursuant to the aforesaid Buyback.During the year ended 31 March 2018 FDC has shifted to alternative formulae for brands falling under DCGI ban. Further the company has selectively launched the molecules viz. Itraconazole (Oral Antifungal) Brand Zitran Luliconazole (Topical Antifungal) Brand Zocon L Apremilast (Psoriatic arthritis) Brand Aprotyl Cranberry extract + D Mannose (UTI infections) - Brand AV UTI.With regard to G-CSF project the company has received the CDSCO Audit report on steps to be undertaken for grant of Non Objection certificate (NOC) to manufacture clinical grade material for human trials as required under Form 29. With reference to the company's project on the development of Third Generation Thrombolyte the company has obtained a refolding and purification strategy from the external party. With reference to the company's project on the New Chemical entity FDC has been successful in formulating the insoluble active molecule (TNF-04) for topical application and preliminary study is in progress for determining the efficacy of the molecule in animal model. On the Active Pharmaceutical Ingredients business front FDC has filed USDMF for Telmisartan and Cinnarizine and has received CEP Certifications for Dorzolamide Hydrochloride and Salbutamol Sulfate. The company was audited by EDQM and has received EU GMP Certification for the product Bromhexine Hydrochloride Active Pharmaceutical Ingredients.As on 31 March 2019 the Company has 2 (Two) wholly owned Subsidiaries namely FDC Inc. USAand FDC International Ltd UK and 1 (One) Joint Venture business namely Fair Deal Corporation Pharmaceutical SA(Pty) Ltd. at South Africa.The Board of Directors of the company in their meeting held on May 24 2019 had given their approval for Buy Back of the Company's fully paid-up equity shares of Re. 1/- each from the Tender offer through Stock Exchange route of upto 3430000 (Thirty Four Lakhs Thirty Thousand only) fully paid up equity shares of face value of Re. 1/- each of the Company at a price of Rs. 350/- (Rupees Three Hundred Fifty only) per Share payable in Cash for an aggregate Buyback consideration not exceeding Rs. 120.05 Crore.The buy-back of equity shares through the stock exchange commenced on June 07 2019 and was completed on July 23 2019 and the Company bought back and extinguished a total of 3430000 equity shares at a price of Rs. 350/- per equity share.The Company acted promptly to mitigate the impact of COVID-19 pandemic and the ensuing nationwide lockdown.The Board of directors at its meeting held on August 07 2020 have approved a proposal of the Company to buy-back its 2163000 fully paid-up equity shares at a price of Rs.450 per equity shares from all the eligible equity shareholders of the Company on proportionate basis through the Tender offer route in accordance with SEBI(Buy-Back of securities) Regulation 2018. The Buyback of equity shares through the stock exchange commenced on September 16 2020 and was completed on September 29 2020 and the Company bought back and extinguished a total of 2163000 equity shares at a price of Rs. 450 per equity share on October 15 2020.The Company had entered into definitive agreements for the acquisition of additional stake in Fair Deal Corporation pharmaceutical SA (PTY) Ltd. South Africa (`FDC SA') through secondary acquisition of 143000 equity shares of FDC SA having Face value of RAND 1 each and representing 44% of the share capital of FDC SA from Pharma Q Holdings Pty Ltd one of the joint venture partner. The various closing conditions and applicable compliance had been duly completed and FDC SA has became subsidiary of the Company by holding 93% of equity share capital of FDC SA.During the year 2021 the Company focused on widening its presence to new areas and deepening presence in existing ones. In US market it continued with strategy of filing additional ANDAs to support the existing basket of ophthalmic products. It developed ANDA batches of Azelastine Oph 0.05% Solution and Pilocarpine Oph Solution 1% and filed Ofloxacin Otic Solution 0.3% ANDA. In UK market exhibit batches of Preservative-Free Chloramphenicol Solution 0.5% was developed. It entered several new markets across Asia Pacific CIS Africa Middle East and LATAM. Further it filed several new API registrations and accreditations and maintained the existing ones including 10 Certificate of Suitability (CEP) applications for new and updating of the existing ones; 17 new API Drug Master File (DMF) applications for Ophthalmic range in Asia South-East Asia CIS Europe Africa and Latin America markets; and 4 DMFs updated as a complete DMF in `Base Line' format submission with the USFDA. It took advance purchase orders from overseas customers for Azithromycin 250mg and 500mg tablets and other products where API availability was a challenge to maintain adequate stock.The Company launched selective molecules like Favipiravir Hand Sanitiser Ivermectin Dexamethasone and Paracetamol during the year 2021. In total the Company launched the 13 brands such as 99F ATA Favenza Piflu Ivsit Salmodil-DX Salmodil-LS Zifi-SB Trigaurd Sanitiser Unox Cefponz Dexis and Zivas ASP 99F ATA Favenza Piflu Ivsit Salmodil-DX Salmodil-LS Zifi-SB Trigaurd Sanitiser Unox Cefponz Dexis and Zivas ASP in FY 2020-21.During the year 2021 the Company acquired an additional stake of 44% in Fair Deal Corporation Pharmaceutical SA (Pty) Ltd. pursuant to which it became a Subsidiary Company.In October 2021 an Indian company launched a Clinical Data and Insights (CDI) division to further strengthen its global presence and manage data-related aspects of its clinical trials. Further it launched Enerzal Blitz. In 2022-23 FDC launched Enerzal Zero Powder; launched Zefrich RTD 10gm to the market; completed trials for the infant milk substitute formulations for MumMum 1 MumMum 2 Simyl MCT and Simyl LBW to meet the regulation of the FSSAI and shifted to commercial level production; launched the immunity-boosting drink R5; Fortified Enerzal Powder with Natural Vitamin C Ginseng & Zinc completing a trial for product stability; Froze AV-Uti formulation and scheduled upcoming trials; developing other products including Enerzal with juice concentrate in all RTD formats Simyl MCT Oil fortification MumMum 1 fortification and Humyl reformulation.