Concord Biotech Ltd - Stock Valuation and Financial Performance

Concord Biotech was originally incorporated as ‘Servomed Pharmaceuticals Private Limited’ (Servomed) at Ahmedabad, Gujarat as a private limited company under the Companies Act, 1956, pursuant to a certificate of incorporation dated November 23, 1984, issued by the Registrar of Companies, Gujarat, at Ahmedabad (RoC). Servomed was authorized to carry out business of manufacturing, producing, refining, importing, exporting, dealing, distributing, wholesaling, retailing etc. of drugs, medicines, cosmetics, baby food, pharmaceuticals, antibiotics and similar or allied products. At the time of its incorporation, Servomed had three directors, namely, Surendra Shah, Madhukant Shah and Indravadan Shah. An application dated June 24, 1985 was filed for undertaking the change in the name of the company to ‘Concord Pharmaceuticals Private Limited’ as the name ‘Concord’ was capable of being easily pronounced and popularized in the pharmaceuticals industry, pursuant to which a revised certificate of incorporation dated September 24, 1985 was issued by the RoC. Subsequently, with effect from December 26, 1986, Concord Pharmaceuticals Private Limited deemed to have become a public company pursuant to Section 43A of Companies Act, 1956. Thereafter, the name of the company was changed to ‘Concord Biotech Limited’ as the new management of the company decided to use the available plant and machinery for biotechnology products, and a fresh certificate of incorporation dated February 16, 2001 was issued by the RoC. Subsequently, the company became a public company from a deemed public company and a fresh certificate of incorporation dated November 7, 2001 was issued by the RoC.

It is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology in terms of market share, based on volume in 2022 (Source: F&S Report), supplying to many countries including regulated markets, such as the United States, Europe and Japan and India. It commanded a market share of over 20% by volume in 2022 across identified fermentation-based API products, including mupirocin, sirolimus, tacrolimus, mycophenolate sodium and cyclosporine. In 2016, it launched its formulation business in India as well as emerging markets, including Nepal, Mexico, Indonesia, Thailand, Ecuador, Kenya, Singapore and Paraguay, and have further expanded to the United States. 

It manufactures (i) bio-pharmaceutical APIs through fermentation and semi-synthetic processes, across the therapeutic areas of immunosuppressants, oncology and anti-infectives; and (ii) formulations, which are used in the therapeutic areas of immunosuppressants, nephrology drugs and anti-infective drugs for critical care. APIs are active pharmaceutical ingredients which have effects such as preventing or curing diseases. Formulations refer to drug products that are used by patients, such as tablets, capsulesor injections. Immunosuppressants are drugs that are typically used by patients undergoing organ transplants, as these drugs suppress the immunity of the patient such that the body accepts the transplanted organ.

Business area of the company 

The company is an India-based biopharma company and one of the leading global developers and manufacturers of select fermentation-based APIs across Immunosuppressants and oncology.

Products of the company 

Immunosuppressant

• Tacrolimus
• Mycophenolate mofetil
• Mycophenolate sodium
• Cyclosporine
• Sirolimus
• Pimecrolimus

Anti-bacterials 

• Mupirocin 
• Mupirocin calcium
• Vancomycin hydrochloride
• Teicoplanin

Anti-fungals 

• Anidulafungin 
• Micafungin sodium 
• Caspofungi

Oncology drugs

• Temsirolimus 
• Everolimus
• Romidepsin
• Mitomycin
• Dactinomycin
• Midostaurin

History and milestone

• 1984: Incorporation of Servomed Pharmaceuticals Private Limited.
• 1985: Change in the name to ‘Concord Pharmaceuticals Private Limited’.
• 1986: Conversion to a deemed public company pursuant to Section 43A of Companies Act, 1956.
• 2000: Acquisition of the company by Mr Sudhir Vaid, one of its Promoters.
• 2001: Renaming of the company to ‘Concord Biotech Limited’.
• 2002: Expansion of production capacity of enzymes.
• 2003: Certification of its facility at Dholka for commissioning and commencement of production of various enzymesby technical consultants. 
• 2004: Investment by Rakesh Jhunjhunwala and Rekha Jhunjhunwalain the company. 2005: First USFDA inspection and classification of its API facility as acceptable.
• 2008: Second USFDA inspection and classification of its API facility as acceptable.
• 2010: Received drug master file registration certificate for tacrolimus hydrate from Pharmaceuticals and Medical Devices Agency, Japan.
• 2011: First EU GMP inspection of its manufacturing facility by Government of Upper Bavaria-Central Medicines Control Bavaria (GMP/GCP). 
• 2011: Initiated CRAMs services in areas of new chemical entity (NCE) or Generic APIs.
• 2012: Received original drug substance registration certificate for mycophenolate mofetil from Pharmaceuticals and Medical Devices Agency, Japan.
• 2013: Third USFDA inspection and classification of its API facility as acceptable.
• 2014: Received certificate of drug substance registry for Ciclosporin JP from Pharmaceuticals and Medical Devices Agency, Japan.
• 2015: Fourth USFDA inspection of its Dholka facility and conclusion of inspection as ‘closed’. 
• 2015: Second EU GMP inspection of its manufacturing facility. 
• 2015: Received accreditation certificate of foreign drug manufacturing for non-sterile drugs from Minister of Health, Labour and Welfare of Japan. 
• 2016: Established a facility at Valthera, Gujarat.
• 2016: Recognition of its in-house R&D facility located at Valthera by Ministry of Science and Technology, Government of India.
• 2016: Investment from Helix Investment Holdings Pte. Limited.
• 2017: First USFDA inspection at its Valthera facility and receipt of establishment inspection report.
• 2018: Fifth USFDA inspection and received ‘no action indicated’ classification for its facility located at Dholka.
• 2018: Grant of GMP certification from Food and Drugs Control Administration for Valthera and Dholka units Second USFDA inspection at its facility located in Valthera facility and receipt of establishment inspection report. 
• 2018: Established Joint Venture in Japan pursuant to growing business opportunities in Japan.
• 2019: Received two ANDA approvals. 
• 2019: Expansion of the company’s business in critical care segment in India. 
• 2019: Commencement of marketing of Mycophenolate Mofetil Capsules USP 250 mg.
• 2020: Board of the company permitted the layout plan for the proposed injectable manufacturing unit at Valthera facility. 
• 2020: Received two ANDA approvals.
• 2020: First shipment of Mycophenolate Sodium Tablets, in US market.
• 2021: Commenced operations at second API facility at Limbasi. 
• 2021: Third EU GMP inspection of its manufacturing facility located in Dholka.
• 2023: Completion of the USFDA inspection at its Limbasi facility.