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US FDA completes the inspection of FDC's Waluj and Baddi facilties

FDC-Logo.png

FDC LogoFDC or Fairdeal Corporation as it was called back in 1986 prior to its listing in 1996 is a fully integrated pharmaceutical company.

FDC manufactures and markets APIs and various types of finished formulations: tablets, capsules, granules, oral powders, oral liquids, external powders, creams, ophthalmics, and specialized infant foods.

Oral Rehydration Salts

The company has facilities at Roha, Waluj and Sinnar in Maharashtra, Verna in Goa and Baddi in Himachal Pradesh and markets more than 300 products in India and the most famous or known product would be Oral Rehydration Salts (Disclosure: Analyst or family do not hold this stock but are users of the company’s products).

While this company is not in the same basket as Dr. Reddy, Lupin, Sun or other Pharmacos either in terms of market capitalization or even market share, the company was way back in 2006 rated as the “BEST UNDER A BILLION COMPANIES” by Forbes (more here). This is still a small company with a little over 1,000 crore in market capitalization with its stock has been trading at 180 levels since the start of this year.

FDC Forbes 2006

The company currently has a cumulative 34 DMFs or Drug Master File (DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF) and has generated revenue of Rs. 1,006 crore in FY16 and a Profit after tax of Rs. 156.62 crore in FY16 compared to Rs. 148.15 crore in FY15.

FDC vs IPM Value Growth

Well, the company today announced the completion of the US FDA inspection of its plants at Waluj and Baddi (click here for the announcement).

FDA Logo

The Waluj facility in Auragabad manufactures Ophthalmics, Oral liquids, Oral powders and External powders. This facility has approvals from the USFDA, UKMHRA, PICS and W.H.O. The products manufactured are exported to US, Europe, South America, Asia-Pacific and African countries.

The US Food and Drug Administration (US FDA) has carried out an audit yesterday (1-Jul-16) in relation to cGMP or Current Good Manufacturing Practices for product Dorzolamide Ophthalmic Solution (used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma). The inspection has resulted in 2 minor observations for which the company is planning to take appropriate steps (the observations have not been disclosed to the general public).

FDC Limited Share Price July 2016

The Baddi facility in Himachal Pradesh manufactures Cephalosporins and its combination products. This facility is approved by W.H.O. and currently caters to the needs of the Indian market.

The US Food and Drug Administration (US FDA) had carried out the audit of this facility back in February, 2016 in relation to cGMP or Current Good Manufacturing Practices and for the ANDA (Abbreviated New Drug Application) for the product Cefixime (Cefixime is a cephalosporin antibiotic. It works by killing sensitive bacteria). Unlike the Waluj facility, the US FDA provided an Establishment Inspection Report (EIR) with “No observations”.

Source: Company Presentation (here)

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Disclaimer

Nothing in this newsletter is financial advice and should not be construed as such. Please do not take trading decisions based solely on the matter above; if you do, it is entirely at your own risk without any liability to Capital Mind. This is educational or informational matter only, and is provided as an opinion. 

Disclosure: The authors at Capital Mind have positions in the market and some of them may support or contradict the material given above, or may involve a direction derived from independent analysis.

  • Puru Ji says:

    What is your general view on FDC price? Is negative priced in already in the stock? After a consolidation from last few months it has already broken the resisitance on upside. Is it worth to be in your watchlist?