Parabolic Drugs Ltd., a leading research-led Indian pharmaceuticals company has been granted 'Certificate of Suitability' (COS) for its key molecule Cefixime in the European Union (EU).
The COS is recognized by various signatory states of the European Pharmacopoeia Convention, the European Union and few non-member countries. Cefixime is one of top selling products for the company and the COS would enable the company to expand its presence in regulated markets.
The company has a European GMP certified Cephalosporin manufacturing site at Derabassi, with an annual production capacity over 700 tonnes. Cefixime, an oral third generation Cephalosporin Antibiotic, has a world market size of USD 839 million (September 2010, IMS) growing at 20.9% annually. The molecule is growing across the world for its basic use in the treatment of gonorrhea, tonsilitis and pharyngitis. The European market contributes to over 18% in the total sales for this molecule.
The company earlier had three COS certificates for molecules - Flucloxacillin Sodium, Amoxicillin Trihydrate and Cefuroxime Axetil.
The company's direct exports account for 32% of the total revenues for 9MFY11, with exports to regulated markets comprising 32% of the total exports.
Parabolic Drugs Ltd., a leading research-led API and API intermediates company, has posted a 163.65% rise in net profit at Rs. 14.29 crore for the second-quarter ended September 30, 2010 (Q2FY11) compared to Rs. 5.42 crore in the corresponding quarter ended September 30, 2009 (Q2FY10). Net sales increased by 16.23% to Rs. 161.43 crore for Q2FY11 as compared to Rs. 138.88 crore in Q2FY10. The company’s EBIDTA increased by 17.81% to Rs. 29.70 crore and the EBITDA margin improved by 57 bps during Q2FY11. On an equity capital of Rs. 61.89 crore, the fully diluted Earnings per Share (EPS) stood at Rs. 2.31.
The Company filed three Drug Master Files (DMFs) during Q2FY11, taking the total number of filings to 20. With the GMP approval, the company also commenced exports to Europe during the quarter. The company also exported its products to UK, Canada, Singapore, Denmark, Germany, Belgium, etc. in wake of better realisations. Besides, the company’s Custom Synthesis and CRAMS Division executed 7 new projects during H1FY11.
The company’s expansion plans are progressing within schedule. The MPII plant for Cephalosporin production at Derabassi, Punjab is expected to be commissioned by December 2010; while the Non-Beta Lactam API manufacturing plant at village Chachrauli is also expected to be commissioned by December-end, 2010.
For the six months period ended September 30, 2010 (H1FY11), the company registered an 88.75% increase in net profit at Rs. 24.82 crore compared to Rs. 13.15 crore in H1FY10. Net sales increased by 18.07% to Rs. 274.34 crore during H1FY11 as compared to Rs. 232.35 crore in H1FY10 while the EBIDTA margin registered an improvement of 208 bps over H1FY10.
Commenting on the performance, Mr. Vineet Gupta, Director, Parabolic Drugs, said, “It is encouraging to note that our diligent investments in creating a global and diversified products company have started yielding results. We have remained focused on evolving client relationships, maintaining globally benchmarked quality standards and establishing presence in a segment that offers huge potential for future growth. With the completion of the second phase of our ambitious expansion Programme by December, 2010, we would not only expand the scale of our operations but at the same time, would create substantial value for our stakeholders”.
The Board of Parabolic Drugs has also been strengthened with the appointment of Mr. Gurpreet Sandhu as a Whole time Director of the Company. Mr. Gurpreet Sandhu, an MBA in Marketing Management & International Business, having over 22 years experience in chemicals and pharmaceuticals industry. He was earlier working as Director & Head Global API Business, with Ranbaxy Laboratories Ltd.
Mr. Nikhil Goel has also joined the Board of the Company as an Independent Director. Currently, he is a Director with Avon Energy Meter Company and brings along an entrepreneurial experience of over a decade.
Parabolic Drugs Limited (PDL), a leading research based API manufacturer with stronghold in Antibiotic space and marking its presence in the Custom Synthesis and Contract manufacturing (CRAMS) segment has posted a 36.29% rise in net profit at Rs. 10.53 crore for the first quarter ended June 2010, as compared to Rs. 7.73 cr in the corresponding period of the previous year. The company’s Q1 gross Sales stood at Rs. 140.15 cr from Rs. 112.71 cr., up by 24.35% supported by launch of new Sterile Cephalosporin antibiotic API and through penetration in newer geographies. EBIDTA rose to Rs. 25.74 crore up by 52.13% as compared to Rs. 16.92 crore in the corresponding period in previous year. This was mainly due to increased share in sales of high value Cephalosporin APIs. Parabolic is extremely bullish about its estimations for FY2011.
The total income & EBIDTA margins are estimated to be Rs.705 crs & Rs. 128 crs correspondingly. The projected PAT for FY2011 is estimated to reach approximately Rs. 54 crores. Announcing the results, Mr. Vineet Gupta, Executive Director, Parabolic Drugs Ltd said “We are extremely happy with the results. We have increased our revenues mainly from newer geographies which have eventually contributed to better EBIDTA margins. Parabolic Drugs Limited is one of the fast growing API (Active Pharmaceutical Ingredients) and API intermediate manufacturing and marketing company in the SME segment, with increasing international presence and a strong R&D foundation, based at Chandigarh, India. Commissioned in 1998, PDL has two fully functional, state of the art manufacturing units, a EU - GMP certified Unit based in Derabassi (Punjab) and a manufacturing plant at Panchkula, (Haryana) approved by US FDA for supply to US respectively. Parabolic Drugs has received a Certificate of Suitability (“COS”) from the European Directorate for the Quality of Medicines (and Healthcare), France (“EDQM”) for its DMF filed for Cefuroxime Axetil Amorphous - granting permission to sell the product in the regulated markets of the European Union. Parabolic Drugs has also executed 8 custom synthesis contracts for global innovator and biotech companies since January 2010. It has signed long term sales contracts with Ranbaxy, Lindopharm Germany and Chemworth USA for the same. The Commercial production at phase I of the Chachrauli facility for manufacturing non-antibiotic products is due to start in September 2010. Company has a pipeline of 20 non-antibiotic products to be launched from this new facility.
Highlights for the quarter: -
- Got EU-GMP approval for three of its Cephalosporin manufacturing plants at Derabassi, Punjab
- Got COS (Certificate of Suitability) from EDQM for Cefuroxime Axetil Amorphous, granting permission to sell this API in EU, Registered sales in Korea and Algeria
Parabolic Drugs Limited (PDL) announced its certification of European Union for its Cephalasporin manufacturing facility in Derabassi, Punjab.
The company has received approval for three of its molecules – namely, Cefuroxime Axetil, Cefpodoxime Proxetil and Cefixime Trihydrate. This will enable the company to sell its products into Europe, Canada and Australian markets, thus giving a boost to Company’s vision of building its business in regulated markets.
Commenting on the occasion, Vineet Gupta, Executive Director, Parabolic Drugs Ltd said “Parabolic already has a USFDA approval for selling one of its products in the US markets from its Panchkula facility. With this EU-GMP certification of its Derabassi facility, PDL has expanded its sales reach in the highly regulated markets and has positioned itself as a strong API company”.
The company has a stronghold in antibiotic space and marking its presence in the Custom Synthesis and Contract manufacturing (CRAMS) segment
Gross Sales: Q4 FY10 up 35.90% to Rs. 183.78 Crores; FY10 up 30.10% to Rs.559.00 Crores
Launch of 5 new products in Cephalosporin antibiotic APIs, oral and sterile ranges
Penetration of new geographies – exports made to 45 countries in fiscal 2010
EBIDTA: Q4 FY10 EBITDA up 19.66% to Rs. 26.35 Crores; FY10 up 41.17% to Rs. 92.33 Crores. EBITDA as a percentage of Net Sales was 17.97% in FY10 as compared to 16.53% in FY09.
Launch of 4th and 5th generation Cephalosporin APIs boosted EBITDA margins
Sales to new geographies also contributed to better EBIDTA margins
Net Profit: Q4 FY10 up 105.71% to Rs. 11.52 Crores; FY10 up 42.84% to Rs. 34.20 Crores.
- Received Certificate of Suitability (“COS”) from the European Directorate for the Quality of Medicines (and Healthcare), France (“EDQM”) for its DMF filed for Cefuroxime Axetil Amorphous - granting permission to sell the product in the regulated markets of the European Union
- Executed 8 custom synthesis contracts for global innovator and biotech companies since January 2010
- Signed long term sales contracts with Ranbaxy, Lindopharm Germany and Chemworth USA
- Commercial production at phase I of the Chachrauli facility for manufacturing non-antibiotic products to start in September 2010. Company has a pipeline of 20 non-antibiotic products
- Expect total capacity expansion of 80% in the next twelve months time.
The Company’s dedicated, state of the art Research & Development Centre was inaugurated today on January 27, 2010 by honorable Mr. J. D. Gupta, retired IAS officer, Haryana Cadre at a gala function attended by dignitaries from state, financial institutions and Parabolic team.
Parabolic has taken the leap from a generic API manufacturer to being a strategic partner for Multi national companies across the world. Keeping in line with its long term vision of establishing itself in niche segments, the Company has set up a R&D centre at HSIIDC, Barwala. This centre, built over 4,200 sq. m., consists of 6 laboratories with 12 fume hoods each and separate laboratories equipped with the latest technical equipments for research work, including HPLC, Gas Chromatograph, X-Ray Diffraction system and Nuclear Magnetic Resonance, amongst others.
There is a dedicated HPLC laboratory with 20 High Performance Liquid Chromatographs controlled with a Raid-5 server, a wet lab and one laboratory for other chemical tests. There is also a dedicated Kilo Lab, built as per cGMP guidelines, for scale up of new processes developed by the R&D wing of the Company. There is an in house documentation centre and IPR and Regulatory Affairs set up. This facility is designed to house over 100 scientists and would have facilities like online library, auditorium for meetings / seminars and trainings with complete set up for web conferences, recreation room and cafeteria. All the laboratories are designed to facilitate all types of testing within this facility and the site is intended to be completely cGMP & cGLP compliant.
The technology platforms on which Parabolic R&D functions are broadly based on focused technologies and our chemistry capabilities include Chiral chemistry, Heterocyclic chemistry, Hydrogenation, etc., amongst others. Since the mission and goal of differentiating Parabolic as a Research oriented Pharma company and a partner of choice for Contract Manufacturing for innovator companies across the globe is clear, the set up of this site would be a step towards the achievement of this mission.
The Company's dedicated Cephalosporin API manufacturing Site at Derabassi has been accredited with the WHO-GMP certificate by the Central Drugs Standards Control Organization, DGHS, Ministry of Health & Family Welfare.
The Derabassi Campus, housing six manufacturing Plants, two Solvant Recovery Plants, a dedicated Quality Control and Quality Assurance unit, Research & Development wing and Administration blocks was inspected by the Central agency in September and found to be compliant with World health Organization's Good manufacturing Standards.
This WHO-GMP certificate will give further impetus to Company's API exports to countries where submission of a “Certificate of Pharmaceutical Product” i.e. COPP issued as per WHO-GMP is a preliminary requirement for marketing in that country.
The Company's Derabassi manufacturing Site has been accredited with the ISO 14001:2004 certificate for meeting the Environmental Management System Standards.
This 27 acre facility, a dedicated Cephalosporin API & intermediate manufacturing site, was audited by DNV (Det Norske Veritas) certification agency from Netherlands and found to be compliant with the highest standards of Environmental management systems.
The certification validates that all the activities on this plant related to manufacturing of API and Drug Intermediates conform to international standards of Environmental protection and that there are no harmful effluents released in the environment by the Company.
The Company has efficient waste management systems and green belts in order to avoid the impact of chemical processes taking place in the Plant on its surroundings. The certification is valid till August 2012 and will be revisited thereafter.