MARKET Management, Amneal Pharmaceutical, Dr Deepak Haldankar, Vice President, Corporate Quality, Sun Pharmaceutical Industries, Dr PV Kanitkar, Director, Plant Operations, Pfizer, Hemant Narwekar, Head, QA, Cipla, Dr Sanjay Shetgar, Vice President, Operations, Quality Global Generics, Dr Reddy’s Laboratories, Manu Grover, Assistant Product Manager, Waters India, Shaun Quinn: ChromeleonSoftware Product Specialist, Networking and Compliance (Thermo Scientific), Saroj Patnaik, Global Director, Emerson Life Sciences (Emerson Process Management), Venkata Ramana, General Manager, CQA & Head, Com-
A panel-discussion on business and process automation: an integral part of regulatory compliance was lead by significant individuals from the companies present at the conference
puter System Compliance, Ranbaxy Laboratories. Concerned research analysts/ correspondents were
present to interview the speakers anddelegates. Cipla, Glaxosmithkline Pharmaceuticals, Johnson & Johnson,
Kemwell Biopharma, Perrigo Laboratories India, Piramal Enterprises, Ranbaxy Laboratories, Teva Pharm India, Watson Pharma, Wockhardt and Thomson Reuters took part in the conference. The conference was consecrated by the directors of Alliance India, Brian Nunes and Faisal Sheikh who accompanied Dr Deepak Haldankar and the chairman of the event Ranjit Barshikar to light the lamp. Barshikar began with his updates on US FDA inspection guidelines. The chief guest, Mahesh Zagade shared his impulsive and well informed notion on the latest indian regulatory requiremnts/ changes.
A panel-discussion on business and process automation: an integral part of regulatory compliance was lead by significant individuals from the companies present at the conference. Adkisson stood out as an empowering speaker post his intense impartation on ways to resolve data integrity issues. Dr Ajaz Hussain addressed the crowd on data integrity concerns. His humility to have agreed to do so was not only overwhelming, but appreciated by the crowd’s utmost diligence during his presentation. The conference was concluded by Barshikar and Nunes. EP News Bureau - Mumbai
AZITHROMYCIN
34-year history of partnership with leading pharma companies
active pharmaceutical ingredients & its intermediates*
Commercial scale Antitubercular
Macrolides
Antihypertensive
Antiretroviral
Pyrazinamide# * Isoniazid # *
Azithromycin Clarithromycin Erythromycin base # Erythromycin estolate # Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #
Irbesartan # Losartan potassium Telmisartan Valsartan
Ganciclovir Valaciclovir Valganciclovir Maraviroc
Sedative, Hypnotic
Antidiabetic
Antifungal
Linagliptin Vildagliptin
Antihistaminic
Flucytosine #
Hypnotic
Antimalarial Artesunate Arteether Artemether # * Dihydroartemisinin Lumefantrine # * Piperaquine
Antiosteoporotic Alendronate sodium Zoledronic acid US DMF
Under Development
*
WHO APIMF
CEP / COS
#
Cetirizine dihydrochloride # Hydroxyzine dihydrochloride Meclizine dihydrochloride+
#
Zopiclone
#
APProVED
Antiepileptic
Eszopiclone
Valproic acid
Antithrombotic
#
Antidepressant
Clopidogrel bisulphate
Venlafaxine hydrochloride
CTD ling under process
*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility rest with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.
Calyx Chemicals and Pharmaceuticals Limited Reg. Office: Unit No.110, Marwah's Complex, Krishanlal Marwah Marg, Off. Saki Vihar Road, Andheri (East), Mumbai – 400072, Maharashtra, India. Tel: +91-22-28571191, Fax: +91-22-66466416, Email: sales@calyxindia.com, crams@calyxindia.com USA Contact : 11728 E. Imperial Highway, Norwalk, CA 90650, Tel - 213-291-7773, Email: sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com
"Calyx Chemicals and Pharmaceuticals Limited (the “Company”) is proposing to make, subject to receipt of requisite approvals, market conditions and other considerations, an Initial Public Offering of its equity shares (the “IPO") and has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com and YES Bank Limited at www.yesbank.in and is also available on the website of the Company at www.calyx-pharma.com. Potential investors should note that investment in equity shares involves a degree of risk. For details, please refer to the DRHP, including the section titled “Risk Factors” of the DRHP. This publicity material does not constitute an offer of securities in any jurisdiction, including the United States of America (“USA”). Securities may not be offered or sold in the USA without registration under the U.S. Securities Act of 1933 as amended, or an exemption therefrom. The Company has not and does not intend to offer any securities to the public in the USA”.
47 EXPRESS PHARMA November 16-30, 2013