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Press Releases

Nov 13, 2018 : • Shilpa Medicare Limited’s ANDA (#210291) for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg has been granted tentative approval by FDA on November 09, 2018.
• Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg is a generic of TECFIDERA, used in the treatment of patients with relapsing forms of multiple sclerosis.
• This ANDA is a first to file submission made on NCE-1 date Mar 27, 2017. FDA review process was completed and got approval within a period of 19.5 months from the date of submission.

Oct 10, 2018: Koanaa Healthcare Limited an European Subsidiary of Shilpa Medicare got approval in Czech Republic for Shilpa’s Pemetrexed for injection 100 mg & 500 mg/vial Pemetrexed is used in the treatment of Malignant pleural mesothelioma & Non-small cell lung cancer.
Country Approval Date MAH MA Status MA Number
CZ 10-Oct-18 KHC, AT Approved 44/597/16-C, 44/598/16-C
Oct 2, 2018: Koanaa Healthcare Limited an European Subsidiary of Shilpa Medicare got approval in Estonia for Shilpa’s Pemetrexed for injection 100 mg & 500 mg/vial Pemetrexed is used in the treatment of Malignant pleural mesothelioma & Non-small cell lung cancer.
Country Approval Date MAH MA Status MA Number
EE 02-Oct-18 KHC, AT Approved 973118, 973218
Sep 4, 2018: Koanaa Healthcare Limited an European Subsidiary of Shilpa Medicare got approval in Malta for Shilpa’s Pemetrexed for injection 100 mg & 500 mg/vial Pemetrexed is used in the treatment of Malignant pleural mesothelioma & Non-small cell lung cancer.
Country Approval Date MAH MA Status MA Number
MT 04-Sep-18 KHC, AT Approved MA1280/00101, MA1280/00102

June 15, 2018:Shilpa Medicare Limited bagged the most prestigious Export Excellence Award on 15th June 2018 in recognition of the company's exemplary services in the export segment by Federation of Karnataka Chambers of Commerce and Industry (FKCCI).

July 18 to July 26, 2016 : • Formulation facility audited by USFDA from July 18 to July 26 and audit was successfully completed with Zero 483s.
• Both Raichur API facility (Unit-1 and unit-2) received GMP clearance from TGA - Australia
• Raichur API facility Unit-1 received GMP clearance from PMDA - Japan.

April 18, 2016: Our MD, Mr. Vishnukant Bhutada, is ranked # 35 as "India's Most Valuable CEO" in Mid-Size Companies Category (Sales between 250 Cr - 2,499 Cr) by Business World, a reputed business publication in India.

Feb 11, 2016Company both Unit-1 and 100% EOU Plant (Unit-2) API Manufacturing facility at Raichur, Karnataka has received compliance letter from USFDA

Nov 30, 2015 "Shilpa Medicare Ltd bagged UBM's "Excellence in R&D" Award (Company with turnover more than 500 Cr)."
The Award was presented during the "India Pharma Awards 2015" Function at Mumbai on 30th November 2015. Read More

Oct 02, 2015 EUGMP received from Government of Upper Bavaria, Germany for Gemcitabine, Irinotecan HCL, Oxapplatin and Temozolomide to our Unit-1 at Raichur, Karnataka."
The plant was inspected by authority on 8th July 2015. Read More

Oct 09, 2015 EUGMP received from Government of Upper Bavaria, Germany for Bendamustine, Capecitabine and Melphalan to our Unit-2 at Raichur, Karnataka".
The plant was inspected by authority on 8th July 2015. Read More

Sep 23, 2015: Shilpa Medicare Ltd bagged Pharmexcil's "Patent Award" for securing the most number of product patents. The Awards were presented during the "Awards Function for Exports and patents during 11th Annual General Meet of Pharmexcil at Hyderabad".

Sep 08, 2015: Company 100% EOU Plant at Raichur, Karnataka has received GMP compliance from authority of Switzerland, Swissmedic for manufacturing of active substance Ambroxol Hydrochloride for three years.
The plant was inspected by authority between 18th March 2015 to 20th March 2015.

Aug 28, 2015: Company SEZ Formulation unit at Jadcherla (Near Hyderabad), Telengana received GMP certification for both Human Medicinal Products & Human Investigational Medicinal Products from Republic of Slovenia.
The Jadcherla plant was inspected on 19-11-2014 by the Authorities.

Aug 28, 2015: Company 100% EOU Plant at Raichur, Karnataka has received certification for CEP 2004-201 Ambroxol Hydrochloride.
The Raichur plant was inspected by European Directorate for the Quality of Medicines & Healthcare (EDQM) on 18-03-2015 to 20-03-2015.

Dec 19, 2014: Shilpa Medicare has benchmarked its quality processes against the world's best quality standards in various areas of operation. 1) ISO 9001:2008 for Quality Management System for SML unit-1 for period 13-12-2014 to 12-12-2017 and SML unit-2 100% EOU for period 09-12-2014 to 08-12-2017. 2) ISO 14001:2004 for Environment Management System for SML unit-1 for period 13-12-2014 to 12-12-2017 and SML unit-2 100% EOU for period 09-12-2014 to 08-12-2017. 3) Cofepris GMP Certificate, Mexico for Ambroxol, Nifedipine and Gemcitabine

Sep 25, 2013: Shilpa Medicare observed Pharmacist's day in Raichur, Karnataka in collaboration with N.E.T Pharmacy College and V.L. College of Pharmacy.

Jan 05, 2013: Shilpa Medicare bags first prize under pharma category of National Energy Conservation Award 2012

Jun 12, 2013: Shilpa Medicare commences functioning partially at its facility for manufacture of formulations, near Mahaboobnagar in Telangana, India.

Jun 27, 2013: Shilpa Medicare inks pact with MPP, Gilead for HIV/AIDS drugs

Sep 28, 2012:Hon'ble High Court of Andhra Pradesh has approved the scheme of amalgamation of Raichem Life Sciences Private Limited with Shilpa Medicare Ltd.

May 16, 2012:Tano Capital ups stake in Shilpa Medicare Ltd.

Jul 19, 2011: Shilpa Medicare has acquired controlling stake in Shilpa Therapeutics