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API (Active Pharmaceutical Ingredients). Shilpa Medicare has been on path of expansion ever since its inception in 1987. With a regulatory recognized manufacturing set up and excellent scientific expert team in place, Shilpa Medicare has since been on a steady growth path. Currently we are one of the leaders in the Oncology market and offer a complete range of products in this segment spanning across APIs, formulations both in terms of R&D and manufacturing capabilities. Further to consolidation in field of oncology API and formulations, we are striving to put in our efforts in field of novel  

2019-07-05  Read More

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.  

2019-07-05  Read More

api manufacturers in india.Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.  

2019-05-10  Read More

Psoriasis Apremilast Tablets 10 mg, 20 mg & 30 mg.Prostate Cancer Bicalutamide Tablets 50 mg.Colorectal Cancer, Breast Cancer Capecitabine Tablets 150 mg & 500 mg. Multiple Sclerosis Dimethyl Fumarate DR Capsules 120 mg & 240 mg.Lung Cancer, Pancreatic Cancer Erlotinib Tablets 25 mg, 100 mg & 150 mg. Leukaemia, Lymphoma Ibrutinib Capsules 140 mg. Leukaemia, Gastrointestinal Stromal Tumors Imatinib Mesylate Tablets 100 mg & 400 mg.Idiopathic pulmonary fibrosis Pirfenidone Tablets 267 mg & 801 mg.Chronic constipation Prucalopride Tablets 1 mg & 2 mg  

2019-05-10  Read More

Myelodysplastic Syndrome Azacitidine for Injection 100 mg/vial. Leukaemia & Multiple Myeloma Bendamustine for Injection 25 mg/vial & 100 mg/vial. Multiple Myeloma Bortezomib for Injection 3.5 mg/vial. Bone Marrow Transplantation Busulfan Injection 6 mg/mL. Leukaemia Clofarabine Injection 1 mg/mL (20 mL fill). Leukaemia Decitabine for Injection 50 mg/vial. Breast Cancer Docetaxel injection 20 mg/ml (1, 4 & 8 mL). Breast Cancer, Ovarian Cancer, Multiple Myeloma, Kaposi's Sarcoma Doxorubicine Hydrochloride 2 mg/ml (5, 10 & 25 mL). Bladder Cancer, Pancreatic Cancer, Lung Cancer, Breast Cancer  

2019-05-10  Read More

top 10 api pharma companies in india.Research and Development The Research & Development activities at Shilpa Medicare are designed to be carried out in full compliance to sound Intellectual Property principles in vogue. The product pipeline and patent portfolio management is efficiently harmonized and overseen by the Intellectual Property Management & Legal Affairs Cell. We are committed to scale up productivity of our business continuously, marked by a quest for seeding potential opportunities, apparently latent, with speed and application as evidenced by filing close to 250 patents (applic  

2019-04-16  Read More

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.  

2019-04-16  Read More

top 10 api pharma companies in india.Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.  

2019-03-22  Read More

Shilpa Medicare Limited is managed by a well experienced group of directors, who share the passion and zeal to achieve Shilpa Medicare’s vision of “Innovating for Affordable Healthcare”. With their vast expertise in diverse sectors of pharma business, our team brings on board care, creativity, enthusiasm and commitment for achieving ‘Affordable Healthcare’ for everyone.  

2019-03-07  Read More

Human life is invaluable and we at Shilpa reiterate our respect for lives with stringent emphasis on health and safety of all our employees. In protection of the environment, we have devised rational and optimum use of our available energy resources. Though awarded by the Govt. of India with the National Energy Conservation Award 2012 (1st prize in the Drugs & Pharmaceuticals sector), our quest for professional and corporate excellence with respect for human lives, societal obligation and protection & conservation for environment is unceasing.  

2019-02-25  Read More

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Innovating for Affordable Healthcare

Shilpa Medicare is committed to put best efforts in healthcare so that every person in need has access to affordable medicines.

One of the largest Oncology Product Manufacturers

The 1st Indian company licensed to manufacture Orally Disintegrating Strips

Today, we introspect and look back with pride on the niche we have carved for ourselves in the exceedingly competitive and quality-conscious field of pharmaceuticals manufacturing.

Shilpa Medicare Limited

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

News / Events

  1. May 16, 2019: “Shilpa Medicare Limited formulation division has received U.S Food and Drug Administration final approval for its ANDA, Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL) on 16.05.2019.
    Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL is a generic equivalent of reference listed drug (RLD) TAXOTERE used in the treatment of Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, Head and Neck Cancer as recommended in the label approved by FDA.”
  2. May 15, 2019: Shilpa Medicare Ltd formulation division has received U.S Food and Drug Administration final approval for its ANDA, Zoledronic Acid Injection, 4 mg/5 mL on 15.05.2019.
    Zoledronic Acid Injection, 4 mg/5 mL is a generic equivalent of reference listed drug (RLD) ZOMETA. It is a bisphosphonate indicated for the treatment of Hypercalcemia of malignancy, Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy as recommended in the label approved by FDA.
  3. April 18, 2019: Shilpa Medicare Ltd has received U.S. Food and Drug Administration approval for its ANDA, Busulfan Injection, 60 mg/10 mL.
    Busulfan Injection, 60 mg/10 mL is a generic equivalent of reference listed drug (RLD), Busulfex Injection, 60 mg/10 mL, used in the treatment of patients with chronic myelogenous leukemia as recommended in the label approved by FDA.
  4. Feb 22, 2019: Shilpa Medicare Ltd has received U.S. Food and Drug Administration approval for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial.
    Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by FDA.
  5. Jan 17, 2019: Shilpa Medicare Ltd has received U.S. Food and Drug Administration approval for its ANDA, Imatinib Mesylate Tablets, 100 mg and 400 mg.
    Imatinib Mesylate Tablets is a generic equivalent of reference listed drug (RLD), Gleevec Tablets, 100 mg and 400 mg used in the treatment of leukemia as recommended in the label approved by FDA
  6. Dec 28, 2018: Shilpa Medicare Ltd has received U.S. Food and Drug Administration approval for its ANDA Irinotecan HCL Injection USP, 40 mg/2mL and 100 mg/5mL (20mg/mL) Single Dose Vials.Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum.
  7. 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.
  8. Nov 13, 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.
  9. Nov 13, 2018: 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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).
  14. 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.
  15. 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.
  16. Feb 11, 2016Company both Unit-1 and 100% EOU Plant (Unit-2) API Manufacturing facility at Raichur, Karnataka has received compliance letter from USFDA
  17. 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

  18. 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
  19. 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
  20. 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".

  21. 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.
  22. 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.
  23. 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.
  24. 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
  25. 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
  26. Jan 05, 2013: Shilpa Medicare bags first prize under pharma category of National Energy Conservation Award 2012
  27. Jun 12, 2013: Shilpa Medicare commences functioning partially at its facility for manufacture of formulations, near Mahaboobnagar in Telangana, India.
  28. Jun 27, 2013: Shilpa Medicare inks pact with MPP, Gilead for HIV/AIDS drugs
  29. 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
  30. May 16, 2012:Tano Capital ups stake in Shilpa Medicare Ltd.
  31. Jul 19, 2011: Shilpa Medicare has acquired controlling stake in Shilpa Therapeutics

Therapeutic Areas

Shilpa has increasingly established itself as one of few companies with integrated development, manufacturing and commercial expertise in complex sector of generic pharmaceuticals.

Research and Development

Shilpa Ltd. has evolved into a knowledge driven, R&D focused company aspiring to bring advanced, effective treatments at an affordable cost.

Manufacturing Facilities

Shilpa Medicare has five manufacturing facilities, out of which four are located in India.

Accreditations

  • FDA - Food and Drug Administration
  • GMP
  • PMDA - Pharmaceuticals and Medical Devices Agency
  • KFDA - Korean Food and Drug Administration
  • EDQM - European Directorate for the Quality of Medicines & Healthcare
  • European Union GMP
  • Canada
  • TGA - Health Safety Regulation