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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

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.

CDMO SERVICES

Shilpa Medicare provide a comprehensive service portfolio to assist researchers in applications requiring Contract Development and Manufacturing Activities.

GENERIC API

We offer high-quality intermediates cum final API products with cost-effective solutions for cutting-edge research.

GENERIC FORMULATION

Our formulation team can develop and deliver a full range of dosage forms used for treatment of various indications as per global quality standards.

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.

News / Events

  1. 27 Sep 2022 :“Shilpa’s Tranexamic Acid Spray (Hemostatic Spray) is approved by CDSCO (DCGi).”
  2. 12 July 2022 :“Shilpa Medicare Ltd, Unit VI, situated at Dabaspet, Bengaluru, Karnataka State, has been issued GMP Certificate by UK MHRA.”
  3. 26 May 2022 :“The Prestigious PEL -HEMSI AWARD presented to Polymer Research & Technology Group of Shilpa Medicare Limited .”
  4. 26 Jan 2022 :“Shilpa Medicare Limited, Unit VII (Analytical Services) situated at Nacharam, Hyderabad location has been issued NABL Accreditation.”
  5. 17 Sep 2021 :“Shilpa Medicare Ltd has received “ Best District Export Excellence Award” from FKCCI on 15th September 2021.”
  6. 31 Aug 2021 :“Shilpa Medicare Ltd. has received DCG(i) approval for 2-Deoxy-D-Glucose (Bulk & Oral Powder).”
  7. 03 Aug 2021 :“Shilpa Medicare Ltd. has launched Posaconazole Suspension with unique applicator, first of its kind highly convenient pack under the brand name “Posashil”.”.
  8. 25 June 2021 :“Shilpa Medicare has received an in-principle approval from Defence Research & Development Organisation (DRDO) to manufacture and sale of 2-Deoxy-D-Glucose (2DG). ”.
  9. 15 Jun 2021 :“Shilpa Medicare Ltd., introduces World’s First Paracetamol in Orally Disintegrating Strip ”.
  10. May 2021 :Shilpa Medicare Ltd, has received the RU GMP certificate from the Russian MOH”.
  11. May 2021 :Shilpa Biologicals Pvt Ltd, (SBPL) the wholly owned subsidiary of Shilpa Medicare Ltd. has entered in a 3-year definitive agreement with Dr. Reddy's Laboratories for the production-supply of Sputnik V vaccine”.
  12. April 26 2021 : Shilpa Pharma, Inc. Sues Novartis Pharmaceutical Corporation for Patent Infringement for “Fingolimod Polymorph and Their Processes”.
  13. March 3 2021 : “Shilpa Medicare Ltd., has launched India’s first women intimate cleansing spray under the brand name “Swatchshil”. “SwatchShil” intimate Cleansing Spray is a Soap-free and alcohol-free solution with a pH of 3.7± 0.5, ideal for the Women intimate area, helps in maintaining the optimum pH level and avoids vaginal discomfort and effectively maintain intimate hygiene. ”
  14. Feb 15 2021 : Shilpa Medicare Ltd has launched Sunitinib Capsules 12.5 mg, 25 mg & 50 mg in Indian market under brand name “SUNISHIL”. Sunitinib Capsules are indicated for the treatment of Gastrointestinal stromal tumour (GIST), Metastatic renal cell carcinoma (MRCC) & Pancreatic neuroendocrine tumours (pNET). SUNISHIL is a therapeutic equivalent of the brand leader SUTENT.
  15. Feb 12 2021 : Shilpa Medicare Limited has launched Dimethyl Fumarte Delayed Release Capsules 120 mg & 240 mg in India under the brand name “DMFShil”. Shilpa’s DMFShil is a therapeutic equivalent of TECFIDERA (brand leader). DMFShil is used in the treatment of Relapsing remitting multiple sclerosis.
  16. Aug 26 2020 : Shilpa Medicare Limited has successfully launched Azacitidine 25 mg/ml powder for suspension for injection in Europe through its partners. Azacitidine 25 mg/ml powder for suspension for injection is a generic equivalent of VIDAZA (brand leader) approved for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with myelodysplastic syndromes, chronic myelomonocytic leukaemia & acute myeloid leukaemia.
  17. Aug 26 2020 : Shilpa has successfully launched for the first time in the world, ready to drink “Green Tea Film”. Shilpa's Green Tea film contains 120 mg of green tea extracts with 98% Polyphenol content.
  18. June 30 2020 : Shilpa Medicare Limited launches the first Indian branded generic of Axitinib Tablets 1 mg & 5 mg, an anti-cancer drug with a brand name AXISHIL. AXISHIL is used to treat patients with ‘First-Line Advanced Renal Cell Carcinoma’ and ‘Second-Line Advanced Renal Cell Carcinoma’.
  19. June 2 2020 : Shilpa Medicare Limited launches the Indian branded generic of Ibrutinib Capsules 140 mg, an anti-cancer drug with a brand name IBRUSHIL. IBRUSHIL is used to treat patients suffering from Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphomas (MCL) and other related cancers. Shilpa’s IBRUSHIL is the generic equivalent & bioequivalent of the brand leader IMBRUVICA.
  20. May 23 2020: Shilpa Medicare Limited has received CDSCO -New Delhi Permission for manufacturing and marketing of Lenvatinib capsules 4mg and 10mg in India. Shilpa Medicare Limited is the “First Company” to obtain Generic approval for Lenvatinib Capsules 4mg and 10mg in India.
  21. April 12 2020: Shilpa Medicare Limited has launched first branded generic anti-cancer drug, Dasatinib with all dosage strengths 20 mg, 50 mg, 70 mg & 100 mg under brand name – DASASHIL. The drug substance patent on Dasatinib was owned by Bristol-Myers-Squibb and was expired on 12 April 2020.
  22. Jan 13 2020: Shilpa’s Formulation (Oral Solids & Injections) manufacturing facility located at Jadcherla, Telangana, has been issued EU GMP certificate by AGES, Austria for the inspection done during 13 to 17 Jan 2020.
  23. Fab 07 2020: Shilpa Medicare Limited has successfully completed USFDA inspection at both API sites located at Raichur (Unit-1 & Unit-2) between 3rd and 7th Feb, 2020 with ZERO 483s.
  24. Jan 30 2020: Shilpa Medicare Limited has received U.S Food and Drug Administration tentative approval for its ANDA, Pirfenidone Tablets, 267 mg and 801 mg on 30 Jan 2020. The ANDA is filed as ‘First to File’ submission on NCE -1 date.
    Pirfenidone Tablets, 267 mg and 801 mg is a generic equivalent of reference listed drug (RLD) Esbriet Tablets, 267 mg and 801 mg, of Hoffmann La Roche Inc. used in the treatment of idiopathic pulmonary fibrosis as recommended in the label approved by FDA.
  25. Aug 08 2019: “Shilpa Medicare Limited has received CEP from EDQM for Tranexamic Acid (R0-CEP 2018-048-Rev 00.)”
  26. 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.”
  27. 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.
  28. 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.
  29. 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.
  30. 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
  31. 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.
  32. 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.
  33. 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.
  34. 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.
  35. 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.
  36. 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.
  37. 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.
  38. 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).
  39. 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.
  40. 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.
  41. Feb 11, 2016Company both Unit-1 and 100% EOU Plant (Unit-2) API Manufacturing facility at Raichur, Karnataka has received compliance letter from USFDA
  42. 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

  43. 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
  44. 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
  45. 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".

  46. 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.
  47. 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.
  48. 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.
  49. 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
  50. 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
  51. Jan 05, 2013: Shilpa Medicare bags first prize under pharma category of National Energy Conservation Award 2012
  52. Jun 12, 2013: Shilpa Medicare commences functioning partially at its facility for manufacture of formulations, near Mahaboobnagar in Telangana, India.
  53. Jun 27, 2013: Shilpa Medicare inks pact with MPP, Gilead for HIV/AIDS drugs
  54. 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
  55. May 16, 2012:Tano Capital ups stake in Shilpa Medicare Ltd.
  56. Jul 19, 2011: Shilpa Medicare has acquired controlling stake in Shilpa Therapeutics

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