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Shilpa Medicare – complex molecules into medicines

Dr. Clot Tranexamic Acid Spray – setting a new standard in rapid hemostatic care
  • 39+

    Years of excellence

  • 10+

    Regulator-approved facilities

  • 50+

    Countries served

  • 70+

    Commercial APIs

Our core services

Fully integrated, from molecule to market.

From early development to commercial supply, Shilpa provides fully integrated pharmaceutical solutions — combining deep scientific expertise, robust quality systems and global regulatory experience.

All capabilities
01 / 04 Small molecules

Active Pharmaceutical Ingredients

70+ commercial APIs across oncology, immunology, neurology, cardiovascular, respiratory and specialty therapeutic areas.

  • Two US FDA-inspected sites in Raichur, Karnataka
  • ~1,160 KL combined reactor capacity across 21 blocks
  • High-containment suites for cytotoxic and high-potency molecules
Explore APIs
02 / 04 Formulations

Complex Finished Dosage Forms

Oral solids, sterile injectables, oral dissolving films, transdermal patches, oral suspensions, topicals and novel drug delivery.

  • High-potency oncology injectables and lyophilised formulations
  • Oral dissolving films and controlled-release transdermal patches
  • Portfolio weighted toward complex, difficult-to-replicate products
Explore formulations
03 / 04 Large molecules

Biologics

EU-GMP certified biologics campus at Dharwad, spanning cell line development through to fill-finish.

  • Mammalian and microbial upstream processing
  • Integrated antibody-drug conjugate (ADC) drug-substance facility
  • Biosimilar pipeline across oncology, immunology and ophthalmology
Explore biologics
04 / 04 Partnerships

CDMO Services

End-to-end contract development and manufacturing across small molecules, peptides, complex dosage forms and biologics.

  • Route scouting to commercial scale-up
  • HPAPI / cytotoxic capabilities (OEL 1–5)
  • Support across pre-clinical, clinical and commercial phases
Explore CDMO
The Shilpa Medicare team

Since 1987

39+

Years of pharmaceutical excellence

From a single API plant in Raichur to a diversified global pharma company.

Since 1987, Shilpa Medicare has evolved from a single API facility in Raichur, Karnataka into a diversified pharmaceutical company with integrated strengths across development, manufacturing and commercialisation.

Our story
  • Global reach

    Supplying APIs, formulations and oncology products to 50+ markets worldwide.

  • Quality assurance

    US FDA, EU GMP and other global health authority approvals underpin our quality systems.

  • R&D innovation

    Four dedicated R&D centres driving innovation in APIs, formulations, biologics and novel delivery platforms.

Research & development

Investing in science. Innovating for patients.

Our R&D centres focus on complex generics, oncology APIs, biologics, peptides and advanced delivery systems. By combining deep chemistry, biology and engineering capabilities, we bring difficult-to-make products to market faster — without compromising on quality or patient safety.

Discover our R&D

Focus areas

  1. 01Complex generics
  2. 02Oncology APIs
  3. 03Biologics
  4. 04Peptides
  5. 05Advanced drug delivery

Global accreditations

Inspected and approved by the world’s toughest regulators.

Our facilities are inspected by leading global health authorities, reflecting our commitment to quality and compliance.

  • USFDAUnited States
  • EDQMEurope
  • EU GMPEuropean Union
  • Health CanadaCanada
  • ANVISABrazil
  • TGAAustralia
  • WHO GMPGlobal
  • PMDAJapan

Quality management certifications

Independently audited systems for quality, safety, environment, energy and social accountability.

5 Global management standards held
  • ISO 9001 Quality Management 2015 Certified
  • ISO 14001 Environmental Management 2015 Certified
  • ISO 45001 Occupational Health & Safety 2018 Certified
  • ISO 50001 Energy Management 2018 Certified
  • SA 8000 Social Accountability Certified

Newsroom

Recent achievements

Milestones that showcase our commitment to pharmaceutical innovation and excellence.

All news

UK MHRA Certificate

GMP Certification

GMP Certificate issued by UK MHRA for our Dabaspet manufacturing facility.

Export Excellence Award

FKCCI Recognition

Best District Export Excellence Award recognising our global market contribution.

FAQ

Questions partners often ask.

Can’t find what you’re looking for? Our business development team will get back to you within two working days.

Ask a question
01 What does Shilpa Medicare do?

We develop and manufacture active pharmaceutical ingredients, complex finished dosage forms and biologics, and offer end-to-end CDMO services — from early development to commercial supply.

02 Which regulators have inspected your facilities?

Our facilities are inspected by leading global health authorities including USFDA, EDQM, EU GMP, Health Canada, ANVISA, TGA and WHO GMP, and we hold a GMP certificate from UK MHRA for our Dabaspet site.

03 Do you handle high-potency and cytotoxic molecules?

Yes. We operate high-containment suites for cytotoxic and high-potency molecules with HPAPI capabilities across OEL 1–5.

04 Where are your manufacturing sites?

Our API sites are in Raichur, Karnataka, our EU-GMP certified biologics campus is in Dharwad, and our formulations facility is at Dabaspet.

05 How do I start a CDMO or supply partnership?

Send us a short brief through the contact page. Our business development team will set up a confidential discussion, typically under an NDA.

Let’s build the next difficult-to-make medicine together.

Talk to our team about APIs, complex formulations, biologics or a CDMO programme.