Shilpa Pharma Lifesciences Limited (SPLL) is a wholly owned subsidiary of Shilpa Medicare Limited (SML) that was established in 1987 with headquarters in Raichur, Karnataka. The Parent company is a publicly listed company listed on the Mumbai stock exchange. Over the years, we have emerged as one of the largest manufacturers of oncology APIs and formulations from Asia.

We are fully integrated covering early phase and late phase DS and DP development and cGMP manufacturing with facilities located across Ahmedabad, Hyderabad, Bengaluru and Dharwad and approvals from global regulatory agencies such as USFDA, Health Canada, EMA, PMDA, KFDA, Cofepris, TGA and others. We bring 30+ years of experience in pharmaceutical R&D and are your trusted fully regulatory grade partner for development and GMP/non-GMP manufacturing of small molecules, large molecules as well as segments such as specialty chemicals, performance materials and polymers. More details are provided below -

Small molecules – Non-oncology and oncology, high potent and cytotoxic compounds (advanced intermediates, RSMs and API) spanning custom synthesis, chemical development, clinical materials, scale-up and commercial scale production with multi-metric ton capacities, incl., specialized expertise in flow chemistry. We are oncology specialists and bring significant experience in the development and manufacturing of TKIs such as Axitinib, Dasatinib, Erlotinib, Imatinib, Lenvatinib, Nilotinib, Pazopanib, Sorafenib, Sunitinib and others, and a range of anti-cancer compounds such as Bortezomib, Cabazitaxel, Capecitabine, Decitabine, Enzalutamide, Gemcitabine, Pomalidomide, Temozolomide, to name a few.

Biologics – Fully equipped with upstream and downstream capabilities for both microbial and mammalian fermentation for the production of MAbs, fusion proteins and ADCs. Our expertise stems from extensive hands-on development of molecules such as recombinant human albumin, adalimumab, etanercept, aflibercept and abatacept, to name a few. We also bring expertise in the design of adenoviral and AAV based gene therapies as well as vaccine manufacturing (e.g., from HEK293 and E. coli for Covid-19 and high purity DNA plasmids for mRNA vaccines). We provide the full complement of services from clone development and cGMP cell banking to manufacturing, fill/finish (in vials and PFS), packaging and labeling, and can enter the value chain at any point to offer standalone services, as necessary.

Therapeutic peptides – Development from simple di-peptides to ~100 aa residues, and scale from milligram to 100s of kg. Our facilities are led by a seasoned team and are equipped with technologies such as solution phase chemistry, solid phase using Fmoc and t-Boc methodologies as well as microwave synthesizers that offer exquisite savings in time and cost while delivering exceptional purity and quality. This is supported by full in-house analytical infrastructure (NMR, QTOF, LCMS, GCMS and UPLC, …). Representative examples of our work include peptides containing disulfide linkages such as Eptifibatide, Vasopressin, Desmopressin and Octreotide and a range of peptides for use in oncology (Degarelix and Leuprolide) and non-oncology indications (e.g., Calcitonin, Ganirelix, Glucagon, Icatibant, Teriparatide, Teduglutide). To complete the picture, we can deliver on both early and late phase as programs progress through the pipeline incl., formulation development and fill-finish (e.g., Desmopressin Acetate Sublingual Tablets and Injection, Liraglutide Injection, Vasopressin Injection, to name a few).

Specialty polymers – Development of biopolymers, PEGylation chemistry (incl., high MW pegylations), application of poly(butadiene)-b-poly(ethylene oxide) for controlled drug release as well as a range of capabilities in development of derivatives (e.g., functionalization of polybutadienes, and other polymers) and can deliver high quality and cost-effective products at any commercial scale from our USFDA approved facilities.

Formulations – Decades of expertise developing a range of dosage forms e.g., orals, ophthalmics, injectables, suspensions, topicals, incl., novel or extended-release formats such as oral thin films and transdermal patches as well as complex systems such as nanoparticle, liposomal and lyophilized products.