FAQs

Shilpa Medicare Limited is a leading Indian pharmaceutical company specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs), finished dosage formulations, and novel drug delivery systems. We serve global markets with a strong focus on oncology and non-oncology products, backed by world-class manufacturing facilities and regulatory approvals from major international authorities including USFDA, EU GMP, and WHO-GMP.

Shilpa Medicare operates 6 state-of-the-art manufacturing facilities across India: Unit I & II (Shilpa Pharma Life Sciences) for API manufacturing in Raichur; Jadcherla Unit (Unit IV) for finished dosages in TSIIC Pharma SEZ; Shilpa Therapeutics in Hyderabad for oral thin films; Unit VI for transdermal patches and oral thin films; and Unit VII Nacharam housing analytical and bioanalytical laboratories. Combined, these facilities span over 100 acres with advanced infrastructure and multiple international regulatory approvals.

Our facilities hold approvals from major global regulatory authorities including USFDA, EU GMP, WHO-GMP, TGA (Australia), PMDA (Japan), KFDA (South Korea), TPD (Canada), ANVISA (Brazil), COFEPRIS (Mexico), and DIGEMID (Peru). We also maintain ISO certifications including ISO 14001 (Environmental Management), ISO 45001 (Occupational Health & Safety), and ISO 50001 (Energy Management), ensuring compliance with the highest international standards.

We specialize in complex pharmaceutical manufacturing across multiple domains: high-potency APIs including oncology compounds, peptides and biologics, novel drug delivery systems (transdermal patches and oral thin films), finished dosage formulations (oral solids and injectables), and contract research and manufacturing services (CRAMS). Our technical expertise includes asymmetric synthesis, chiral technology, and advanced containment systems for potent compounds.

We manufacture a comprehensive range of APIs including oncology APIs (cytotoxic and targeted therapies), non-oncology APIs across various therapeutic categories, peptides and complex molecules, high-potency APIs with advanced containment, and chiral compounds with asymmetric synthesis capabilities. Our facilities have a combined reactor capacity of over 240,000 liters across oncology and non-oncology blocks, enabling large-scale commercial production.

Yes, we provide comprehensive CDMO (Contract Development and Manufacturing Organization) services including API synthesis from route scouting to commercial scale, formulation development for oral solids and injectables, scale-up and technology transfer, regulatory support and documentation, and analytical method development and validation. Our Jadcherla and other facilities are specifically equipped for contract manufacturing with flexible production capabilities.

Transdermal patches are advanced drug delivery systems designed to deliver medication systemically through the skin. They consist of a polymeric adhesive matrix containing the drug, sandwiched between a backing film and release liner. Key advantages include avoiding hepatic first-pass metabolism for better bioavailability, sustained drug delivery reducing dosing frequency, decreased pill burden improving patient compliance, and self-administration ideal for elderly or multiple-medication patients. Our Unit VI manufactures 40 million TDS products annually.

Oral Thin Films are innovative drug delivery systems composed of polymeric matrices that dissolve rapidly in the mouth. We manufacture two types: Orodispersible films that dissolve within seconds and are swallowed with saliva (similar to tablets), and Transmucosal films where the active ingredient enters systemic circulation via buccal mucosa, avoiding hepatic first-pass effect. OTFs offer improved patient compliance, especially for pediatric and geriatric patients, and faster onset of action compared to conventional tablets.

Our Unit VII Nacharam houses comprehensive analytical services including method development and validation, raw material and finished product testing, stability studies and shelf-life determination, and physiological compatibility studies. The bioanalytical laboratory offers GLP-compliant services for therapeutic drug monitoring (TDM), pharmacokinetic (PK) studies for BA/BE trials, complex assay development for chiral compounds, metabolites, and proteins, and LC-MS/MS analysis with capacity for 20,000 samples per month. We support oncology, non-oncology injectables, oral dosage forms, and novel drug delivery systems.

Quality is embedded in our operations through comprehensive cGMP compliance across all facilities, state-of-the-art quality control laboratories with advanced instrumentation, validated manufacturing processes with electronic batch records, regular internal and external audits by global regulatory authorities, dedicated quality assurance teams at each facility, and continuous improvement programs and employee training. All facilities operate under stringent quality management systems aligned with international standards.

We maintain multiple quality certifications including cGMP compliance across all manufacturing sites, ISO 14001:2015 for Environmental Management Systems, ISO 45001:2018 for Occupational Health & Safety Management, ISO 50001:2011 for Energy Management Systems, GLP certification for bioanalytical laboratory, and NABL accreditation for analytical testing. Our facilities are regularly inspected and approved by USFDA, EU GMP, and other international regulatory bodies.

Yes, our products are available in multiple international markets. As a 100% Export Oriented Unit (Unit II), we are specifically designed to serve global pharmaceutical companies. Our products are exported to regulated markets including the United States, European Union, Australia, Japan, South Korea, Canada, Brazil, Mexico, Peru, and other countries. We work with pharmaceutical companies worldwide to supply high-quality APIs and finished dosage forms meeting their specific regulatory requirements.

Sustainability is core to our operations through ISO 14001:2015 certified Environmental Management Systems, ISO 50001:2011 Energy Management Systems for efficiency, advanced waste treatment and recycling facilities, green chemistry practices in API synthesis, water conservation and recycling programs, and renewable energy initiatives. Our facilities are designed with environmental responsibility in mind, and we continuously invest in sustainable technologies and practices.

Yes, research and development is a key focus area. We operate multiple R&D centers specializing in process chemistry and route optimization, formulation development for novel delivery systems, analytical method development, scale-up technologies, and regulatory sciences. Our DSIR-approved R&D facilities work on developing new APIs, improving existing processes, and creating innovative drug delivery solutions. We have expertise in complex chemistry including chiral synthesis, peptide chemistry, and high-potency compound handling.

Shilpa Therapeutics is a subsidiary of Shilpa Medicare Limited specializing in oral fast dissolving thin strip dosage forms using proprietary Fast Disintegration Technology. The facility has a production capacity of 800,000 units per day with an 8-track packing machine. Their first launched product, Ondansetron oral disintegrating strips, has received excellent response from patients and prescribers across India. Visit www.shilpatherapeutics.com for more information.

You can reach us through multiple channels: Visit our Contact page for office locations and contact forms, email us at info@shilpamedicare.com, or call our main office. For specific inquiries about business development, regulatory affairs, or career opportunities, please use the contact forms available on our website to reach the relevant department.

Yes, we regularly recruit talented professionals across various functions including manufacturing, quality assurance, R&D, regulatory affairs, business development, and support services. Please visit our Careers section to view current openings and submit your application. We value skilled, dedicated professionals and offer growth opportunities in a world-class pharmaceutical manufacturing environment.

Pharmaceutical companies can partner with us for contract manufacturing, API supply agreements, formulation development services, analytical and bioanalytical testing, regulatory support and documentation, and technology transfer projects. Our business development team works closely with clients to understand requirements and provide customized solutions. Contact our business development team through the website or reach out to discuss partnership opportunities.