Global Oncology API Solutions
Leading API Manufacturers and Suppliers in India
Oncology / Non-Oncology API Manufacturer in India
At Shilpa Pharma, we are the trusted pharma manufacturing partner behind many of the world’s leading pharmaceutical brands. With state-of-the-art facilities approved by USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, and KFDA, we deliver APIs that meet the most stringent international quality and regulatory standards. Our reputation is built on confidentiality, scientific innovation, and consistent excellence, ensuring every molecule we produce upholds the trust of global healthcare leaders.
As a full-scale Contract Development and Manufacturing Organization (CDMO) in India, we offer end-to-end solutions, from R&D and process development to commercial-scale API production. When top pharmaceutical companies need reliability, precision, and compliance, they choose Shilpa Pharma. Backed by decades of expertise and a diverse API portfolio across oncology, cardiovascular, CNS, antiviral, and other therapeutic areas, we help our partners bring safe and effective medicines to market faster.
Committed to supporting global markets, Shilpa Pharma provides comprehensive regulatory documentation, IPR assistance, and adherence to international quality standards. By combining cutting-edge R&D capabilities with a worldwide supply network, we deliver safe, effective, and reliable API solutions, making us a preferred partner for pharmaceutical companies around the globe.
Partner with Shilpa Pharma, the brand global pharma trusts to manufacture with integrity, quality, and world-class performance.
Complete Range of Active Pharmaceutical Ingredients
| Product Name | CAS Number | Mol. Wt | Grade | DMF Availability | View Product |
|---|---|---|---|---|---|
| Abiraterone Acetate | 154229-18-2 | 391.55 | USP | Yes | View Product |
| Ambroxyl Hydrochloride | 23828-92-4 | 414.57 | EP | Yes | View Product |
| Amifampridine Phosphate | 446254-47-3 | 207.12 | In-house | Yes | View Product |
| Apalutamide | 956104-40-8 | 477.43 | - | - | View Product |
| Axitinib | 319460-85-0 | 386.47 | In-house | Available | View Product |
| Azacitidine | 320-67-2 | 244.2 | USP | Available | View Product |
| Bendamustine Hydrochloride | 3543-75-7 | 394.72 | USP | Available | View Product |
| Bicalutamide | 90357-06-05 | 430.37 | EP/USP | Available | View Product |
| Bortezomib | 90357-06-05 | 384.24 | In-house | Available | View Product |
| Busulfan | 55-98-1 | 246.3 | USP and EP | Available | View Product |
| Cabazitaxel | 55-98-1 | 835.93 | In-house | Available | View Product |
| Canagliflozin Hemihydrate | 928672-86-0 | 453.53 | View Product | ||
| Capecitabine | 154361-50-9 | 359.35 | USP and EP | Available | View Product |
| Clofarabine | 123318-82-1 | 303.68 | In-house | Available | View Product |
| Cyclophosphamide | 50-18-0 | 278.04 | USP and EP | Available | View Product |
| Dasatinib | 302962-49-8 | 488.01 | In-House | Available | View Product |
| Dimethyl Fumarate | 624-49-7 | 144.13 | USP | Available | View Product |
| Edoxaban Tosylate Monohydrate | 1229194-11-9 | 738.27 | In-house | NA | View Product |
| Encorafenib | 1269440-17-6 | 540.01 | API (EP/USP) | NA | View Product |
| Exatecan Mesylate | 197720-53-9 | 567.58 g/mol. | In-house | NA | View Product |
| Fingolimod Hydrochloride | 162359-56-0 | 343.93 | USP and EP | Available | View Product |
| Imatinib Mesylate | 220127-57-1 | 589.71 | USP / EP | Available | View Product |
| Irinotecan Hcl | 136572-09-3 | 677.18 | USP and EP | Available | View Product |
| Irinotecan Hydrochloride Trihydrate | 136572-09-3 | 677.18 | USP and EP | Available | View Product |
| Lenalidimide | 191732-72-6 | 259.3 | In-house | Form-A Available, Form-B (under process) | View Product |
| Lenvatinib Mesylate | 857890-39-2 | 522.96 | In-house | Available | View Product |
| Melphalan Hydrochloride | 3223-07-02 | 341.66 | USP/IH | Available | View Product |
| Methotrexate | 59-05-2 | 454.44 | API (EP/USP) | Available | View Product |
| Methotrexate Disodium | 7413-34-5 | 498.41 g/mol | In-house | Available | View Product |
| Nifedipine | 21829-25-4 | 346.33 | USP/EP | Available | View Product |
| Nilotinib | 641571-10-0 | 529.52 | In-house | Available | View Product |
| Olaparib | 763113-22-0 | 434.471 g/mol | API (USP/EP) | Available | View Product |
| Orforglipron Hemicalcium Hydrate | 3008544-96-2 | 921.02 | NA | NA | View Product |
| Osimertinib | Osimertinib: [1421373-65-0] Osimertinib mesylate: [1421373-66-1] | Osimertinib: 499.61 g/mol Osimertinib mesylate: 596 g/mol | API (EP/USP) | NA | View Product |
| Oxaliplatin | 61825-94-3 | 397.29 | USP/EP | Available | View Product |
| Palbociclib | 571190-30-2 | 447.53 g/mol | In-house | Form-B Available, Form-A (under Process) | View Product |
| Pemetrexed Disodium | 357166-30-4 | 516.41 | USP / EP | Available | View Product |
| Phenylephrine Hydrochloride | 61-76-7 | 203.67 | USP / EP | Available | View Product |
| Pirfenidone | 53179-13-8 | 185.2 | API (EP/USP) | Available | View Product |
| Pomalidomide | 19171-19-8 | 273.24 | In-house | Available | View Product |
| Prucalopride Succinate | 179474-85-2 | 485.96 | In-house | Availabule | View Product |
| Ruxolitinib Hydrochloride | 1912373-07-9 | 342.83 | In-house | NA | View Product |
| Ruxolitinib Phosphate | 1092939-17-7 | 404.36 | NA | NA | View Product |
| Sunitinib Malate | 341031-54-7 | 532.56 | In-House | Available | View Product |
| Temozolomide | 85622-93-1 | 194.15 | API (USP/EP) | Available | View Product |
| Terifluonamide | 163451-81-8 | 270.2 | API (EP/USP) | Available | View Product |
| Thalidomide | 50-35-1 | 258.2 | USP/ In-House | Available | View Product |
| Topotecan Hydrochloride | 119413-54-6 | 457.9 g/mol | In-house | NA | View Product |
| Tranexamic Acid EP USP IP | 1197-18-8 | 157.2 | EP/USP/IP | Available | View Product |
| Upadacitinib | 1310726-60-3 | 380.37 | NA | NA | View Product |
| Ursodeoxycholic Acid | 128-13-2 | 392.6 | USP & EP | Available | View Product |
| Varenicline Tartrate | 375815-87-5 | 361.35 | In-House | Available | View Product |
| Zanubrutinib | 1691249-45-2 | 471.55 | API (EP/USP) | NA | View Product |
| Zoledronic Acid | 165800-06-6 | 290.1 | USP/ Ph.Eur./IH | Available | View Product |
Disclaimer
The content on this website is for general informational purposes only. While we strive for accuracy, Shilpa Pharma makes no warranties regarding the completeness, reliability, or suitability of the information. For detailed product specifications, regulatory documentation, or inquiries, please contact us directly.
Global Leaders in API Manufacturing: Oncology & Non-Oncology
Choosing Shilpa Pharma means choosing reliability, quality, and innovation. We deliver not just products, but long-term value that strengthens your business at every step.
Globally Compliant Manufacturing
Produced in cGMP-compliant facilities with approvals from USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, and KFDA.
Integrated Process Expertise
Advanced knowledge in process development, IP, and formulation ensures scalable, safe, and efficient API synthesis.
High Purity & Safety
Sensitive analytical methods control impurities and genotoxic compounds, guaranteeing high-quality APIs.
Customized Particle Size & Solid-State Forms
APIs are designed with optimized crystal morphology and particle size distribution to support successful formulation development.
Global Supply & Reliability
Consistent and timely API supply for regulated markets worldwide.
Formulation-Ready Design
APIs manufactured considering downstream formulation requirements, enhancing the probability of successful drug development.
Shilpa Pharma’s Portfolio of Anti-cancer APIs
Shilpa Pharma manufactures its Anti-Cancer APIs at cGMP-compliant facilities in India, accredited by major international regulatory authorities including USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, and KFDA. Our state-of-the-art manufacturing blocks and integrated processes ensure that each API is produced with the highest quality standards, suitable for global markets.
Our team of experts leverages deep knowledge in process development, intellectual property, and formulation to design efficient, scalable, and safe synthesis routes for oncology APIs. We employ rigorous analytical methods to control impurities, optimize solid-state forms, and meet customized particle size distribution requirements. This meticulous approach ensures a high probability of successful formulation development, enabling pharmaceutical companies worldwide to access safe, effective, and reliable anti-cancer therapies.
Shilpa Pharma: Leading APIManufacturing Company in India
Shilpa Pharma is a trusted API manufacturing company in India, specializing in both Oncology API manufacturing and Non-Oncology API solutions. As one of the top API manufacturers in India, we supply high-quality Active Pharmaceutical Ingredients (APIs) to pharmaceutical companies across India and worldwide.
Our expertise spans high-potent API (HPAPI) manufacturing, API intermediates, and comprehensive formulation-ready APIs. As a leading oncology API supplier in India, we combine advanced process development, stringent quality control, and global regulatory compliance to deliver APIs that meet international standards.
We are recognized among the most reliable API suppliers in India and pharmaceutical API suppliers, offering timely delivery, robust documentation, and support for regulated markets. Whether you’re looking for API drug manufacturers in India, oncology API manufacturers, or active pharmaceutical ingredients manufacturers, Shilpa Pharma stands out as a global partner with proven expertise and a commitment to excellence.
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Questions & Answers
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Everything You Need to Know About API Manufacturing in India at Shilpa Pharma
What makes Shilpa Pharma a trusted API manufacturing company in India?
Shilpa Pharma is recognized among the leading API manufacturers in India, offering high-quality active pharmaceutical ingredients (APIs), advanced HPAPI manufacturing, and global regulatory compliance for clients worldwide.
Do you supply Oncology APIs?
Yes, we are a top oncology API supplier in India, providing safe, effective, and formulation-ready oncology APIs for pharmaceutical companies across multiple therapeutic areas.
Can you manufacture high-potent APIs (HPAPI)?
Absolutely. Shilpa Pharma specializes in high-potent API (HPAPI) manufacturing, ensuring strict safety protocols, contamination control, and regulatory compliance.
Are you a reliable API supplier in India?
Yes, we are among the most trusted API suppliers in India and pharmaceutical API suppliers, delivering high-quality APIs with timely shipments and full regulatory documentation.
Do you produce API intermediates?
Yes, we are leading API intermediate manufacturers in India, offering intermediates and raw materials that support downstream formulation and drug development.
Can you support global regulatory markets?
Shilpa Pharma, one of the leading API manufacturers in India, provides APIs with comprehensive documentation for regulated markets worldwide, including USFDA, EU GMP, PMDA, and other international approvals.
What types of APIs do you manufacture?
We manufacture oncology APIs, non-oncology APIs, HPAPIs, and other active pharmaceutical ingredients, catering to diverse pharmaceutical segments.
Why choose Shilpa Pharma as your API drug manufacturer in India?
Shilpa Pharma combines advanced manufacturing, strict quality control, and global regulatory expertise, making us a preferred API drug manufacturer in India for both domestic and international clients.
Do you supply oncology APIs to international markets?
Yes, as a trusted oncology API supplier in India, we deliver APIs to clients across the United States, Canada, Europe, and other regulated markets, ensuring compliance with international standards.
What types of oncology APIs do you manufacture?
We manufacture a wide range of oncology APIs, including high-potent APIs (HPAPIs), intermediates, and other active pharmaceutical ingredients used in anti-cancer therapies.
Are your oncology APIs manufactured under regulated conditions?
Absolutely. Our oncology APIs are produced in cGMP-compliant facilities with approvals from USFDA, EU GMP, PMDA, ANVISA, TGA, COFEPRIS, and KFDA, ensuring safety, quality, and regulatory compliance.
Can you customize oncology API production?
Yes, we provide customized solutions in oncology API manufacturing in India, including process optimization, particle size control, and formulation-ready APIs tailored to client requirements.
Why choose Shilpa Pharma for oncology API manufacturing?
Shilpa Pharma combines advanced R&D, robust quality control, and global regulatory expertise, making us a preferred oncology API manufacturer in India for both domestic and international pharmaceutical companies.
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Learn About Active Pharmaceutical Ingredients (APIs)
Oncology API Manufacturers in India – Shilpa API manufacturing
India has become a global hub for Oncology/Non-Oncology API manufacturers, offering reliable, high-quality, and affordable solutions for the pharmaceutical industry. Among them, Shilpa API manufacturing stands out for its expertise in both oncology and non-oncology therapeutic categories, backed by advanced technology and strict compliance with international quality standards.As one of the leading Oncology API manufacturers in India, Shilpa pharma has a strong portfolio of high-potency molecules that are crucial for cancer care. The company specializes in high potent API (HPAPI) manufacturing, ensuring stringent containment and safety measures throughout the production process. This allows global pharmaceutical companies to source APIs that meet regulatory requirements across regulated and semi-regulated markets.What is Oncology API?
Oncology API refers to the Active Pharmaceutical Ingredient (API) that is used in the development of medicines for the treatment of cancer. APIs are the key components in any drug that produce the intended therapeutic effect. In the case of oncology, these APIs are specifically designed to target and fight cancer cells.High Potent API (HPAPI) Manufacturing at Shilpa
HPAPIs (High Potent Active Pharmaceutical Ingredients) are compounds that are effective at extremely low doses and are commonly used in cancer and hormone therapies. Manufacturing these substances requires specialized containment systems, advanced process controls, and highly skilled personnel.Shilpa is among the few hpapi manufacturers in India with the infrastructure and regulatory approvals to produce high potent APIs (HPAPI) safely and at scale. This includes the ability to handle cytotoxic and cytostatic compounds that are essential for advanced oncology treatments.Global Regulatory Approvals and Compliance
As a globally recognized API supplier in India, Shilpa’s manufacturing facilities meet the highest international quality standards. The company holds approvals and certifications from several major regulatory bodies, ensuring consistent product quality and regulatory compliance.Our facilities are:- USFDA Approved (United States Food & Drug Administration)
- EU GMP Certified (European Union Good Manufacturing Practice)
- ANVISA Approved (Brazilian Health Regulatory Agency)
- COFEPRIS Approved (Mexico)
- TGA Certified (Australia)
- PMDA Approved (Japan)
- KFDA Certified (South Korea)
Broad API Capabilities Beyond Oncology
In addition to its leadership in oncology, Shilpa is also a peptide API manufacturer in India, offering a diversified API portfolio. The company is involved in the production of multiple API intermediates, supporting drug development across various therapeutic areas.Whether you’re looking for API drug manufacturers in India, pharmaceutical API suppliers, or API intermediate manufacturers, Shilpa provides a comprehensive and reliable solution tailored to your project needs.Why Choose Shilpa API Manufacturing?
- Proven expertise in oncology and high potent API manufacturing
- Global regulatory approvals ensuring consistent quality
- Advanced containment and safety infrastructure
- Trusted API supplier for regulated markets
- Strong portfolio of active pharmaceutical ingredients (APIs) and intermediate
