oncology api manufacturers in india
Leading API Manufacturers in India
At Shilpa Pharma, we are the trusted 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), 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. Partner with Shilpa Pharma — the brand global pharma trusts to manufacture with integrity, quality, and world-class performance.
Our Range of Oncology and Non-oncology API Product List
| API (Active Pharmaceutical Ingredients) | ||||||||||
|
S. No.
|
Oncology/Non-Oncology API
|
DMF Status | ||||||||
| Tech Pack | Open Part |
USDMF | EDMF | Health Canada |
PMDA | EDQM | KFDA | DMF Number | ||
| 1 | Ambroxol Hydrochloride | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | CEP-2004-201-Rev 06 | ||
| 2 | Abacavir sulphate | ✔ | Tech. Pack available | |||||||
| 3 | Abiraterone Acetate | ✔ | Tech. Pack available | |||||||
| 4 | Acebrophylline | ✔ | ✔ | ✔ | Tech. Pack available | |||||
| 5 | Anastrozole | ✔ | ✔ | ✔ | ✔ | USDMF# 29654 | ||||
| 6 | Axitinib | ✔ | ✔ | ✔ | USDMF# 30104 | |||||
| 7 | Azacitidine | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF#27487 | |
| 8 | Acalabrutinib | ✔ | Tech. Pack available/scale up | |||||||
| 9 | Afatinib Dimaleate | ✔ | Tech. Pack available/scale up | |||||||
| 10 | Allyl Ispropyl Acetyl Urea | ✔ | Tech. Pack available/scale up | |||||||
| 11 | Apalutamide | ✔ | Tech. Pack available/scale up | |||||||
| 12 | Bendamustine HCL Monohydrate | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 25222 | ||
| 13 | Bicalutamide | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 24690 | |||
| 14 | Bortezomib | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 24944, MF 036821 | ||
| 15 | Busulphan | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R1-CEP 2011-339-Rev 00, USDMF# 25491 | |
| 16 | Cabazitaxel Amorphous | ✔ | ✔ | ✔ | USDMF # 033087 | |||||
| 17 | Capecitabine | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R0-CEP 2014-332-Rev 01, USDMF# 24689 | |
| 18 | Carmustine | ✔ | Tech. Pack available | |||||||
| 19 | Citicholine | ✔ | Tech. Pack available | |||||||
| 20 | Clofarabine | ✔ | ✔ | ✔ | USDMF# 29806 | |||||
| 21 | Cyclophosphamide | ✔ | ✔ | ✔ | ✔ | USDMF# 034066, R0-CEP-2020-083-Rev-02 | ||||
| 22 | Dasatinib | ✔ | ✔ | Tech. Pack available | ||||||
| 23 | Decitabine | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 27488 | |||
| 24 | Dimethyl Fumarate | ✔ | ✔ | ✔ | USDMF #029655 | |||||
| 25 | Desmopressin | ✔ | ✔ | ✔ | CEP 2024-028 - Rve 00 | |||||
| 26 | Docetaxel (Anhydrous & Tri hydrate) | ✔ | Tech. Pack available/scale up | |||||||
| 27 | Doultegravir | ✔ | Tech. Pack available/scale up | |||||||
| 28 | Elthrombopag olamine | ✔ | ✔ | ✔ | USDMF #039754 | |||||
| 29 | Enzalutamide | ✔ | ✔ | ✔ | USDMF# 30260 | |||||
| 30 | Erlotinib HCL | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 29124 | |||
| 31 | Exatecan Mesylate | ✔ | Tech. Pack available/scale up | |||||||
| 32 | Fingolimod Hydrochloride | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF#28162 : R0-CEP-2019-145-Rev-01 | ||
| 33 | Gemcitabine HCl | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R1-CEP-2006-222-Rev 01, USDMF # 24136 | |
| 34 | Gemcitabine HCl (Process-2) | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF #031892, CEP-2017-187-Rev 02 | ||
| 35 | Glycopyrronium bromide | ✔ | ✔ | R0-CEP-2021-268-Rev 00 | ||||||
| 36 | Ibrutinib | ✔ | ✔ | ✔ | USDMF # 032122 | |||||
| 37 | Imatinib Mesylate | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R0-CEP-2016-121-Rev 01, USDMF# 28349 | ||
| 38 | Irinotecan HCl Trihydrate | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
USDMF# 23562, CEP : R1-CEP-2017-147-Rev 00
|
||
| 39 | Irinotecan HCl Trihydrate (Prpcess-2) | ✔ | ✔ | ✔ | ✔ | R0-CEP-2019-156-Rev 02 | ||||
| 40 | Lenalidomide | ✔ | ✔ | ✔ | USDMF # 033084 | |||||
| 41 | Lenvatinib Mesylate | ✔ | ✔ | ✔ | USDMF # 033083 | |||||
| 42 | Letrozole | ✔ | ✔ | ✔ | ✔ | ✔ | R0-CEP 2013-321-Rev 00, USDMF # 27489 | |||
| 43 | Liraglutide | ✔ | Tech. Pack available/scale up | |||||||
| 44 | Melphalan HCL | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 28930 | |||
| 45 | Methotrexate | ✔ | ✔ | CEP 2024-465 (Under review) | ||||||
| 46 | Montelukast Sodium | ✔ | ✔ | CEP 2024-125 (Under review) | ||||||
| 47 | Methotrexate Sodium | ✔ | Tech. Pack available & USDMF | |||||||
| 48 | Mycophenolate mofetil | ✔ | Tech. Pack available | |||||||
| 49 | Mycophenolate sodium | ✔ | Tech. Pack available | |||||||
| 50 | Nifedipine | ✔ | ✔ | ✔ | CEP 2022-475 - Rev 00 : USDMF#036235 | |||||
| 51 | Nilotinib | ✔ | ✔ | USDMF# 036289 | ||||||
| 52 | Nintedanib | ✔ | Tech. Pack available | |||||||
| 53 | Oxaliplatin | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R1-CEP 2006-201-Rev 01, USDMF # 23563 | ||
| 54 | Octreotide | ✔ | ✔ | CEP 2024-102 - Rev 00 | ||||||
| 55 | Oxacarbazipine | ✔ | ✔ | CEP 2022-458 (Under review) | ||||||
| 56 | Olaparib | ✔ | Tech. Pack available/scale up | |||||||
| 57 | Palbocicilib | ✔ | Tech. Pack available | |||||||
| 58 | Pazopanib | ✔ | Tech. Pack available | |||||||
| 59 | Pemetrexed DiPotassium Nonahydrate | ✔ | ✔ | ✔ | ✔ | USDMF# 29652 : R0-CEP 2022-087-Rev 00 | ||||
| 60 | Pemetrexed Disodium Hemipentahydrate | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF# 25102 | ||
| 61 | Phenylephrine Hydrochloride | ✔ | ✔ | ✔ | USDMF# 36236 : CEP 2024-377 | |||||
| 62 | Pirfenidone | ✔ | ✔ | ✔ | ✔ | R0-CEP 2016-242-Rev 00, USDMF #030952 | ||||
| 63 | Pomalidomide | ✔ | ✔ | ✔ | USDMF # 032309 | |||||
| 64 | Praziquintol | ✔ | ✔ | ✔ |
WHO Market (APIMF-390) :R0-CEP-2019-207-Rev-01
|
|||||
| 65 | Prucalopride Succinate | ✔ | ✔ | ✔ | ✔ | USDMF #035038 | ||||
| 66 | Paclitaxel | ✔ | Tech. Pack available/scale up | |||||||
| 67 | Pazopanib | ✔ | Tech. Pack available/scale up | |||||||
| 68 | Ruxolitinib Phospate | ✔ | Tech. Pack available/scale up | |||||||
| 69 | Sodium Cholesteryl sulfate | ✔ | Tech. Pack available | |||||||
| 70 | Sorafenib Tosylate | ✔ | ✔ | ✔ | CEP 2022-056-Rev 00 | |||||
| 71 | Sunitinib Malate | ✔ | ✔ | ✔ | ✔ | USDMF # 033085 | ||||
| 72 | Sertraline hydrochloride | ✔ | Tech. Pack available/scale up | |||||||
| 73 | Sodium cholesteryl sulfate (SCS) | ✔ | Tech. Pack available/scale up | |||||||
| 74 | Semaglutide | ✔ | Tech. Pack available/scale up | |||||||
| 75 | Temozolomide | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | R0-CEP 2016-277-Rev 01, USDMF# 23479 |
| 76 | Tenofovir alfanamide | ✔ | ✔ | ✔ | USDMF #033850 | |||||
| 77 | Tenofovir disproxyl fumarate API | ✔ | ✔ | WHO Market (APIMF-391) | ||||||
| 78 | Teriflunomide | ✔ | ✔ | ✔ | USDMF #032172 : CEP 2023-313 - Rev 00 | |||||
| 79 | Thalidomide | ✔ | ✔ | ✔ | ✔ | USDMF # 033088 | ||||
| 80 | Tranexamic Acid | ✔ | ✔ | ✔ | ✔ | R0-CEP 2018-048-Rev 00, USDMF #033086 | ||||
| 81 | Tofacitinib | ✔ | Tech. Pack available | |||||||
| 82 | Topotecan HCL | ✔ | Tech. Pack available | |||||||
| 83 | Tofacitinib Citrate | ✔ | Tech. Pack available/scale up | |||||||
| 84 | Teriparatide | ✔ | Tech. Pack available/scale up | |||||||
| 85 | Tirzepatide | ✔ | Tech. Pack available/scale up | |||||||
| 86 | Ursodeoxycholic acid | ✔ | ✔ | CEP 2022-275 - Rev 00 | ||||||
| 87 | Varenicline tartrate | ✔ | ✔ | ✔ | USDMF #035037 | |||||
| 88 | Valacyclovir | ✔ | Tech. Pack available/scale up | |||||||
| 89 | Vismodegib | ✔ | Tech. Pack available/scale up | |||||||
| 90 | Zoledronic acid | ✔ | ✔ | ✔ | ✔ | ✔ | USDMF #025905 : CEP-2021-269-Rev 01 | |||
| S. No. | Oncology/Non-Oncology API | DMF Status | DMF Number | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Tech Pack | Open Part | USDMF | EDMF | Health Canada | PMDA | EDQM | KFDA | |||
| 1 | Ambroxol Hydrochloride | ✔ | ✔ | - | ✔ | - | ✔ | ✔ | ✔ | CEP-2004-201-Rev 06 |
| 2 | Abacavir sulphate | ✔ | - | - | - | - | - | - | - | Tech. Pack available |
| 3 | Abiraterone Acetate | ✔ | - | - | - | - | - | - | - | Tech. Pack available |
| 4 | Acebrophylline | ✔ | ✔ | - | - | - | - | - | ✔ | Tech. Pack available |
| 5 | Anastrozole | ✔ | ✔ | ✔ | - | - | ✔ | - | - | USDMF# 29654 |
| 6 | Axitinib | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 30104 |
| 7 | Azacitidine | ✔ | ✔ | ✔ | ✔ | ✔ | - | ✔ | ✔ | USDMF# 27487 |
| 8 | Acalabrutinib | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 9 | Afatinib Dimalate | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 10 | Allyl Isopropyl Acetyl Urea | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 11 | Apalutamide | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 12 | Bendamustine HCL Monohydrate | ✔ | ✔ | ✔ | ✔ | ✔ | - | - | ✔ | USDMF# 25222 |
| 13 | Bicalutamide | ✔ | ✔ | ✔ | ✔ | - | ✔ | - | - | USDMF# 24690 |
| 14 | Bortezomib | ✔ | ✔ | ✔ | ✔ | ✔ | - | - | ✔ | USDMF# 24944, MF 036821 |
| 15 | Busulphan | ✔ | ✔ | ✔ | - | ✔ | ✔ | ✔ | ✔ | R1-CEP 2011-339-Rev 00, USDMF# 25491 |
| 16 | Cabazitaxel Amorphous | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 033087 |
| 17 | Capecitabine | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ | - | RO-CEP 2014-332-Rev 01, USDMF# 24689 |
| 18 | Carmustine | ✔ | - | - | - | - | - | - | - | Tech. Pack available |
| 19 | Citicholine | ✔ | - | - | - | - | - | - | - | Tech. Pack available |
| 20 | Clofarabine | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 29806 |
| 21 | Cyclophosphamide | ✔ | ✔ | ✔ | - | - | - | ✔ | - | USDMF# 034066, RO-CEP-2020-083-Rev-02 |
| 22 | Dasatinib | ✔ | ✔ | - | - | - | - | - | - | Tech. Pack available |
| 23 | Decitabine | ✔ | ✔ | ✔ | - | ✔ | - | - | ✔ | USDMF# 27485 |
| 24 | Dimethyl Fumarate | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 402955 |
| 25 | Desmopressin | ✔ | ✔ | - | - | - | - | ✔ | - | CEP 2024-028 - Rev 00 |
| 26 | Docetaxel (Anhydrous & Tri hydrate) | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 27 | Dolutegravir | ✔ | - | - | - | - | - | - | - | - |
| 28 | Eltrombopag olamine | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 403754 |
| 29 | Enzalutamide | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 30206 |
| 30 | Erlotinib HCL | ✔ | ✔ | ✔ | ✔ | - | - | - | ✔ | USDMF# 29124 |
| 31 | Exatecan Mesylate | ✔ | - | - | - | - | - | - | - | Tech. Pack available/scale up |
| 32 | Fingolimod Hydrochloride | ✔ | ✔ | ✔ | ✔ | ✔ | - | ✔ | - | USDMF# 28162 : RO-CEP-2019-145-Rev-01 |
| 33 | Gemcitabine HCL | ✔ | ✔ | ✔ | - | ✔ | ✔ | ✔ | ✔ | R1-CEP-2005-222-Rev 01, USDMF# 24136 |
| 34 | Gemcitabine HCL (Process-2) | ✔ | ✔ | ✔ | ✔ | ✔ | - | ✔ | - | USDMF# 031892, CEP-2017-187-Rev 02 |
| 35 | Glycopyrronium bromide | ✔ | - | - | - | - | - | ✔ | - | RO-CEP-2021-628-Rev 00 |
| 36 | Ibrutinib | ✔ | ✔ | ✔ | - | - | - | - | - | USDMF# 032122 |
| 37 | Imatinib Mesylate | ✔ | ✔ | ✔ | ✔ | - | - | ✔ | ✔ | RO-CEP-2016-121-Rev 01, USDMF# 28349 |
To request a quote or learn more about our Oncology API products and services, please contact us.
Our Expertise at a Glance
Leading the Way in Pharma Innovation
1987
Established
100+
R&D workforce
1500+
Team size
3
Manufacturing site
100+
Audits
500+
Customers
100+
Projects
Shilpa Pharma’s Portfolio of API Pharmaceutical Products
We offer a comprehensive portfolio of high-quality APIs across major therapeutic areas, including:
- Oncology – Highly potent APIs produced in state-of-the-art containment facilities.
- Cardiovascular – APIs supporting critical treatments for heart and blood pressure disorders.
- Central Nervous System (CNS) – APIs for psychiatric, neurological, and pain management therapies.
- Antiviral & Antiretroviral – APIs essential for global infectious disease management.
- Antidiabetic – APIs ensuring effective control of metabolic and diabetic conditions.
- Anti-inflammatory & Analgesic – APIs designed for inflammation control and pain relief.
At Shilpa Pharma, quality and regulatory excellence form the core of our operations. Our manufacturing facilities are cGMP-compliant and approved or inspected by major international regulatory authorities
Serving Clients Across The Globe
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)
These certifications position Shilpa Pharma as a trusted partner for both regulated and semi-regulated markets.
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