oncology api manufacturers in india
| 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.
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