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Details
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Specifications
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CAS Number
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191732-72-6
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Molecular Formula
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C13H13N3O3
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Molecular Weight
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259.26 g/mol.
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Synonyms
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3-(4-Amino-1-oxo-1,3-dihydro-2H-dihydro-2H-isoindol-2-yl) piperidin-2,6-dione
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Chemical Name
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(RS)-3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperdine-2,6-dione
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Common name
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Lenalidomide
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Therapeutic use
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Antimetabolite chemotherapy, Chemotherapy for pancreatic lung cancer, breast cancer and bladder cancer.
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Background
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Lenalidomide is a medication used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS) in adults.
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Grade
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In-house
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Polymorph
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Form A
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GTI
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Risk assessment report available
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Nitrosamines
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Risk assessment report available
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DMF Availability
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USDMF# 33084, ASMF# 2025-073
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Manufacturing batch size
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15.0 Kg
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Production capacity
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Annual capacity is 1.5 - 2.0 tonnes
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Stability data
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Available
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Lenalidomide is an immunomodulatory drug (IMiD) and an oral small-molecule active pharmaceutical ingredient (API) used mainly in the treatment of blood cancers. A more advanced analogue of thalidomide, it combines immune-modulating, anti-angiogenic, and anti-cancer actions. The reference brand is Revlimid, and Lenalidomide remains one of the highest-value oncology and haematology molecules in the world, now widely available as a generic API.
Shilpa Pharma is a trusted Lenalidomide API manufacturer and supplier in India, producing this molecule at cGMP-compliant, globally audited facilities. Backed by decades of oncology API expertise, Shilpa Pharma supports generic drug developers and innovator companies with high-purity Lenalidomide API and complete regulatory documentation.
Key specifications
As one of India’s leading oncology API manufacturers, Shilpa Pharma combines strong process chemistry, strict quality control, and world-class API manufacturing in India to deliver Lenalidomide that meets the most demanding global standards.
Lenalidomide API is used to manufacture prescription medicines for blood cancers and related disorders. Approved uses of Lenalidomide-based drugs include multiple myeloma (including maintenance therapy), myelodysplastic syndromes (MDS) with a deletion 5q abnormality, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.
The molecule belongs to the immunomodulatory drug (IMiD) class. In simple terms, it binds a protein called cereblon inside cells, which triggers the breakdown of specific cancer-driving proteins. This produces three combined effects: it slows cancer cell growth, reduces the blood supply that tumours need, and strengthens the body’s own immune response against cancer cells.
For formulation, Lenalidomide is developed as an oral solid dosage form, most commonly capsules in strengths ranging from 2.5 mg to 25 mg. Shilpa Pharma supplies Lenalidomide API with controlled particle size and consistent solid-state quality to support stable, reproducible formulation development.
Shilpa Pharma supplies Lenalidomide API and related API intermediates to regulated markets (US, EU, Japan, Australia) and emerging markets. With integrated CDMO services, the company can also support custom development, scale-up, and long-term commercial supply for oncology programs.
Lenalidomide is a potent and highly regulated molecule, so it must be handled with strict safety controls at every stage of manufacturing. Shilpa Pharma produces Lenalidomide API under controlled containment, using trained personnel and protective systems that safeguard both product quality and operator safety. These are the same high standards applied by dedicated HPAPI manufacturers in India.
On product safety, Shilpa Pharma places strong focus on impurity control. A nitrosamine and genotoxic impurity (GTI) risk assessment report is available for Lenalidomide, and sensitive analytical methods keep impurities within safe, regulator-approved limits. Every batch is supported by complete quality and stability documentation.
From a clinical reference point, Lenalidomide medicines carry important prescribing precautions, including boxed warnings for embryo-foetal toxicity (a high risk of severe birth defects), blood-related toxicity, and blood clots. Because of the birth-defect risk, finished products are distributed under controlled risk-management programs. This information is shared only as scientific reference for drug developers and is not medical advice.
Shilpa Pharma supplies Lenalidomide API strictly to licensed pharmaceutical manufacturers, biotech firms, and authorised partners, with full regulatory support for safe use in global drug products.
Lenalidomide API pricing is shared on request. Because API cost depends on order volume, delivery timelines, target market, and regulatory requirements, Shilpa Pharma provides a customised quotation for every enquiry rather than a fixed list price.
To receive current Lenalidomide API pricing, availability, and documentation (including DMF and technical data), please contact the Shilpa Pharma team. Minimum order quantities apply, and Shilpa Pharma partners exclusively with pharmaceutical manufacturers, biotech companies, and authorised trading firms.
Email: info@shilpapharma.com | Request a Quote
Choosing the right Lenalidomide API supplier means choosing quality, compliance, and reliability. Here is why global pharmaceutical companies trust Shilpa Pharma:
With decades of proven expertise and world-class API manufacturing in India, Shilpa Pharma is the partner of choice for companies developing safe, effective cancer therapies. For a single-source Lenalidomide API supplier or a long-term manufacturing partner, Shilpa Pharma delivers integrity, quality, and global performance.
Partner with a trusted Lenalidomide manufacturer in India. Contact Shilpa Pharma today.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
