World-Class HPAPI Manufacturing
High Potent API Manufacturing in India
HPAPI Manufacturers and Suppliers in India
Shilpa Pharma is one of India’s most trusted and established High-Potent API (HPAPI) manufacturers, recognized for its state-of-the-art isolator technology and world-class containment infrastructure. As the first company in India to implement a fully integrated isolator-based HPAPI manufacturing ecosystem, we deliver comprehensive, end-to-end solutions for both oncology and non-oncology high-potent compounds.
Our advanced high-containment facilities are purpose-built to safely manage OEL bands 1 through 5, supporting the entire lifecycle of HPAPI projects—from early-stage development and clinical supply to large-scale commercial manufacturing. With nine dedicated cytotoxic manufacturing blocks and a standalone analytical laboratory, Shilpa Pharma ensures stringent quality control, operational excellence, and regulatory compliance at every stage.
Shilpa Pharma operates in accordance with global regulatory standards and holds multiple international accreditations, including USFDA approval, EU GMP certification, CDSCO approval, and compliance with other leading global health authorities. These accreditations reinforce our commitment to quality, safety, and regulatory excellence across global markets.
Whether your requirement is process development, scale-up, or full commercial production, Shilpa Pharma delivers precision-driven, safe, and efficient HPAPI manufacturing and development making us a preferred global partner for pharmaceutical innovators worldwide.
Complete Range of HPAPI
| Product Name | CAS Number | Grade | DMF Status | Production Capacity | Nitrosamines / GTI | View Product |
|---|---|---|---|---|---|---|
| Abiraterone Acetate | 154229-18-2 | USP | USDMF# 041901 | Annual capacity is 20 - 25 tonnes | Risk assessment report available | View Product |
| Afatinib Dimaleate | 850140-73-7 | In-house | - | - | Risk assessment report available | View Product |
| Ambroxol Hydrochloride | 23828-92-4 | EP | CEP 2004 - 201 - Rev 06 | Annual capacity is 280 – 300 tonnes. | - | View Product |
| Amifampridine phosphate | 446254-47-3 | In house | ASMF# 4755 | 80-100 kg per annum | Risk assessment report available | View Product |
| Axitinib | 319460-85-0 | USP | USDMF# 30104, EMEA / ASMF 01483 | Annual capacity is 50 – 60 Kg | Risk assessment report available | View Product |
| Azacitidine | 320-67-2 | USP | USDMF# 27487, ASMF# EU / ASMF / 00265 | Annual capacity is 3.0 – 4.0 tonnes. | Risk assessment report available | View Product |
| Bendamustine Hydrochloride | 3543-75-7 | USP & EP | USDMF# 25222, ASMF # 551039 | 80-100 kg | Risk assessment report available | View Product |
| Bicalutamide | 90357-06-05 | EP and USP | USDMF# 24690, ASMF # 551928 | Annual capacity 6.0 – 7.0 tonnes | Risk assessment report available | View Product |
| Bortezomib | 179324-69-7 | In-house | USDMF# 24944, ASMF # EMEA / ASMF / 01222 | Annual capacity 40 – 50 kg | Risk assessment report available | View Product |
| Busulfan | 55-98-1 | EP and USP | USDMF# 25491, R1 - CEP 2011 - 339 - REV 02 | Annual capacity 500 – 600 kg | Risk assessment report available | View Product |
| Cabazitaxel | 183133-96-2 | In house | USDMF# 33087, ASMF # EU / ASMF / 00475 | Annual capacity is 12-15 kg | Risk assessment report available | View Product |
| Capecitabine | 154361-50-9 | EP and USP | USDMF# 24689, CEP 2014-332 - REV 03 | Annual capacity 48 – 50 tonnes | Risk assessment report available | View Product |
| Citicoline sodium | 33818-15-4 | USP & EP | USDMF available. | Annual capacity is 15 – 20 tonnes | Risk assessment report available | View Product |
| Clofarabine | 123318-82-1 | In-house | USDMF# 29806, ASMF # 552005 | Annual capacity is 8.0 – 10.0 kg | Risk assessment report available | View Product |
| Cyclophosphamide monohydrate | 6055-19-2 | EP & USP | USDMF# 34066, R0-CEP 2020 - 083 - Rev 02 | Annual capacity is 2.5 – 3.0 tonnes | Risk assessment report available | View Product |
| Dasatinib | 302962-49-8 | In-house | USDMF# 041834 | Annual capacity is 1.5 – 2.0 tonnes | Risk assessment report available | View Product |
| Decitabine | 2353-33-5 | EP and USP | USDMF# 27488, EU/ASMF # 4163 | Annual capacity 40-50 Kg | Risk assessment report available | View Product |
| Dimethyl fumarate | 624-49-7 | USP | USDMF# 29655 | Annual capacity 30 – 40 tonnes | Risk assessment report available | View Product |
| Docetaxel Anhydrous | 114977-28-5 | EP | - | - | Risk assessment report available | View Product |
| Docetaxel Trihydrate | 148408-66-6 | EP | - | - | Risk assessment report available | View Product |
| Edoxaban tosylate monohydrate | 1229194-11-9 | In-house | - | - | Risk assessment report available | View Product |
| Eltrombopag Olamine | 496775-62-3 | In-house | USDMF# 039754 | Annual capacity 600 – 700 Kg | Risk assessment report available | View Product |
| Enzalutamide | 915087-33-1 | USP | USDMF# 30260 | Annual capacity is 1.0 - 1.5 tonnes | Risk assessment report available | View Product |
| Erlotinib Hydrochloride | 183321-74-6 | In-house | USDMF# 29124, ASMF # 4163 | Annual capacity is 15 – 20 tonnes | Risk assessment report available | View Product |
| Fingolimod Hydrochloride | 162359-56-0 | EP and USP | USDMF# 28162, R0 - CEP 2019 - 145 - Rev 01 | Annual capacity 60 – 70 kg | Risk assessment report available | View Product |
| Gemcitabine Hydrochloride | 122111-03-9 | EP & USP | USDMF# 24136, CEP 2006-222-Rev 02 | Annual capacity is 3 – 5 tonnes | Risk assessment report available | View Product |
| Glycopyrronium bromide | 51186-83-5 | EP and USP | DMF Available, R0 - CEP 2021 -268 - Rev 00 | Annual capacity 40-50 Kg | Risk assessment report available | View Product |
| Ibrutinib | 936563-96-1 | In-house | USDMF# 32122 | Annual capacity is 5 – 6 tonnes | Risk assessment report available | View Product |
| Ibrutinib premix | 936563-96-1 | In-house | Available | Annual capacity is 5 – 6 tonnes | Risk assessment report available | View Product |
| Imatinib mesylate | 220127-57-1 | EP & USP | USDMF# 28349, R1 - CEP-2016 - 121 - Rev 01 | Annual capacity is 12 – 15 tonnes | Risk assessment report available | View Product |
| Irinotecan Hydrochloride Trihydrate | 136572-09-3 | EP and USP | USDMF# 23562, R1 - CEP-2017 - 147 - Rev 00 | Annual capacity 800 – 900 kg | Risk assessment report available | View Product |
| Lenalidomide | 191732-72-6 | In-house | USDMF# 33084, ASMF# 2025-073 | Annual capacity is 1.5 - 2.0 tonnes | Risk assessment report available | View Product |
| Lenvatinib Mesylate | 857890-39-2 | In-house | USDMF# 33083, ASMF # EU / ASMF / 00829 | Annual capacity is 0.8-1.0 tonnes | Risk assessment report available | View Product |
| Macitentan | 441798-33-0 | In-house | - | -- | Risk assessment report available | View Product |
| Melphalan Hydrochloride | 148-82-3 | EP & USP | USDMF# 28930, ASMF NO: 4755 | Annual capacity is 140 -160kg | Risk assessment report available | View Product |
| Methotrexate base | 59-05-2 | In-house | USDMF# 042056, CEP# 2024-465 | Annual capacity is 1.5 – 1.8 tonnes | Risk assessment report available | View Product |
| Methotrexate Disodium | 7413-34-5 | In-house | - | Annual capacity is 1.5 – 1.8 tonnes | Risk assessment report available | View Product |
| Montelukast Sodium | 151767-02-1 | EP & USP | CEP 2024-125 | Annual capacity is 3 – 4 tonnes | Risk assessment report available | View Product |
| Mycophenolate Mofetil | 128794-94-5 | EP & USP | - | Annual capacity is 20 – 24 tonnes | Risk assessment report available | View Product |
| Mycophenolate Sodium | 37415-62-6 | EP & USP | - | Annual capacity is 30 – 40 tonnes | Risk assessment report available | View Product |
| Nifedipine | 21829-25-4 | EP, USP, IP & BP | USDMF# 36235, CEP 2022 - 475- Rev 00 | Annual capacity is 60 – 70 tonnes | Risk assessment report available | View Product |
| Nilotinib | 641571-10-0 | In-house | USDMF# 36289, EU / ASMF / 00662 / 001 | Annual capacity is 4.0 - 6.0 tonnes | Risk assessment report available | View Product |
| Nilotinib hydrochloride monohydrate | 923288-90-8 | In-house | - | - | Risk assessment report available | View Product |
| Nintedanib esylate | 656247-18-6 | In-house | - | - | - | View Product |
| Olaparib | 763113-22-0 | In-house | - | Annual capacity is 3 – 4 tonnes | Risk assessment report available | View Product |
| Oxaliplatin | 61825-94-3 | EP and USP | USDMF# 23563, R1 - CEP - 2006 - 201 - Rev 02 | Annual capacity 220 – 250 kg | Risk assessment report available | View Product |
| Oxcarbazepine | 28721-07-05 | EP & USP | DMF Available, CEP 2022 - 458-Rev 00 | Annual capacity 220 – 250 kg | Risk assessment report available | View Product |
| Paclitaxel | 33069-62-4 | EP | - | - | Risk assessment report available | View Product |
| Palbociclib | 571190-30-2 | In-house | USDMF# 042794 | Annual capacity is 1.2 - 1.5 tonnes | Risk assessment report available | View Product |
| Pazopanib Hydrochloride Monohydrate | 635702-64-6 | In-house | -- | -- | Risk assessment report available | View Product |
| Pemetrexed disodium | 357166-30-4 | EP & USP | USDMF# 25102, R0 - CEP -2022 - 087 - Rev 00 | Annual capacity 0.8 to 1.0 tonnes | Risk assessment report available | View Product |
| Phenylephrine Hydrochloride | 67-76-7 | EP, USP, IP & BP | USDMF# 36236, CEP 2024 - 377 | Annual capacity is 5.0 – 6.0 tonnes | Risk assessment report available | View Product |
| Pirfenidone | 53179-13-8 | EP & USP | USDMF# 30952, CEP 2016 - 242 - Rev 01 | Annual capacity is 20-25 tonnes | Risk assessment report available | View Product |
| Pomalidomide | 19171-19-8 | In house | USDMF# 32309, EU / ASMF / 00670 | Annual capacity 300 - 350 kg | Risk assessment report available | View Product |
| Praziquantel | 55268-74-1 | EP & USP | -- | Annual capacity* *is* *10 – 20 tonnes. | Risk assessment report available | View Product |
| Prucalopride Succinate | 179474-85-2 | EP & USP | USDMF# 35038, ASMF: EU / ASMF / 00355 | Annual capacity 200 – 250 Kg | Risk assessment report available | View Product |
| Ruxolitinib phosphate | 1092939-17-7 | EP | -- | Annual capacity is 250 - 300*Kg* | Risk assessment report available | View Product |
| Sorafenib Tosylate | 475207-59-1 | In-house | CEP 2022 - 056 - Rev 01 | Annual capacity is 1.0 - 1.2 tonnes | Risk assessment report available | View Product |
| Sunitinib Malate | 341031-54-7 | In-house | USDMF# 33085, ASMF# EU / ASMF / 00359 / 0001 | Annual capacity is 1.0 - 1.2 tonnes | Risk assessment report available | View Product |
| Temozolomide | 85622-93-1 | EP and USP | USDMF# 23479, CEP 2016 -277 - Rev 00 | Annual capacity 2.0 - 2.2 tonnes | Risk assessment report available | View Product |
| Tenofovir Alafenamide Hemifumarate | 1392275-56-7 | In-house | USDMF# 33850 | Annual capacity is 2.0 – 2.2 tonnes | Risk assessment report available | View Product |
| Terifluonamide | 163451-81-8 | EP | USDMF# 32172, CEP 2023 - 313- Rev 00 | Annual capacity is 200 - 300 Kg | Risk assessment report available | View Product |
| Thalidomide | 50-35-1 | USP | USDMF# 23479, CEP 2016 -277 - Rev 00 | Annual capacity 2.0 - 2.2 tonnes | Risk assessment report available | View Product |
| Topotecan Hydrochloride | 119413-54-6 | In-house | -- | Annual capacity is 20 – 30 Kg | Risk assessment report available | View Product |
| Tranexamic acid | 1197-18-8 | EP, USP and IP | USDMF# 33086, CEP 2018 - 048 - Rev 02 | Annual capacity 300 - 350 tonnes | Risk assessment report available | View Product |
| Ursodeoxycholic acid | 128-13-2 | USP & EP | USDMF# 042055, CEP 2022 - 275 Rev 00 | Annual capacity is 60 – 70 tonnes. | Risk assessment report available | View Product |
| Varenicline Tartrate | 375815-87-5 | In house | USDMF# 35037, ASMF # EU / ASMF / 00489 | Annual capacity 100 - 120 kg | Risk assessment report available | View Product |
| Vismodegib | 879085-55-9 | In-house | - | -- | Risk assessment report available | View Product |
| Zoledronic acid | 165800-06-6 | EP and USP | USDMF# 25905, CEP - 2021 - 269 - Rev 01 | Annual capacity 25 - 30 kg | Risk assessment report 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.
lobal Leaders in HPAPI 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
High potent APIs are developed and manufactured in cGMP-compliant facilities with regulatory approvals from USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, and KFDA, ensuring global market acceptance.
Integrated HPAPI Development Expertise
Deep expertise in HPAPI development, process chemistry, intellectual property, and formulation enables safe, scalable, and efficient HPAPI manufacturing across oncology and non-oncology programs.
High Potent API Purity & Safety
Advanced analytical techniques are employed to tightly control impurities and genotoxic compounds, ensuring consistent quality and safety in high potent API manufacturing.
Customized Particle Size & Solid-State Forms
HPAPIs are engineered with optimized crystal morphology, particle size distribution, and solid-state forms to support robust and successful formulation development.
Global Supply Reliability
As a trusted HPAPI CDMO, Shilpa Pharma ensures consistent, secure, and timely high potent API supply to regulated markets worldwide.
Formulation-Ready HPAPIs
APIs are designed with downstream formulation requirements in mind, improving process efficiency and increasing the probability of successful drug development.
Leading Highly Potent API Contract Manufacturing
Shilpa Pharma is recognised as one of the most trusted HPAPI CDMOs globally, offering end-to-end CDMO development support for high-potent molecules across oncology and specialty therapies. With India’s first and most advanced isolator-based high-containment CDMO infrastructure, we ensure absolute safety, precision, and purity throughout the development lifecycle—from preclinical to scale-up to commercial production. Our CDMO services are built around strict OEL Band 1–5 capabilities, allowing clients to confidently outsource even the most complex and sensitive HPAPI projects.
What makes Shilpa Pharma a preferred HPAPI CDMO partner worldwide is our ability to blend scientific depth, regulatory strength, and high-potency expertise under one roof. With nine dedicated cytotoxic CDMO blocks and a specialised analytical ecosystem, we consistently deliver reliable, compliant, and globally accepted HPAPI development outcomes. Companies choose us because we don’t just manufacture—we co-develop, optimise, and accelerate their high-potency pipeline with unmatched containment technology, operational excellence, and a proven record of supporting top global innovators.
Shilpa Pharma: Leading HPAPI Manufacturing Company in India
Shilpa Pharma is a trusted HPAPI manufacturer in India, specializing in both oncology and non-oncology high potent API manufacturing. As a leading name in HPAPI development and manufacturing, we deliver high-quality high potent APIs to pharmaceutical companies across India and global regulated markets.
Our expertise spans HPAPI development, HPAPI manufacturing, and HPAPI contract manufacturing, supported by advanced isolator-based containment systems and formulation-ready API design. As an experienced HPAPI CDMO, Shilpa Pharma combines robust process development, stringent quality control, and global regulatory compliance to produce safe, scalable, and compliant high potent APIs.
Recognized among the most reliable HPAPI manufacturers and suppliers in India, we ensure consistent supply, comprehensive documentation, and regulatory support for USFDA, EU, and other international markets. Whether you are seeking an HPAPI contract manufacturing partner, a specialized oncology HPAPI manufacturer, or a globally compliant HPAPI CDMO, Shilpa Pharma stands out as a trusted partner with proven expertise and a commitment to excellence.
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Everything You Need to Know About API Manufacturing in India at Shilpa Pharma
What is HPAPI manufacturing, and why is it critical for modern pharmaceuticals?
HPAPI (High Potent Active Pharmaceutical Ingredient) manufacturing involves the production of highly potent compounds that are effective at very low doses. These APIs are widely used in oncology, hormonal therapies, and targeted treatments. Due to their high potency and toxicity, HPAPI manufacturing requires specialized containment systems, advanced process controls, and strict regulatory compliance to ensure safety, quality, and consistency.
Why is India emerging as a preferred destination for HPAPI manufacturing?
India has become a global hub for HPAPI manufacturing due to its strong pharmaceutical ecosystem, cost-efficient production, skilled scientific workforce, and globally compliant infrastructure. Indian HPAPI manufacturers like Shilpa Pharma combine advanced containment technology with international regulatory approvals, making India a strategic choice for global pharmaceutical companies.
What makes Shilpa Pharma a leading HPAPI manufacturer in India?
Shilpa Pharma is a leading HPAPI manufacturer in India with advanced isolator-based containment facilities and extensive experience in oncology and non-oncology high potent APIs. As one of the first companies in India to establish a fully integrated HPAPI manufacturing system, Shilpa Pharma offers end-to-end HPAPI development, scale-up, and commercial manufacturing under global regulatory standards.
What types of HPAPIs does Shilpa Pharma manufacture?
Shilpa Pharma specializes in both oncology and non-oncology HPAPIs, including cytotoxic and highly potent compounds across multiple therapeutic areas. The company supports HPAPI development from early-stage process research to large-scale commercial production.
How does Shilpa Pharma ensure safety in high potent API manufacturing?
Safety is central to HPAPI manufacturing at Shilpa Pharma. The company operates high-containment facilities designed to handle OEL bands 1 to 5, supported by isolator technology, closed processing systems, and stringent EHS protocols. These measures ensure operator safety, environmental protection, and product integrity throughout the manufacturing process.
What regulatory standards does Shilpa Pharma follow for HPAPI manufacturing?
Shilpa Pharma’s HPAPI manufacturing facilities are cGMP-compliant and approved by major global regulatory authorities, including USFDA, EU GMP, ANVISA, COFEPRIS, TGA, PMDA, KFDA (MFDS), and CDSCO. This ensures seamless supply to regulated markets worldwide.
Does Shilpa Pharma offer HPAPI contract manufacturing and CDMO services?
Yes, Shilpa Pharma operates as a full-service HPAPI CDMO, offering HPAPI contract manufacturing, process development, scale-up, analytical support, and regulatory documentation. This integrated approach enables pharmaceutical companies to accelerate development timelines while maintaining quality and compliance.
How does Shilpa Pharma support HPAPI development and scale-up?
Shilpa Pharma provides comprehensive HPAPI development services, including route scouting, process optimization, impurity profiling, and solid-state development. These capabilities ensure smooth scale-up from laboratory to commercial manufacturing while maintaining safety, yield, and product quality.
How does Shilpa Pharma ensure high purity and quality in HPAPI manufacturing?
Advanced analytical techniques and sensitive impurity control methods are used to monitor genotoxic impurities and ensure consistent product quality. Dedicated analytical laboratories and robust quality systems support high purity standards required for high potent API manufacturing.
Why choose Shilpa Pharma as your HPAPI manufacturing partner in India?
With proven expertise in HPAPI development, advanced containment infrastructure, global regulatory approvals, and reliable supply capabilities, Shilpa Pharma is a trusted HPAPI manufacturing partner in India. The company’s commitment to safety, quality, and compliance makes it a preferred choice for pharmaceutical companies seeking a long-term HPAPI CDMO partner.
