Hikal Ltd | Bangalore, India

Hikal Ltd | Bangalore, India

cGMP Process Development, Scale-up and Manufacturing of Small Molecule APIs, NMEs and Intermediates from grams to kilograms to tones, lab to commercial launch.

About the plant

At Hikal, we partner with pharmaceutical companies worldwide to take molecules from early lead generation all the way to commercial launch. We specialize in the manufacture of small molecule APIs, New Molecular Entities and Intermediates, backed by strengths in Chiral Chemistry, Custom Synthesis, and Contract Research. Our focus is simple: deliver innovation, compliance, and scalability at every stage.

Facilties and Capabilties:

• Kilo Labs: Designed for scale up studies from R&D to production.
• Pilot Plant: Flexible cGMP compliant facility producing batches for preclinical and clinical trials.
• Launch Plant: Large scale cGMP plant equipped for advanced chemistries and commercial supply.
• Multipurpose Pilot Plant: US FDA approved site offering validation and launch quantities with PLC controlled operations
• High Potent Facility: Specialized unit for handling highly potent compounds safety at lab scale.
• Specialized Labs: Process Intensification, and Solid State Chemistry, supported by Advanced Analytics.

What We Offer:

• APIs, Advanced Intermediates, and New Molecular Entities
• Process Development and Technology Transfer
• Custom Synthesis, Contract Research and Manufacturing
• Regulatory Compliance and IP Protection

Why Choose Us:

We provide scalable production from grams to tones, operate under global regulatory approvals (USFDA, ANVISA, PMDA, EDQM), and are driven by innovation and strong R&D capabilities. Our long standing partnerships with leading pharma companies reflect our commitment to quality, reliability and confidentiality.

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Compliance

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• ECOVADIS
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• PMDA/MHLW (Japan GMP)
• COFEPRIS
• Halal Research Council
• 9001
• 14001
• 45001

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Activity

• CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, SERVICES, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Building Blocks, Loose powder, Powders manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L

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Services

• Development services, Manufacturing services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, ICH Stability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Impurity synthesis

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