Plot no 105, Part A, Karnataka Industrial Area Development Board, Humnabad, Karnataka 585330
CDMO & JOB WORK

API Contract Manufacturing &
CDMO Job Work Services

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Delivering end-to-end pharmaceutical contract manufacturing, process development, pilot scale-up, commercial production, and technology transfer with GMP-compliant quality standards.

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API Custom Manufacturing Facility
CDMO & JOB WORK

Your Trusted Partner for
Custom Manufacturing

Kalpasthana Life Care Products is a premier GMP-compliant CRAMS partner based in Karnataka, offering custom organic synthesis, process scale-up, and ton-scale contract manufacturing. We serve domestic and international pharma clients, providing cost-effective route optimization and reliable job work services from our state-of-the-art facility in Humnabad. Guided by rigorous IP protection protocols and ISO-compliant operations, we act as a secure extension of your laboratory, bridging the gap between clinical research batches and full commercial scale-up runs with speed, stability, and absolute analytical precision.

Custom Synthesis
Process Scale-Up
Technology Transfer
Commercial Manufacturing
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Workflow & Engineering

Our Manufacturing Process

Step 01

R&D

Literature checks and synthetic pathway design.

Step 02

Process Dev

Synthetic pathway optimization and yield checks.

Step 03

Pilot Scale

Initial scale-up runs to validate process stability.

Step 04

Commercial Mfg

Bulk production inside SS and glass-lined reactors.

Step 05

Quality Control

HPLC purity testing and certificate compilation.

Step 06

Packaging

Double polythene lining inside UN-approved drums.

Step 07

Delivery

Secure domestic dispatch and global port transport.

TECHNICAL KNOWLEDGE HUB

Deep-Dive CDMO Capabilities & Reference

Explore our in-depth technical portfolio, covering advanced reaction mechanisms, engineering parameters, quality management protocols, and regional logistics integration.

Strategic Logistics & Regional Hub Integration

In the pharmaceutical contract development and manufacturing (CDMO) ecosystem, geographic positioning is not merely a matter of convenience; it is a critical driver of supply chain resilience, velocity, and regulatory alignment. Kalpasthana Life Care Products operates a GMP-compliant manufacturing facility strategically located in the Humnabad Industrial Area (KIADB), Bidar District, Karnataka, India. This location acts as a key logistical nexus, situated directly along National Highway 65 (NH-65), which connects major commercial, chemical, and pharmaceutical hubs across India, specifically Hyderabad, Pune, Mumbai, and Bengaluru.

Hyderabad Corridor
140 km
Bidar District Hub
50 km
Pune Corridor
420 km
Mumbai Seaport
560 km
Bengaluru Biotech
610 km

Logistical Transit & Sourcing Corridors:

Hyderabad (Pharma Capital Corridor) 140 km (Under 3 Hrs)

Humnabad is uniquely positioned near Hyderabad, Telangana, which is globally recognized as the "Bulk Drug Capital of India." Located approximately 140 kilometers from Hyderabad's premier pharmaceutical industrial corridors—including Jeedimetla, Patancheru, Pashamylaram, and the Hyderabad Pharma City—our facility serves as an immediate, high-capacity extension for Hyderabad-based pharmaceutical manufacturers. This close proximity enables seamless, same-day transfer of critical Raw Materials (RMs), Key Starting Materials (KSMs), and intermediate compounds. Furthermore, technical teams and research scientists from Hyderabad can conduct on-site audits, technology transfer discussions, and joint engineering trials without the logistical overhead associated with remote facilities.

Maharashtra Industrial Corridor (Pune & Mumbai) 420 - 560 km

Beyond Hyderabad, our strategic positioning connects us directly to the industrial and chemical clusters of Maharashtra, including Pune and Mumbai. These cities house some of India's largest chemical manufacturer bases, solvent storage terminals, and specialized reagent distributors. Through the NH-65 and NH-161 transit corridors, we maintain direct logistics lines for bulk solvent deliveries and hazardous reagents, ensuring that our commercial operations are never interrupted by material shortages. Similarly, our proximity to Bengaluru, Karnataka—a global biotechnology and R&D capital—allows us to collaborate closely with formulation research centers, biotechnology laboratories, and clinical development firms requiring rapid pilot-scale custom synthesis under strict non-disclosure agreements.

Humnabad KIADB Support & Energy Ecosystem Local Sourcing

Humnabad's KIADB industrial estate is positioned alongside the critical energy and gas pipelines traversing central India. This guarantees that our energy requirements, including natural gas and high-voltage power grids, are maintained with zero interruption. For long-term projects, client technical groups can travel from Hyderabad, Mumbai, or Pune, arriving at our site via national highways in a matter of hours. The proximity also ensures that critical equipment parts, custom glassware, and specialized reactor vessels can be fabricated and delivered on a same-day timeline from nearby heavy engineering zones in Hyderabad and Bidar. This localized support ecosystem minimizes shutdown durations, speeds up preventive maintenance cycles, and ensures high availability of our reactor capacities for custom chemical campaigns. Our supply chain group works with local transit partners to coordinate logistics for liquid bulk products, utilizing stainless steel tankers and specialized intermediate bulk containers (IBCs) with full thermal control.

Logistical Advantages of Humnabad KIADB Corridor:

Airport Proximity

Rapid air cargo access via Rajiv Gandhi International Airport in Hyderabad (HYD) ensures domestic and international transit of high-value intermediates under controlled temperatures.

KIADB Infrastructure

KIADB Humnabad provides robust industrial power lines, dedicated industrial water allocation, and localized hazardous waste management networks, ensuring continuous plant operations.

Same-Day Audits

Ability to host same-day technical audits and joint process-scouting sessions with client QA/QC and research heads from nearby pharma capitals.

Transit Redundancy

Parallel highway routes and nearby rail connections enable reliable, high-volume shipping of raw materials and finished intermediates.

Pharma / Chemical Hub Approx. Distance Logistical Transit Significance
Hyderabad (Telangana) 140 km Immediate access to bulk drug manufacturing, commercial QA labs, and key starting materials (KSMs).
Bidar (Karnataka) 50 km Local industrial support, secondary engineering workshops, and regional analytical laboratories.
Pune (Maharashtra) 420 km Direct sourcing of specialized organic reagents, catalyst suppliers, and engineering equipment.
Mumbai (Maharashtra) 560 km Proximity to JNPT seaport for export of commercial batches and import of raw materials from international suppliers.
Bengaluru (Karnataka) 610 km Direct integration with R&D laboratories, formulation centers, and clinical development organizations.

Advanced Synthetic Chemistry & Reaction Mechanics

Our core technical competence lies in our capability to execute complex, multi-step organic syntheses from laboratory-scale verification to commercial-scale multi-ton campaigns. Our synthetic chemistry team possesses specialized expertise in handling highly reactive reagents, managing thermodynamic parameters of exothermic processes, and achieving high regioselectivity and stereochemical control in custom molecule job work.

Grignard Dosing Temp.
-10°C to 0°C
Grignard Moisture Limit
< 500 ppm
High-Temp Reflux Cap.
Up to 250°C
Hydrazine Prep Temp.
Below 5°C
Intermediate HPLC Purity
> 99.5%

Specialized Chemical Syntheses & Engineering Controls:

Grignard Chemistry (Organomagnesium Syntheses)

Inert Nâ‚‚ Purged
Solvent Moisture: < 500 ppm Initiation Temp: -10°C to 0°C Safety: Automated Dosing

Grignard reactions represent a cornerstone of our synthesis portfolio. Executing organomagnesium reactions at a commercial scale requires strict exclusion of atmospheric moisture, precise control over solvent dryness, and intensive management of initial reaction initiation. Our engineering setup utilizes dedicated, nitrogen-purged reactor vessels with automated reagent dosing systems. We routinely prepare and react Grignard reagents such as methylmagnesium chloride, ethylmagnesium bromide, and phenylmagnesium bromide in dry tetrahydrofuran (THF) or diethyl ether. We perform inline moisture checks using Karl Fischer titration to ensure the solvent moisture content remains consistently below 0.05% (500 ppm). Heat jacket systems are capable of maintaining constant sub-zero temperatures (0°C to -10°C) during alkyl/aryl halide addition to prevent side reactions and maintain safe thermodynamic profiles.

Friedel-Crafts Alkylation & Acylation

HCl Gas Scrubber
Catalysts: Anhydrous AlCl3, FeCl3, BF3 Feeding: Closed Solid Charger Materials: Glass-Lined Reactors

We handle electrophilic aromatic substitutions under aromatic systems using high-purity catalysts such as anhydrous aluminum chloride (AlCl3), iron(III) chloride (FeCl3), and boron trifluoride (BF3). Our facilities feature automated solid-charging systems to safely introduce catalyst powders without exposing them to air or moisture. Our reaction control systems mitigate the risks of runaway exotherms and corrosive off-gas generation by utilizing integrated hydrochloric acid (HCl) gas scrubbing towers. This setup ensures that acidic vapors are neutralised instantly, preserving equipment integrity and ensuring absolute compliance with occupational safety and environmental emission limits. We excel in selective mono-acylation and alkylation of carbazoles, cyclohexanediones, and diphenyl derivatives.

Specialized Heterocyclic Chemistry

HPLC Monitored
Carbazole Prep Purity: > 99.5% Catalyst: Phase-Transfer (BTEAC) Solvents: Toluene / DMF

We have established a proprietary technological platform for carbazole and hydrazine derivatives. We regularly synthesize key starting materials (KSMs) and intermediates for high-demand APIs such as Ondansetron and Carvedilol. In our heterocyclic synthesis operations, the alkylation of carbazoles represents a critical pathway. For example, during the manufacture of 9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one, we react the carbazolone precursor with dimethyl sulfate or methyl iodide under phase-transfer catalysis using benzyltriethylammonium chloride in toluene or dimethylformamide. The reaction conversion is monitored hourly using thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC). Upon completion, the organic layer undergoes water washing and crystallization from methanol, yielding a white to off-white crystalline solid with a melting point of 188-190°C.

High-Temp Chemistry & Catalytic Reductions

250°C Boiler Cap
Bechamp Reduction: Fe/Acid Transfer Hydrogenation Green Solvents Selected

Our thermic fluid boiler systems supply heat up to 250°C, allowing us to perform prolonged high-temperature reflux condensations, decarboxylations, and esterifications. We also execute chemical reductions of nitro groups to primary amines using iron/acid (Bechamp reduction) or catalytic transfer hydrogenation. Every campaign is backed by route scouting to select green solvents, improve atom economy, and reduce solid waste generation.

Specialized Intermediates and Synthesis Protocols:

Ondansetron Intermediates

We manufacture 9-Methyl Carbazolone and 1,2,3,9-Tetrahydro-4H-carbazol-4-one. Our process uses phase-transfer catalysts and high-vacuum crystallization for purity levels exceeding 99.5% by HPLC. For cyclohexanedione chemistry, 1,3-cyclohexanedione is prepared via catalytic hydrogenation of resorcinol in alkaline media, requiring strict pH controls to prevent self-condensation.

Carvedilol Intermediates

We supply high-purity 4-Hydroxycarbazole and Phenyl Hydrazine Hydrochloride. Synthesis of 4-hydroxycarbazole involves selective nitration and catalytic reduction. Phenyl hydrazine hydrochloride is prepared via aniline diazotization and reduction, requiring strict temperature control below 5°C to prevent diazonium decomposition.

GMP Manufacturing Infrastructure & Process Scale-Up

Transitioning a chemical synthesis from a lab bench (grams) to a commercial plant (tons) requires rigorous chemical engineering, detailed heat and mass transfer analysis, and standard equipment protocols. At Kalpasthana Life Care Products, our Humnabad manufacturing plant is engineered to support seamless scale-up services. We operate dedicated pilot plant facilities and commercial production bays containing a versatile array of glass-lined and stainless steel reactors.

Glass-Lined Reactors (GLR)
500L - 5,000L
Stainless Steel Reactors (SSR)
500L - 5,000L
Steam Boiler Capacity
3 Tons/Hr
Brine Unit Utility
-15°C Min
Dryer Room Rating
ISO Class 8

Interactive Reactor Comparison Matrix:

Glass-Lined Reactors (GLR)

Corrosive Service & Acid Resistance: GLR vessels are critical for corrosive chemistries involving strong mineral acids, halogenating reagents, or acidic catalysts (e.g., AlCl3, HCl, H2SO4), where metallic contamination must be strictly prevented. Lined with high-durability chemical glass.

Operating Temperature Range -15°C to +200°C
Capacity Spectrum 500L to 5,000L
Anchor Impellers Corrosion Resistant
Stainless Steel Reactors (SSR-316)

High-Pressure & General Synthesis: SSR-316 reactors are utilized for basic, neutral, and high-pressure reactions, including amine synthesis, esterifications, and solvent extractions. High structural integrity and rapid thermal transfer rate.

Operating Temperature Range -15°C to +250°C
Capacity Spectrum 500L to 5,000L
Turbine/Pitch-Blade High Pressure

Thermal Control and Utility Integration:

Thermic Fluid Systems

Direct supply of hot oil heating up to 250°C, supporting high-temperature cyclizations and high-vacuum distillations. Fast jacket transition (heating to brine) is automated.

Sub-Zero Brine Unit

Sub-zero refrigeration units supplying brine down to -15°C to reactors, allowing safe control of highly exothermic reactions like nitrations and organometallic additions.

Vacuum Systems

Multi-stage dry vacuum pumps and steam ejectors achieving vacuums down to 1 mmHg, enabling low-temperature distillation of heat-sensitive intermediates.

Explosion-Proof Facility

Spark-free engineering designs and flameproof electrical installations conforming to Class I, Division 1 standards to process volatile solvents safely.

Downstream Processing and Powder Processing:

Isolating the final product in its desired crystalline form and particle size distribution is critical for subsequent formulation steps. At Kalpasthana, our downstream processing section ensures absolute purity:

Solid Isolation

We utilize centrifuge machines (top discharge and bag-lifting) to separate solids from mother liquors. Lined with high-durability polymers and SS-316L to resist acidic solvents and chlorides.

Enclosed Filtration

For sensitive intermediate isolation, we utilize Agitated Nutsche Filter Dryers (ANFD) that perform filtration, washing, and vacuum drying within a single enclosed vessel, eliminating atmospheric exposure.

Drying Operations

For bulk chemical drying, we utilize Vacuum Tray Dryers (VTD) and Rotary Cone Vacuum Dryers (RCVD) under strictly monitored thermal limits to prevent thermal degradation of active intermediates.

GMP Quality Management Systems & Analytical Control

In custom CDMO manufacturing, quality assurance is integrated into every phase of our operations, from raw material receipt to final product dispatch. We operate in strict compliance with Good Manufacturing Practice (GMP) guidelines, ensuring that every batch is fully traceable, reproducible, and compliant with global pharmaceutical standards (such as ICH Q7).

Regulatory Standard
ICH Q7 GMP
Retention Samples
5 Years
Method Validation
ICH Q2(R1)
Final Packing Area
ISO Class 8
Stability Chamber Zones
Zone II & IV

Operational Quality Pillars:

Quality Assurance (QA) Operations

Our QA department operates independently from the production division to guarantee unbiased oversight of plant operations. We implement a comprehensive documentation system based on Master Batch Production Records (MBPR) and executed Batch Manufacturing Records (BMR).

  • BMR records material addition weights, temperature charts, and in-process testing in real-time.
  • Strict protocols for Change Control management, Deviation handling, OOS investigations, and CAPA tracking.
  • Retention sample warehouse stores raw materials, intermediates, and APIs at 25°C ± 2°C & 60% ± 5% RH for 5 years.
  • Stability chambers for Zone II/IV stability studies (25°C/60% RH, 30°C/65% RH, and accelerated 40°C/75% RH).
  • Annual Product Reviews (APRs) to identify trends, evaluate consistency, and drive continuous improvements.

Analytical Quality Control (QC) Lab

Our in-house QC laboratory is equipped with state-of-the-art analytical instrumentation to perform chemical analysis, purity profiling, and structural confirmation. Method validation conforms strictly to global standards.

  • Method validation executed in accordance with ICH Q2(R1) guidelines.
  • High accuracy, precision, linearity, and specificity established for all active chemical assays.
  • Specificity testing includes mapping of process-related impurities and synthetic intermediate degradation paths.
  • Strict limit of detection (LOD) and limit of quantitation (LOQ) mapped at parts-per-million (ppm) levels.
  • Independent release authorization required from QA Head prior to raw material charging or batch dispatch.

Advanced Analytical Equipment in our QC Lab:

HPLC Systems

High-Performance Liquid Chromatography equipped with UV-Vis and PDA detectors for high-resolution determination of chemical purity and impurity profiling.

Headspace GC

Gas Chromatography equipped with Flame Ionization Detectors (FID) and headspace samplers, primarily utilized for residual solvent analysis (ICH Q3C limits).

Karl Fischer

Automated volumetric and coulometric systems for precise moisture content determination in solvents, KSMs, and final products.

Stability Chambers

Climatic chambers for real-time and accelerated stability studies (Zone II/IV, 40°C/75% RH) to monitor degradation profiles.

Cleanroom Facilities & Packaging (ISO Class 8)

To ensure that final intermediates and bulk products are free from particulate and environmental contamination, our isolation, drying, milling, and packaging operations are conducted in ISO Class 8 (Class 100,000) cleanrooms. These rooms feature dedicated Air Handling Units (AHUs) with HEPA filtration, differential pressure controls, double-door pass boxes, and epoxy-coated flooring, ensuring absolute protection of product integrity before final packaging.

Technology Transfer, IP Protection & Vendor Qualification

Successful CDMO partnerships are built on a foundation of operational transparency, secure technology transfer, and absolute protection of intellectual property (IP). At Kalpasthana Life Care Products, we understand that client formulations and synthesis routes represent high-value intellectual assets. We have designed our business processes to ensure complete confidentiality and security throughout the life of our partnership.

IP Protection Method
Segregated Server
Confidentiality Protocol
Bilateral NDA
Cleaning Assessment
MACO / ADI limits
Supply Security
Dual KSM channels
Hazard Audit Code
HAZOP Method

Standardized Technology Transfer Protocol (TTP):

We utilize a structured technology transfer workflow to transition client processes from R&D scale to our manufacturing floor. Each stage is strictly managed to optimize yield and ensure safety:

Step 1: Gap & Safety Assessment
Intake & Feasibility Scouting

Upon receipt of technical documentation, our process development group conducts a thorough Gap Analysis and Hazard Assessment. We evaluate safety limits, chemical hazards, solvent compatibilities, and initial safety protocols.

Step 2: Lab Verification Trials
Route Validation & Lab Scouting

We execute lab-scale trials (50g to 1kg) in our R&D lab to confirm yield profiles, cycle times, reaction thermodynamics, and analytical chromatography curves.

Step 3: Technical Dossier Compilation
Tech Transfer Dossier (TTD) Formulation

Once lab validation is complete, we generate a comprehensive Tech Transfer Dossier (TTD) including scale-up hazard assessments, process safety parameters, material balance charts, cleaning validation protocols, and HAZOP study logs.

Step 4: Scale-up Campaign Locking
Pilot-Scale Validation & Scale-Up

Chemical engineers, safety officers, and chemists systematically evaluate deviation scenarios (e.g., cooling failure, agitator stop, overcharging) via HAZOP and run initial validation trials in 500L–1,000L reactors before locking commercial scale.

Intellectual Property (IP) Protection & Containment:

We implement rigorous IP protection protocols to safeguard client trade secrets and proprietary synthesis pathways:

Strict NDAs

We execute legally binding bilateral NDAs before discussing any technical details, safeguarding target files and chemical processes.

Segregated Access

Custom synthesis campaigns are conducted in campaign-specific equipment with restricted access. Files are stored on secure servers with role-based restrictions.

Code Masking

Raw materials and intermediates for proprietary molecules are labeled with unique internal codes to prevent public disclosure of active structures.

Cleaning Validation

Cleaning protocols calculated using ADI and MACO safety limits. Swab analysis via validated HPLC methods ensures cross-contamination protection.

Vendor Qualification & Supply Chain Integrity

We source starting materials, specialized reagents, and solvents exclusively from qualified, audited vendors in India and global markets. We maintain active dual-sourcing arrangements for critical starting materials (KSMs) to mitigate supply chain risks. Every incoming raw material batch undergoes complete QC testing against predefined monographs before being admitted into our raw material warehouses, guaranteeing that our production begins with optimal materials.

ADVANCED CHEMISTRY

Specialized Reactions

Our facility and team of experts are equipped to safely handle a wide spectrum of complex chemistries and hazardous reagents.

Friedel-Crafts Alkylation & Halogenation

Handling anhydrous aluminum chloride and other Lewis acids under strictly controlled moisture-free environments, alongside specialized containment systems for executing chlorination and bromination processes safely at bulk scale.

Nitration & Reduction

Controlled handling of nitric acid mixtures, followed by catalytic hydrogenation or chemical reduction techniques.

Grignard Reactions

Large-scale preparation and safe execution of organomagnesium compounds under inert nitrogen atmospheres.

Condensation Synthesis

High-yield multi-step condensation processes requiring precise temperature control and prolonged reflux operations.

High-Temp Chemistry

Thermic fluid systems capable of sustaining high-temperature reactions up to 250°C consistently over prolonged cycles.

TECHNICAL CAPABILITIES

CDMO Manufacturing Expertise

Commercial Manufacturing

We operate specialized multi-purpose manufacturing blocks designed to support ton-scale commercial API campaigns. Our plant houses a combined reactor volume of 50 kL, consisting of stainless steel (SSR) and glass-lined (GLR) vessels ranging from 500L to 5,000L.

Every commercial run is governed by validated cleaning protocols (calculated via MACO and ADI parameters) and complete cGMP documentation, ensuring full compliance and batch traceability required for global procurement audits.

Manufacturing Footprint
  • 50 kL Combined Capacity
  • Glass-Lined Reactors (GLR)
  • Stainless Steel Vessels (SSR)
  • Operating Range: 500L to 5,000L
Development Toolkit
  • Design of Experiments (DoE)
  • Route Scouting & Synthesis
  • Purity Profile Verification
  • Synthetic Yield Optimization

Process Development

Our R&D group conducts chemical route validation and process optimization for proprietary molecules and generic APIs. We utilize Design of Experiments (DoE) and state-of-the-art Process Analytical Technology (PAT) to optimize synthetic parameters.

We focus on replacing hazardous reagents, improving solvent recovery efficiency, and locking yield metrics, ensuring synthetic steps are cost-effective, scalable, and safe for subsequent industrial campaigns.

Pilot Scale Support

We operate a dedicated pilot scale-up plant designed to bridge the gap between laboratory synthesis and full-scale commercialization. Our pilot reactors (500L to 1,000L capacity) allow us to execute scale-up trials (50kg to 500kg campaigns).

These campaigns verify thermodynamic profiles, mass balance equations, and filtration rates, generating crucial scale-up safety audits and material batches for validation checks.

Scale-Up Parameters
  • 50kg - 500kg Scale-Up runs
  • Dedicated Pilot Line (500L-1,000L)
  • Critical Parameter Locking
  • Batch Validation Sampling
IP & Transfer Safeguards
  • Bilateral NDAs & Safe Silos
  • Analytical Method Validation (AMV)
  • Campaign-Specific Restrictions
  • Raw Material Code Masking

Technology Transfer

We execute structured Technology Transfer Protocols (TTP) to ensure seamless migration of processes to Humnabad. Each transition campaign is led by dedicated tech transfer engineers collaborating with client technical teams.

All proprietary synthetic routes, raw material specs, and analytical validation documents (AMV) are handled under secure bilateral Non-Disclosure Agreements (NDAs), ensuring complete IP protection.

Core CDMO Services

Comprehensive solutions spanning from process development to high-volume commercial manufacturing.

Process R&D

Route scouting, process optimization, and yield enhancement. We refine complex lab-scale processes, utilizing DoE to ensure robustness, purity, and cost-efficiency prior to commercial scale-up.

Commercial Scale-Up

Seamless transition from pilot plant to multi-ton commercial production. Dedicated blocks equipped with GLR and SSR reactors handle aggressive and multi-step synthesis safely.

Tech Transfer

We operate under stringent Non-Disclosure Agreements (NDAs). Our dedicated tech transfer teams ensure that your proprietary formulations and IP remain completely secure.

Advanced Infrastructure & QA

GMP-compliant facilities designed to consistently meet stringent global regulatory standards.

GLR & SSR Reactors

From 500L pilot scales to 5,000L commercial capacities, offering unmatched versatility.

GMP Documentation

Complete batch traceability, exhaustive SOPs, and validation protocols ensuring audit readiness.

Analytical Precision

In-house QA/QC labs equipped with state-of-the-art HPLC, GC, and wet analysis setups.

Sustainable EHS

Robust effluent treatment plants (ETP) and comprehensive worker safety protocols.

WHO WE SERVE

Industries & Clients We Partner With

We provide API job work and custom synthesis to pharmaceutical manufacturers, API producers, and chemical companies across India.

API Manufacturers

Pharma companies needing API job work on carbazole, cyclohexanedione, and hydrazine chemistry. We handle synthesis you cannot do in-house.

Research Institutions

Universities and R&D organizations needing custom synthesis of specific intermediates in kilogram quantities for clinical or research programs.

Export-Oriented Pharma

Companies exporting Ondansetron, Carvedilol, and Frovatriptan APIs to regulated markets who need a reliable Indian KSM and intermediate partner.

COMMON INQUIRIES

Frequently Asked Questions

Find answers to standard technical questions about our manufacturing infrastructure, IP protection, and custom synthesis capabilities.

What are your reactor capacities for contract manufacturing?

Our facility features state-of-the-art Glass-Lined Reactors (GLR) and Stainless Steel Reactors (SSR) ranging from 500L (ideal for process R&D and pilot scale-ups) up to 5,000L commercial capacities, offering maximum flexibility for B2B bulk chemical production.

How do you protect intellectual property (IP) for custom synthesis?

IP protection is a core pillar of our CDMO services. We execute binding Non-Disclosure Agreements (NDAs) prior to receiving target files. All reaction routes, process parameters, and batch logs are stored securely, ensuring that proprietary formulations remain completely confidential and secure.

What specialized chemical reactions can you execute at scale?

Our chemical synthesis plant regularly handles complex chemistries at scale. Our specialties include Friedel-Crafts alkylations/acylations, halogenations (chlorination/bromination), controlled nitration, catalytic reduction, Grignard reactions, and prolonged high-temperature reflux condensation up to 250°C.

Are your manufacturing processes GMP-compliant?

Yes, all contract manufacturing operations are conducted in GMP-compliant plants in Humnabad, Karnataka. We implement exhaustive SOPs, run rigorous QA/QC wet labs equipped with HPLC/GC analyzers, and maintain complete batch records for absolute traceability and regulatory compliance.

What is the minimum order quantity (MOQ) for API job work?

For standard API job work on molecules within our existing chemistry expertise (carbazole, cyclohexanedione, and hydrazine derivatives), the minimum batch size starts at 25 kg. For new custom molecules requiring process development, we begin with lab-scale trials (50 g – 1 kg) before agreeing on a commercial MOQ. We are flexible for long-term partnership agreements.

Do you provide contract manufacturing services for Ondansetron and Carvedilol intermediates?

Yes. We are an established manufacturer of key intermediates for Ondansetron (9-Methyl Carbazolone, 1,2,3,9-Tetrahydrocarbazolone) and Carvedilol (4-Hydroxycarbazole, 1,2,3,9-Tetrahydrocarbazolone, Phenyl Hydrazine Hydrochloride). Pharma companies can source these on a job work basis or partner with us for dedicated batch production under a supply agreement.

How long does the contract manufacturing process take from inquiry to first delivery?

For known molecules within our chemistry portfolio, the typical timeline is: NDA & Technical review (1–3 days) → Lab trial (7–14 days) → Pilot scale-up (2–4 weeks) → First commercial batch (4–8 weeks). For new custom molecules requiring full process development, timelines are discussed after an initial feasibility assessment. We prioritize transparent communication throughout.

What states and regions in India do you supply to?

We supply API job work and contract-manufactured chemicals across India — primarily to pharmaceutical hubs in Hyderabad (Telangana), Bengaluru (Karnataka), Mumbai (Maharashtra), Ahmedabad (Gujarat), and Delhi NCR. International export to South Asian and global pharma companies can be arranged with appropriate regulatory documentation.

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We are a leading API intermediate manufacturer in India, committed to delivering top-quality pharmaceutical and healthcare solutions globally.

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