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We are redefining the landscape of API manufacturing by prioritizing quality, innovation, and research. Committed to addressing global challenges in API availability, our mission is to ensure reliable and sustainable healthcare solutions. By bridging gaps in India’s API supply chain and addressing international demands, we aim to set benchmarks for excellence. Guided by integrity and a focus on progress over profit, we strive to build trust and deliver value worldwide through sustainable and dependable pharmaceutical solutions.

Dr. Ketan R. Patel

Chairman & Managing Director

Our Products

Why Troikaa Pharmachem?

Innovation drives our Research & Development efforts, creating solutions that shape the future of healthcare. Our dedicated R&D team specializes in drug discovery, process optimization, and novel formulation development. With cutting-edge technology and expertise, we transform ideas into impactful products, delivering excellence and advancing pharmaceutical science.

About us

API Manufacturing

We specialize in producing high-quality Active Pharmaceutical Ingredients (APIs) to meet global healthcare demands. With a focus on innovation, advanced research, and sustainability, our state-of-the-art facilities ensure precision and compliance at every step. From small-molecule NCEs to highly potent APIs, we deliver reliable and scalable solutions tailored to industry needs.
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Quality Control

Quality control is at the heart of our operations, ensuring every product meets stringent global standards. Equipped with advanced technology and rigorous protocols, our dedicated team ensures precision, compliance, and reliability at every stage. From raw material testing to final product validation, we uphold excellence to deliver safe, effective, and high-quality pharmaceutical solutions.
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API Contract Manufacturing

We deliver seamless end-to-end solutions as a trusted Contract Development and Manufacturing Organization (CDMO). From drug discovery and process development to commercial API supply, our expertise ensures flexibility, scalability, and precision. With specialized services like highly potent APIs, peptide products, and sterile manufacturing, we empower our clients to innovate faster and adapt to market demands efficiently.
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Our Products

Midazolam

Midazolam is a short-acting hypnotic-sedative with anxiolytic and amnestic properties, widely used in procedures like dentistry, cardiac surgery, and anesthesia. Its short action and cardiorespiratory stability make it ideal for elderly and high-risk patients. Administered through various routes (oral, intravenous, intramuscular, nasal, or buccal), its primary effects include sedation, anxiety reduction, muscle relaxation, amnesia, and anticonvulsant activity, making it essential in medical settings.

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Nefopam Hydrochloride

Nefopam Hydrochloride is a powerful non-opioid analgesic, known for its efficacy in relieving acute and chronic pain, including post-operative, dental, musculoskeletal, traumatic, and cancer pain. Our approach to the synthesis and production of Nefopam Hydrochloride sets us apart, ensuring superior quality, safety, and efficiency at every step.
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Rocuronium bromide

Rocuronium Bromide is a short-acting, non-depolarizing steroidal neuromuscular blocker commonly used alongside general anesthesia to facilitate endotracheal intubation and provide muscle relaxation during surgery or mechanical ventilation. Given its effect on neuromuscular function, a reversal agent, like Sugammadex, is often required to address potential residual paralysis post-procedure.
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Sugammadex Sodium

Sugammadex Sodium is a groundbreaking drug in the class of selective relaxant binding agents (SRBA), providing a safer, more efficient reversal of neuromuscular blockade caused by agents like Rocuronium and Vecuronium in general anesthesia. With significant peri-operative benefits, Sugammadex offers a superior solution for managing muscle relaxation during surgery.​
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Troikaa Pharmachem Pvt. Ltd.
Registered Office:
Troikaa House,
Satya Marg, Bodakdev,
Ahmedabad-380 054. Gujarat, India.

Corporate Identification Number: U24299GJ2021PTC127098

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Why Midazolam by Troikaa Pharmachem?

By combining advanced synthetic techniques, stringent impurity control, and a commitment to regulatory excellence, our Midazolam API stands out for its unparalleled quality, safety, and reliability. Our process is designed to meet the highest Pharmacopoeial standards, making it a trusted choice for pharmaceutical manufacturers worldwide.

Precision in API pharmaceutical manufacturing – where Innovation meets Excellence.M

Advanced Synthesis Process for Superior Quality
Our Midazolam API is synthesized through a multi-step organic synthetic process, meticulously developed using the Quality by Design (QbD) approach. We’ve optimized the synthesis by employing a telescopic approach in the final two steps, enhancing both yield and quality. Through careful identification and control of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs), we’ve consistently achieved the highest Pharmacopoeial grade product.
Our Midazolam production process is designed to meet the strictest regulatory guidelines, including those set by the ICH (International Council for Harmonisation). We proactively address potential risks, such as nitrosamine contamination, ensuring full compliance with global regulations. By integrating advanced monitoring and control systems, we consistently deliver a product that meets the expectations of the global pharmaceutical industry.
Our Midazolam API undergoes continuous review and optimization to ensure that it remains aligned with evolving standards in pharmaceutical quality and safety. This approach has enabled us to provide a trusted API that not only meets but often exceeds Pharmacopoeial standards.

Midazolam production integrates HAZOP as a cornerstone of our safety strategy. By identifying and mitigating risks at every stage, we maintain the highest safety standards. Comprehensive safety audits, critical parameter monitoring, and environmental safeguards ensure Midazolam manufacturing remains secure, efficient, and fully compliant with industry regulations.

Impurity control is paramount in the production of Midazolam. Our process ensures that most impurities are either not detected, below the limit of quantification (BLOQ), or present at negligible levels. Furthermore, we have successfully addressed two closely spaced impurities—Impurity A and Impurity G—keeping them well within the targeted limits of Pharmacopoeial standards.
In addition to standard impurity management, we rigorously test for Genotoxic, Nitrosamine, and Elemental impurities, ensuring that our Midazolam API meets or exceeds global regulatory standards for safety and quality. This comprehensive impurity control has resulted in a Midazolam product of superior purity, aligning with the strictest industry guidelines.
Sr. No. Types of impurities Number of impurities Common names of impurities
01 Unknown impurities 0 --
02 Degradation impurities 2 N-Oxide, Hydroxy-methyl midazolam
03 Genotoxic impurities 2 Dihydroquinazoline 3-oxide, quinazoline 3-Oxide
04 Process related impurities 3 Desfluoromidazolam, Dihydromidazolam, Aminomethylbenzodiazepine
05 Aggregated impurities 1 Midazolam Dimer
06 Literature impurities 11 OPRD 2023, US7776852B2, Acta Pharm. 2013
07 Nitrosamine impurities 4 N-Nitroso dihydromidazolam, N-Nitroso reduced midazolam, N-Nitroso N-Oxide Nitromethylene, N-Nitroso aminomethylbenzodiazepine
08 Elemental impurities 24 As per ICH Q3D
09 Isomer impurities 1 Midazolam 6-H isomer
10 Truncated Impurity (Deletion & Addition impurity) 0 --

Why Nefopam Hydrochloride by Troikaa Pharmachem?

Our commitment to advanced process innovation, rigorous safety protocols, and strict regulatory compliance ensures that Nefopam Hydrochloride produced by us not only meets but exceeds industry standards. By leveraging sophisticated technologies and scientific excellence, we provide a product that is both safer and more efficient, offering unparalleled value to our customers.

Precision in API pharmaceutical manufacturing – where Innovation meets Excellence.M

Innovative Synthesis Process
Our Nefopam Hydrochloride production utilizes a telescopic synthetic approach, drastically reducing downstream processing, cutting production time, and minimizing costs without compromising on quality. By leveraging cutting-edge research, we’ve meticulously designed the synthesis route to prevent the formation of nitrosamine and mutagenic impurities, which are potential health risks. This means you get a safer, purer product that adheres to the strictest regulatory standards.
We’ve adopted the Quality by Design (QbD) framework to optimize every aspect of the manufacturing process. From identifying Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensuring robust material management, our process guarantees reproducibility, consistency, and reliability. This not only enhances product quality but also significantly reduces the risk of variations, making us a leader in pharmaceutical precision.

Safety is paramount in the pharmaceutical industry, and we go beyond compliance to ensure our processes are the safest in the market. Through comprehensive risk assessments and the integration of advanced safety features, our Nefopam Hydrochloride synthesis process is built to prevent hazards at every stage. We employ HAZOP, a systematic approach to identifying and mitigating potential risks in our processes. This proactive measure allows us to anticipate and address safety concerns before they arise, ensuring a robust and fail-safe operational environment. Additionally, fail-safes for critical parameters and regular safety audits are conducted, ensuring both personnel safety and environmental protection.

We adhere to the highest regulatory standards, with an intense focus on nitrosamine, elemental, and genotoxic impurity control. Our rigorous evaluation identified Monomethylethanol amine (KSM-2) as a potential source of nitrosamine impurities. By synthesizing and analyzing the corresponding impurity (N-Nitrosomonomethylethanol amine), we ensure it remains undetectable in the final product, offering unmatched safety assurances.
Thanks to our advanced process development, we’ve significantly shortened production cycle times without compromising product quality. This efficiency enables us to deliver faster, more reliable results to our clients, providing a distinct competitive advantage in terms of both cost and speed.
Nefopam Hydrochloride sets a peerless benchmark in API quality. With zero unknown impurities and precise control of genotoxic, degradation, and elemental impurities, it exemplifies superior purity and innovation. Backed by cutting-edge technology and unmatched expertise, it defines pharmaceutical excellence beyond industry standards.
Sr. No. Types of impurities Number of impurities Common names of impurities
01 Unknown impurities 0 --
02 Degradation impurities 1 N-Oxide
03 Genotoxic impurities 3 IPMS, EO and Benzene
04 Process related impurities 4 Nefomide, Nefodiol, Deoxy, Ketomaine
05 Aggregated impurities 0 --
06 Literature impurities 4 OPRD 2017
07 Nitrosamine impurities 3 NDMA, N-Nitroso MMEA, N-Nitroso Desmethyl Nefopam
08 Elemental impurities 24 As per ICH Q3D
09 Isomer impurities 0 --
10 Truncated Impurities (Deletion & Addition impurity) 0 --

Why Rocuronium bromide by Troikaa Pharmachem?

With our cutting-edge synthesis process, stringent impurity control, and a robust commitment to regulatory compliance, we deliver a Rocuronium Bromide API that offers superior performance and safety. Our focus on quality ensures that every batch meets the highest industry standards, making it the preferred choice for pharmaceutical manufacturers seeking reliability and excellence.

Precision in API pharmaceutical manufacturing – where Innovation meets Excellence.M

Optimized Synthesis for Maximum Purity
Our Rocuronium Bromide API is synthesized through a highly refined, multi-step organic process that integrates the Quality by Design (QbD) methodology. This approach ensures each step of the synthesis is meticulously optimized to maintain high yields and exceptional product quality.
Due to the highly hygroscopic nature of Rocuronium Bromide, special attention is given to its isolation and storage conditions to prevent moisture-related degradation. This ensures product stability and integrity during both production and storage.

Our Rocuronium Bromide API is designed to exceed regulatory expectations. Through a combination of advanced process controls and state-of-the-art manufacturing technologies, we achieve a Pharmacopoeial grade product that stands out for its purity and consistency. Our commitment to Quality by Design (QbD), continuous process monitoring, and compliance with international regulatory standards makes us a trusted partner in the pharmaceutical industry.

The synthesis of Rocuronium Bromide is fortified by HAZOP, enabling us to proactively detect and address potential risks. This rigorous process ensures operational safety, supported by advanced safety features and routine audits. With HAZOP at the core, we deliver a reliable and safe product while safeguarding both personnel and the environment.

More than ten process-related and degradation impurities were identified from extensive literature review and in-house research. Each of these impurities is closely monitored and controlled to ensure that the final API meets stringent quality standards. Three key impurities—Impurity A, B, and C—which are known to affect both the process and product stability, have been successfully managed within the limits set by Pharmacopoeial guidelines.
In addition to regular impurity profiling, our Rocuronium Bromide undergoes comprehensive testing for Genotoxic, Nitrosamine, and Elemental impurities. By addressing these critical safety concerns, we ensure that our API meets global regulatory requirements, guaranteeing patient safety and product efficacy.
Sr. No. Types of impurities Number of impurities Common names of impurities
01 Unknown impurities 0 -
02 Degradation impurities 0 -
03 Genotoxic impurities 1 Allyl bromide
04 Process related impurities 4 O-allyl Rocuronium, 3-Acetyl Rocuronium Bromide, Desacetyl Rocuronium Bromide, Bis-Allyl Rocuronium
05 Aggregated impurities 0 -
06 Literature impurities 8 J. Chromatogr. A 2007
07 Nitrosamine impurities 0 -
08 Elemental impurities 24 As per ICH Q3D
09 Isomer impurities 0 -
10 Truncated Impurity (Deletion & Addition impurity) 0 -

Why Sugammadex Sodium by Troikaa Pharmachem?

Our advanced approach to Sugammadex Sodium manufacturing integrates deep scientific expertise, meticulous process development, and adherence to stringent regulatory guidelines. With a focus on ensuring the highest quality, safety, and regulatory compliance, our Sugammadex Sodium offers a trusted, high-performance solution for the medical community.

Precision in API pharmaceutical manufacturing – where Innovation meets Excellence.M

Innovative Chemistry for Enhanced Efficiency
At the core of Sugammadex Sodium is its unique chemical structure—a modified gamma cyclodextrin with a hydrophilic exterior and a lipophilic core. This structure is engineered with eight carboxyl thio ether groups, expanding the cavity size to encapsulate the Rocuronium molecule. These extensions create a strong electrostatic bond with the quaternary nitrogen of Rocuronium, ensuring rapid and effective reversal by preventing Rocuronium from binding to acetylcholine receptors at the neuromuscular junction. This makes Sugammadex’s binding encapsulation one of the most robust in its class, setting it apart as a highly efficient reversal agent.
Our Sugammadex Sodium synthesis is driven by the Quality by Design (QbD) methodology, ensuring that every step of the process is optimized for superior product quality. By carefully identifying and controlling Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and Critical Quality Attributes (CQAs), we have developed a highly reliable process that consistently meets quality standards. Additionally, since Sugammadex Sodium is sensitive to moisture, pH, and temperature, we’ve optimized the purification reaction to ensure desired quality without the need for complex procedures like preparative HPLC or TFF.

In producing Sugammadex Sodium, we employ HAZOP to meticulously assess and address potential safety risks. This structured approach ensures robust safety protocols across the process, preventing hazards before they occur. Coupled with regular audits and advanced fail-safe mechanisms, we deliver a safe and sustainable production environment that aligns with global safety standards.

Sugammadex Sodium is developed with precision to exceed regulatory standards. Rigorous sameness studies with Bridion ensure compliance with USFDA guidelines, validating equivalence in key physicochemical properties. Every aspect of production reflects our expertise and dedication to delivering products that meet global regulatory expectations.
With a focus on impurity control, Sugammadex Sodium ensures exceptional quality and safety. Advanced analyses confirm impurity levels equal to or below those in Bridion, addressing genotoxic, nitrosamine, degradation, and elemental impurities. Fully compliant with global standards like ICH Q3D, it exemplifies superior purity and regulatory excellence.
Sr. No. Types of impurities Number of impurities Common names of impurities
01 Unknown impurities 0 --
02 Degradation impurities 3 Dia-1 of Sulfoxide, Dia-2 of Sulfoxide, Disulfide
03 Genotoxic impurities 1 Benzene
04 Process related impurities 2 Mono bromo & Mono hydroxyl impurity
05 Aggregated impurities 0 --
06 Literature impurities 2 Chromatography, 2022
J Pharm Biomed Anal, 2022
07 Nitrosamine impurities 1 NDMA
08 Elemental impurities 24 As per ICH Q3D
09 Isomer impurities 0 --
10 Truncated Impurities (Deletion & Addition impurity) 0 --