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R&D/F&D

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Research and development (R&D) is essential for pharma API manufacturing companies to stay ahead of the curve and meet the growing demand for new and innovative molecules.

Cerata Pharmaceuticals LLP has transformed into a preferred partner for APIs through a journey of dedication and excellence. Our competent and qualified R&D team specializes in developing innovative processes and continuously optimizing them, allowing us to maintain our competitive leadership position in the industry. Our two cutting-edge API R&D facilities strategically situated in Gujarat, India, serve as the pillars of our success. These facilities consistently strive for:

Innovation Excellence:

Our R&D teams are at the forefront of pharmaceutical innovation. They are committed to pushing the boundaries of knowledge, exploring novel synthetic routes, and adopting advanced technologies to develop APIs that stand out for their quality, safety, and efficacy.

Quality Assurance:

Ensuring the highest standards of quality is embedded in our DNA. Our R&D facilities are equipped with state-of-the- art analytical instruments and testing protocols, guaranteeing that our APIs meet and exceed the stringent quality benchmarks demanded by the industry and regulatory authorities.

Speed to Market:

We recognize the urgency of delivering life-saving medications to patients worldwide. Our R&D teams work diligently to shorten development timelines, allowing us to respond promptly to market needs and emerging healthcare challenges.

Sustainability:

Environmental responsibility is a fundamental principle guiding our operations. Our R&D facilities prioritize sustainable manufacturing processes, adhering to eco-friendly practices that contribute to a greener and more sustainable pharmaceutical industry.

Global Regulatory Compliance:

With a deep understanding of international regulatory frameworks, our R&D facilities ensure that our APIs meet the diverse regulatory standards of markets worldwide, providing confidence to our partners and customers.

Collaborative Partnerships:

We actively foster collaborations with renowned academic institutions, research organizations, and industry experts. These partnerships create a culture of open innovation, enabling us to leverage collective expertise and stay at the forefront of pharmaceutical advancements.

Through unwavering commitment to innovation, quality, sustainability, and global compliance, we are shaping a healthier future for patients worldwide, one API at a time."

API Research & Development Process Flow

Our Working Process

01
Idea Conceptualisation
02
Prototype Developments
03
Pilot, CT & Stability studies
04
Scale-up & PlantScale Validation
05
Commercialise &Launch
At our advanced analytical laboratory, we have an experienced and qualified team of scientists who are deeply committed to their work. Their expertise encompasses a wide range of critical functions, including

1. Analytical Method Development, Calibration, and Validation:

Our scientists are adept at developing, calibrating, and validating analytical methods to ensure the precision and reliability of our results.

2. Structural Identification and Elucidation:

They excel in identifying and elucidating the structures of various compounds, a crucial aspect of drug development.

3. Impurity, Byproduct, and Metabolite Isolation:

Within our laboratory, we have the capability to isolate and characterize impurities, byproducts, and metabolites, which is essential for maintaining the purity of pharmaceutical products.

4. Analytical Technology Transfer and Documentation:

We facilitate seamless technology transfer and maintain meticulous documentation practices to meet stringent regulatory standards.

5. Stability Studies as per ICH Guidelines:

Our laboratory conducts stability studies following the guidelines established by the International Council for Harmonisation (ICH), ensuring the consistent quality of our products over time.

Our Analytical Development laboratory is equipped with state-of-the-art specialized equipment including High- Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography-Mass Spectrometry (LCMS), Gas Chromatography-Mass Spectrometry (GCMS), Flash-Chromatography, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Particle Size Analyzers, Nuclear Magnetic Resonance (NMR) spectrometers, and various other essential tools such as colourimetry, auto-titrators, and stability chambers.

This comprehensive infrastructure empowers our team to deliver precise and high-quality analytical services, playing a pivotal role in pharmaceutical development and ensuring the highest standards of product quality and safety."

Process Safety Studies

We prioritize the creation of inherently secure procedures. To facilitate this, our state-of-the-art Process Safety Laboratory, complementing our Process Chemistry lab, plays a pivotal role. This specialized facility is equipped with cutting-edge capabilities and infrastructure, including:

1. Health and Environmental Hazards:
  • Health and environmental hazards are identified through the in-house SDS generated through GHS-compliant software.
2. Chemical Reaction Hazards data generation and its interpretation :
  • 1. The chemical reaction hazards that may be generated during the chemical processing/storage. The three majo r
  • 2. Exothermic reactions which raise the temperature to produce decomposition reactions or violent boiling
  • 3. Gas evolution
  • A dedicated team equipped with advanced laboratory equipment conducts different process safety studies.
  • 1. Thermal stability studies using
  • 2. Exothermic Reaction Studies using
  • 3. Gas Evolution and Vent Sizing Studies using
3. Fire and Explosion Hazards:
  • We carry out thermal stability tests and other fire and explosion tests, especially for powder safety testing.
4. Material Safety Management and Product Stewardship:
  • At Cerata Pharma, our commitment to safety extends to our comprehensive Safety Data Sheet (SDS) database, encompassing all GHS-compliant products and chemicals in use. In line with our 'Responsible Care' ethos, we've developed in-house capabilities to efficiently retrieve and generate new Material Safety Data Sheets (MSDS) for our developmental products. This capability not only reinforces our dedication to responsible material safety management but also plays a pivotal role in establishing robust product stewardship practices for both existing and new products. It empowers our employees and customers with the necessary information and guidelines to ensure safe and responsible handling of our chemicals and products, underlining our commitment to their well-being and safety."

Waste Pre-treatment Studies :

Our waste pre-treatment studies aim to reduce the environmental load at the process design stage while targeting various environmentally important parameters such as:

  • 1. COD
  • 2. BOD
  • 3. TSS
  • 5. TDS
  • 4. pH
  • 6. Ammoniacal Nitrogen content
  • 1. Bromide content
  • 2. Chloride content
  • 3. Sulphate content
  • 4. Metal content

Standard Operating Procedures :

This SOP applies to all personnel involved in the manufacture of pharma APIs. Responsibilities:

  • The Quality Assurance (QA) Manager is responsible for approving and maintaining this SOP.
  • The Production Manager is responsible for ensuring that all personnel involved in the manufacture of pharma APIs are trained on this SOP and that manufacturing operations are conducted in accordance with this SOP.
  • All personnel involved in the manufacture of pharma APIs are responsible for following this SOP.

Procedure:

1. Receive and inspect raw materials:
  • Raw materials must be received from approved suppliers and inspected for damage and quality before being accepted into the manufacturing area.
  • Raw materials must be stored in a designated area under appropriate conditions.
2. Weigh and measure raw materials:
  • Raw materials must be weighed and measured accurately using calibrated equipment.
  • All weighing and measurements must be documented.
3. Mix And Blend Raw Materials:
  • Raw materials must be mixed and blended thoroughly to ensure a homogeneous product.
  • Mixing and blending equipment must be cleaned and sanitized before use.
4. Chemical synthesis:
  • Chemical synthesis reactions must be carried out according to a written procedure.
  • All reactants and products must be carefully monitored and controlled.
5. Purification:
  • The API must be purified to meet the specified quality standards.
  • Purification methods must be validated to ensure that they are effective and consistent.
6. Crystallization:
  • The API may be crystallized to improve its purity and stability.
  • Crystallization conditions must be controlled to produce crystals of the desired size and morphology.
7. Drying:
  • The API must be dried to remove any residual solvents or moisture.
  • Drying conditions must be controlled to avoid degradation of the API.
8. Milling:
  • The API may be milled to reduce its particle size.
  • Milling must be carried out in a clean and controlled environment to avoid cross-contamination.
9. Packing And Labelling :
  • The API must be packed in suitable containers and labelled in accordance with all applicable regulations.
  • Packaging and labelling operations must be carried out in a clean and controlled environment.
10. Quality Control:
  • The API must be tested to ensure that it meets the specified quality standards.
  • Quality control tests must be performed by qualified personnel using calibrated equipment.
Records:

All records related to the manufacture of pharma APIs must be maintained and retained for a specified period of time in accordance with all applicable regulations.

Approvals:

This SOP must be approved by the QA Manager and the Production Manager.

Revisions:

This SOP will be reviewed and revised on an annual basis or as needed.