With over decades of experience, Dr. Reddy's specializes in developing and manufacturing High Potent Active Pharmaceutical Ingredients (HPAPI). We offer HPAPIs manufactured in our FDA inspected cGMP API manufacturing facilities with comprehensive containment processes (up to OEL 0.1µg/m³) and diligent QC/QA.

Dr. Reddy’s Approach in Handling HPAPIs

Our purpose "Good health can't wait" translates into three pillars with sustainability at the core

01
Step 1

Evaluating the hazard of exposure to a compound and calculating the OEL levels

02
Step 2

Selecting the appropriate containment strategy for development and manufacturing based on scale

03
Step 3

Choosing proper engineering controls such as ventilation, chemical contaminants, etc.

Dr. Reddy’s Approach in Handling HPAPIs

04
Step 1

Selecting the appropriate equipment and procedures, including PPE Sampling & weighing, blending, and drying

05
Step 2

Define Packaging needs to meet the requirements Capsule/Blistering Injectables

We are here to help, if you have any country specific requirements.

From initial stages of development to commercialization, our team of scientists, quality, regulatory, supply chain, and analytical experts work collaboratively to meet our global clients' HPAPI requirements.

As an integrated HPAPI supplier, we have best-in-class cGMP manufacturing facilities for APIs and finished dosage forms. With our integrated R&D capabilities and infrastructure, we are well-positioned to support our customers to bring their products to the market faster. In addition, our rigorous safety, health, and environmental (SHE) practices, together with Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls, are established to protect workers, materials, machines, and the environment.

Facilities for handling HPAPIs

Dr. Reddy’s can handle molecules of OEL up to 0.1 µg/m3 at the following facilities:

  • cGMP compliant isolator systems (OEL 0.1µg/m³) for high potent raw materials, intermediates charging, filtration and drying, dispensing and packaging
  • Reaction mass transfer through closed loop lines
  • Rapid transfer ports for solid material transfer
  • HVAC system with zone classification to avoid cross-contamination
  • EPA filtered air
  • Multiple utilities cooling tower water, hot water, chilled brine, nitrogen, compressed air & steam
  • Differential pressure system with temperature and humidity control
Step 1

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FAQs

What is Active pharmaceutical ingredient in Pharmaceutical Industry?
  • An active pharmaceutical ingredient is defined in ICH Q7 as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.”

What are the critical steps involved in manufacturing operations of API?
  • API manufacturers are expected to apply CGMPs to the API process beginning with the use of starting materials, and to validate critical process steps that impact the quality and purity of the final API. Controls over material quality are expected to increase as the process approaches the final API. The level of control needed is highly dependent on the manufacturing process and increases throughout the process as it proceeds from early intermediate steps to final isolation and purification steps. The appropriate level of control depends on the risk or criticality associated with each specific process step.
    An API process is a related series of operations which result in the preparation of an active pharmaceutical ingredient. Major operations or steps in an API process may include multi-step chemical synthesis and fermentation, purification, crystallization, drying, milling, packing, labelling, and testing. The final API the progresses towards appropriate characterization and analytical techniques.

What are the Regulations on APIs?
  • Each country will have its regulatory authority that continuously monitors the drug development process, licensing, registrations, marketing, and labelling of the products. Some of the notable regulatory bodies are as follows: USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), etc.
    The quality of APIs has a significant effect on the efficacy and the safety of medications. Poorly manufactured or adulterated APIs are associated with health issues, illness, or death. So, to ensure the quality and prevent the defects of APIs, regulatory bodies impose stringent rules & screen the APIs thoroughly to ensure medication quality as per the regulatory standards. Violating any of these regulatory standards or procedures can result in huge fines.

What is the current market growth for Pharmaceutical APIs ?
  • The global API market size is expected to reach USD 247.3 billion by 2025 from USD 185.3 billion in 2020, at a CAGR of 5.7%. Market growth will be steered by factors such as rising drug R&D, chronic diseases, the demand for generics, and the increasing uptake of biopharmaceuticals.

Disclaimer

No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.