Pharma API Manufacturing Capabilities

Dr. Reddy’s Manufacturing Capabilities:

With an industry-leading portfolio of generic APIs and a proven track record in drug product development, we are among the earliest pharma API manufacturer with a vast portfolio of APIs and the preferred API partner of choice for pharma companies in more than 80+ countries. Our API manufacturing facilities are complemented by formulation facilities supplying various dosage forms.

Our business thrives on the deep technical strengths established over the last 30+ years in developing and manufacturing complex APIs such as steroids, peptides, complex long-chain molecules, and highly potent APIs. Dr. Reddy's successfully supplied APIs and finished dosage forms to various customers worldwide, and many customers have filed their dossiers and commercialized them in their respective countries.

Our API manufacturing facilities are operated in accordance with cGMP ICH Q7 guidance and are regularly inspected/audited by international regulatory authorities and numerous customers. We manufacture our APIs at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA, H`ealth Canada, etc.

We are multi-sourced on our KSMs for a sustainable supply; we have reliable KSM suppliers to ensure timely deliveries and adhere to stringent specifications. With additional capacity enhancement and API manufacturing facilities we are well-positioned to meet the global demands of essential APIs and future supply requirements.

Overview of Dr. Reddy’s API Manufacturing Facilities

Manufacturing Location

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Manufacturing Capabilities

170+ APIs
4,100+ KL of reactor volumes.
1250+ Reactors including ~100+ reactors with containment across 4 sites (HPAI /Oncology/ steroids/prostaglandins).
5,000+ MT of Intermediates manufactured.
90% of our API pipeline is forward integrated to generic formulations.
100+ Commercial Molecules
50+ Pipeline molecules (Filed + under development).
2,100+ MT of APIs manufactured.
Deep expertise in handing complex peptide molecules.
Can handle molecules of OEL up to 0.1 µg/m3 by protecting environment, people & product.

Quality Control

Quality Control Policies

A key component in quality control in pharmaceutical industry is helping customers by providing a quality product. We achieve this by ensuring that all our facilities operate efficiently and to the latest quality, safety, and productivity standards.

An integrated API quality control development approach and quality by design (QbD) principles have been adopted to develop a robust and scalable manufacturing process for consistent quality profile and effective process development with high-quality standards to meet regulatory requirements. By implementing current good manufacturing practices (CGMP) across our API manufacturing sites, we can produce high quality products and supply to our customers as per global requirements.

Quality Management

Dr. Reddy’s has continued to manufacture and deliver APIs following global regulations because of the processes and the analytical methods developed by our experts to avoid nitrosamine and azido impurities and follow stringent quality control of drugs and pharmaceuticals. We stay committed to ensuring that we continue to provide high-quality and safe APIs to our partners.

An extensive range of analytical techniques elucidate and demonstrate the chemical and physical attributes. All the potential and degradation impurities are thoroughly evaluated, identified, characterized, and controlled to meet the quality standards of the APIs as per the ICH guidelines.

Quality Assurance

The pharmaceutical quality assurance (QA) team at Dr. Reddy’s continually monitors various facets of the quality management system. We are committed to maintaining highest quality standards in cGMP manufacturing through periodic reviews and continuous improvement of quality management system. All our manufacturing units have undergone multiple cGMP audits by various regulatory authorities, and numerous quality audits by various customers. As a result, our high-quality APIs meets all the formulation needs for various global markets.

Review Meetings in terms of Quality control

With continuous monitoring through regular internal review meetings, cross functional audits, knowledge transfers, and harmonization of procedures across the organization. As a result, we are able to maintain and update our quality system. All our API manufacturing units are operated in accordance with cGMP regulations. Our customers recognize us for our proven regulatory track record including Drug Master File (DMF) or Chemistry, Manufacturing and Controls (CMC) section, Investigational New Drug Application (IND) and New Drug Application (NDA) filing, and deep experience with regulatory authorities such as the USFDA, WHO GMP, KFDA, PMDA, Health Canada, ANVISA and European Medicines Agency (EMA).