Neuland Labs Company Profile: Products, Promoters and Clients

Question 1: What are the products and services of Neuland Labs?

Neuland Laboratories (NLL), founded in 1984, is a leading pharmaceutical company based in India. In April 1992, NLL merged with Neuland Drugs & Pharmaceuticals Pvt Ltd, another company started by the same founders for bulk drug production. The company focuses on producing several bulk drugs, such as salbutamol sulfate, terbutaline sulfate, labetalol hydrochloride, and ciprofloxacin. Their products and services can be broadly categorized as follows:

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1- Active Pharmaceutical Ingredients (APIs)

• Custom API Manufacturing: Neuland Labs makes APIs for many health areas, such as heart health, the central nervous system, infections, asthma, diabetes, and digestive issues. They offer a wide range of APIs for both generic and branded drug companies.
• Specialty APIs: The company also produces complex APIs that require advanced processes like chiral synthesis, multi-step synthesis, and peptide chemistry. These APIs are used in specialized treatments and need high-level manufacturing skills.
• Regulatory-Compliant APIs: Neuland Labs follows strict rules from global health authorities like the US FDA and the European Medicines Agency. Their facilities are regularly checked to meet current Good Manufacturing Practices (cGMP).

2- Contract Development and Manufacturing Organization (CDMO) Services

• Custom Chemical Synthesis: The company provides contract manufacturing for custom synthesis projects. They help pharmaceutical companies create new chemical entities (NCEs) from early development to total production. Neuland collaborates with clients to develop specific solutions for complex chemical synthesis needs.
• Process Development and Optimization: As a CDMO, Neuland helps improve chemical processes to increase yield, lower costs, and ensure scalability. They use advanced analytical methods and chemical engineering to enhance manufacturing for small and large-scale production.
• Peptide Synthesis: Neuland Labs specializes in peptide synthesis, creating complex peptides for pharmaceuticals. They use solution-phase and solid-phase techniques to meet the different needs of peptide-based drugs.
• Analytical Services: They offer analytical services to support drug development, including method development, validation, stability studies, and impurity profiling. It ensures that their products meet quality standards and regulatory requirements.

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3- Custom API Development (CRAMS)

• Custom Research and Manufacturing Services (CRAMS): The company works with pharmaceutical companies to create custom active pharmaceutical ingredients (APIs). They handle everything from early research to large-scale production of specialized APIs.
• Early-Stage and Late-Stage Development: Neuland Labs supports API development during clinical trials and assists in moving projects from research to production. They also help manage existing products by reformulating and improving them.

4- Complex Generics Development

• Niche API Production for Generic Drugs: Neuland specializes in making complex APIs that are hard to produce for generic drugs. This includes high-potency active pharmaceutical ingredients (HPAPIs), controlled substances, and medicines that need multiple steps to make.
• Generic Drug Substance Development: The company helps develop and produce generic drug substances, the main active ingredients in generic medications. This support is for generic pharmaceutical companies seeking affordable alternatives to branded drugs.

5- Regulatory Support and Documentation

• Regulatory Submissions and Compliance: The company helps with regulatory filings, such as Drug Master Files (DMFs) and Certificates of Suitability (CEPs). Their team ensures that all APIs meet global standards for easy market entry for pharmaceutical companies.
• Auditing and Quality Assurance: Global regulatory bodies regularly inspect Neuland Labs' facilities to ensure high-quality API production. Their quality assurance team performs internal audits and follows current Good Manufacturing Practices (cGMP).

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6- Specialized Capabilities

• High-Potency API (HPAPI) Manufacturing: Neuland makes high-potency APIs for cancer treatments. They have special facilities to produce and handle these substances safely.
• Peptide and Complex Molecule Synthesis: Neuland's facilities are equipped to synthesize peptides and complex molecules, needing advanced technology and chemistry expertise.

7- Supply Chain and Logistics Services

• Global Supply Chain Management: The company has built a robust supply chain that delivers APIs on time worldwide. Following international pharmaceutical standards, the company handles all logistics, including inventory, packaging, and transportation.
• Packaging and Labeling: Neuland Labs provides packaging solutions that meet market regulations, ensuring the safe delivery of APIs to clients.

Question 2: Who are the promoters of Neuland Labs Company?

The promoters of Neuland Labs are Davuluri Rama Mohan Rao, Davuluri Vijaya Rao, Davuluri Sucheth Rao, Davuluri Saharsh Rao, Davuluri Rohini Niveditha Rao, Gannabathula Venkata Krishna Rama Rao, Gannabathula Veeravenkata Satyanarayanamurty, Gannabathula Uma Bala, Usha Rani Reddy Chevalla, Velugubanti S Prasadarao and Suryanarayana M Siram.

Sucheth Davuluri is CEO of the company. Saharsh Davuluri Vice-Chairman and Managing Director of Neuland Labs.

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