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PRODUCT BOOKS

A fundamental duct system design manual for commercial and light industrial heating, ventilating and air conditioning systems. System effects for inlets and outlets of fans, noise control in ducts and use of extractors, splinters and dampers are included. New loss coefficients for elbows with 45-degree throats on square and radius heels and radius throats with square heels. Losses compare favorably with elbows with double wall turning vanes in several cases. Structured to offer the designer options in energy-efficient design methods, materials and construction. Includes soft metrics.

Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

An authoritative and practical guide to the art and science of formulating drugs.With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug , patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

An authoritative and practical guide to the art and science of formulating drugs.With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug , patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their and for generic companies to formulate drugs coming off patent

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

cGMP compliance
pre-approval inspections
stability and bioequivalence testing
packaging commodity development
common difficulties in formulating drugs

changes to aNDAs
Drug Delivery Nanoparticles Formulation and Characterization
Explore the fundamental concepts of drug delivery formulation and characterization.

Nanoparticulate Drug Systems II presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.

This Comprehensive Guide Features: 100 high quality images Process Analytical Techniques (PAT) used in manufacturing Nanoparticulate Drug Delivery Systems (NDDS) in-vitro and in-vivo evaluation of NDDS applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques.

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Second Edition

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses: candidate drug selection drug discovery and development preformulation predictions and drug selections design to commercial dosage form biopharmaceutical support in formulation development and more.

Pharmaceutical Suspensions: From Formulation Development to Manufacturing The suspension dosage form has long been used for poorly soluble ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is in the development of a suitable pharmaceutical suspension. The development of suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.

After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically detail the development of pharmaceutical suspensions, from pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to pharmaceutical filed is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists skilled in their specific areas. Contributing authors represent a cross-sections of scholars from Academic Institutions, Pharmaceutical Industries and Regulatory Agency.

Cell Therapy: cGMP Facilities and Manufacturing

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

Standard operating procedures
Supply management
Facility equipment
Product manufacturing, review, release and administration
Facility master file

Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement. The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.