The successful development of generic drugs goes far beyond merely meeting established quality standards. It requires robust and reliable manufacturing processes, well-understood impurity profiles, consistent product quality, comprehensive technical documentation, and comprehensive regulatory documentation support .

In complex pharmaceutical development programs, the quality attributes of the API, process robustness and supply reliability can directly influence the success of formulation development , regulatory submissions and commercial manufacturing. AkProva™ is the dedicated API portfolio of AKTINPHARM®, developed for generic drugs and established pharmaceutical products. Leveraging our three proprietary platforms — Phytopower^® Development Platform of Bioactive Molecules & Ingredients from Global Medicinal Plants, Aktinsyn^® Technology Platform of Synthetic Chemistry, and Aktinbio^® Development Platform of Biotechnology, we provide high-quality APIs and integrated technical support to global pharmaceutical enterprises, biotech companies and Marketing Authorization Holders (MAHs). Backed by rigorous process development, comprehensive quality research, and a registration-focused technical support system , we empower our clients through every stage—from pharmaceutical R&D and regulatory filing to commercial-scale production.

R&D Centers: Dedicated to the isolation, purification, and structural studies of natural active ingredients, process route exploration and technical evaluation, analytical method development and quality research, API & formulation CRO services, as well as active compound discovery and compound library construction—laying a solid research foundation for API development.
Non-GMP Facility: Focuses on process route exploration, route optimization, and non-GMP scaling-up, supplying high-quality samples for preclinical and R&D stages to meet the need for speed and flexibility in early-phase drug development.
GMP Facility: Powered by a comprehensive QC/QA quality management system to achieve commercial manufacturing of APIs and pharmaceutical intermediates , alongside full CRDMO services for both innovative and generic drugs.

The seamless synergy among our three dedicated sites forms a complete chain from R&D and process scale-up to commercial production, providing a strong foundation for the quality and reliability of the AkProva™ API portfolio.

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The AkProva™ Difference

Independent Process Development

We don't simply focus on making the molecule. AkProva™ combines synthetic chemistry expertise with systematic process route screening, development and optimization. By integrating synthetic route screening, critical step optimization, reaction condition studies, process parameter control, and scale-up feasibility assessments, we build active pharmaceutical ingredient (API) manufacturing processes designed around product quality, process robustness, production safety, scalability, and commercial viability.
From laboratory development through scale‑up and commercial manufacturing, we are committed to delivering transparent, reliable, and continuously optimized manufacturing solutions.

Quality Built Into the Process

Quality should not be tested only at the end; it must be built in through scientific understanding and process control. Our API development approach applies Quality by Design (QbD) principles. By studying Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), material attributes, impurities, and product stability, we establish a scientific and dependable quality control system. Our capabilities include:
• Process route screening and optimization
• Analytical method development and validation support

• Impurity identification and characterization
• Quality research

• Stability studies

• Process validation

• Process safety assessment

• Scale-up and commercial manufacturing support

Comprehensice Documentation

A high-quality API is only one part of successful drug registration. AkProva™ APIs are supported by the technical documentation required to help customers move efficiently from API evaluation to formulation development and regulatory submission.
Supported documentation includes:
• CMC technical dossiers 
• Analytical documentation
• Specifications and analytical methods
• Stability data
• Impurity studies
• Process descriptions and control strategies
• Process validation support documents
• DMF compilation and submission

Registration Support That Continues Beyond Supply

AkProva™ combines API development and manufacturing expertise with dedicated regulatory capabilities.
We work with pharmaceutical enterprises, CROs, and Marketing Authorization Holders (MAHs) to support regulatory submissions and ongoing product lifecycle requirements. Support can include:
• DMF compilation and submission
• ASMF/CEP registration support
• ANDA (Abbreviated New Drug Application) submission support 
• IND/CTA submission support
• NDA/MAA submission support
• Support for deficiency letters and regulatory inquiries
• Process change support
• Post-approval change applications
• Annual reports
• Re-registration support
• Product lifecycle management

AkProva™ — Supporting global development and commercialization of generic drugs and established pharmaceutical products with reliable processes, consistent quality, and comprehensive regulatory support.

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AkProva™ APIs

*Products protected under valid patents are not offered or supplied for commercial use.

This list does not attempt to set out in detail every variant of every product stocked. For comprehensive product listings and specifications, please click here for more information.

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Partner with AkProva™

Successful drug development relies on a dependable API supply chain and deep technical expertise. AkProva™ is dedicated to being your trusted API partner. With consistent product quality, robust process development capabilities, and an all-around technical support system, we help our clients accelerate formulation development, streamline regulatory filings, and achieve seamless commercial production.

Should you have inquiries regarding AkProva™ APIs or related CRDMO services, please feel free to get in touch with our team.

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Welcome to meet us: CPHI Milan 2026 from Oct. 6-8, Booth No.: 4H109