Category: Approval/Launch Region: Asia Company: Aparna Pharmaceuticals

Aparna Group Gains US FDA Clearance for Pharma Entry

Aparna Group Gains US FDA Clearance for Pharma Entry

Aparna Group forays into pharma business vertical, receives US FDA clearance for Aparna Pharma manufacturing unit

Aparna Pharmaceuticals, a leader in manufacturing active pharmaceutical ingredients (APIs) and advanced drug intermediates, announced that its manufacturing facility, Aparna Organics Limited, located in Pydibhimavaram, Srikakulalam, Andhra Pradesh, India has received VAI classification from the United States Food and Drug Administration (FDA). The US FDA audited the facility during the month of September 2023.
 
This achievement underscores Aparna’s unwavering commitment to quality and compliance with global regulatory requirements. 
 

Executive’s words

Rakesh Reddy, managing director, Aparna Pharmaceuticals: “This clearance is a testament to our team’s relentless pursuit of excellence. Our facility’s compliance journey has been meticulous. We are thrilled to receive the US FDA’s stamp of approval. We are excited to contribute to global healthcare by delivering high quality pharmaceutical APIs and intermediates.”

Leader in API Manufacturing

With the successful completion of the FDA audit, Aparna Pharmaceuticals has emerged as a leading manufacturer of APIs and advanced drug intermediates and attained global recognition by providing high quality products manufactured as per cGMP guidelines. Driven by innovative R&D and optimum utilization of resources, the company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies.

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