Caplin Steriles gets FDA EIR approval for Chennai unit: A boost for injectables

Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA). The approval is for its injectable and ophthalmic manufacturing unit located near Chennai, India. The US FDA inspection took place between May 22nd and May 31st, with the agency assigning a Voluntary Action Indicated (VAI) classification to the unit.

EIR Approval Marks Fourth Successful US FDA Audit for Caplin Steriles

C.C. Paarthipan, Chairman of Caplin Steriles, expressed satisfaction over the unit receiving the EIR after its fourth US FDA audit. “We’re pleased to receive the EIR with a satisfactory outcome,” said Paarthipan. “Our commitment to maintaining the highest levels of compliance at all our units remains steadfast. The EIR will help in receiving continued ANDA approvals for this unit, which is an important growth engine for us.”

Voluntary Action Indicated: What It Means for Caplin Steriles

The Voluntary Action Indicated (VAI) classification by the US FDA signifies that Caplin Steriles has successfully met compliance requirements. This classification is crucial for Caplin Steriles as it will enable the unit to continue receiving Abbreviated New Drug Applications (ANDA) approvals, fostering growth and expanding its product portfolio in injectable and ophthalmic solutions.

EIR Approval: A Milestone in Compliance and Future Growth

The receipt of the EIR from the US FDA is a significant milestone for Caplin Steriles and its parent company, Caplin Point Laboratories. The EIR approval reiterates the company’s commitment to adhering to international quality standards and will play a pivotal role in obtaining further ANDA approvals, thus functioning as a growth engine for the firm.

Caplin Steriles’ achievement in receiving the US FDA EIR approval is not just a compliance milestone but also a considerable advancement that stands to significantly influence its future growth and standing in the injectable and ophthalmic manufacturing sector.