Caplin Steriles Receives USFDA Approval for Phenylephrine Hydrochloride Ophthalmic Solution USP

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Caplin Steriles Receives USFDA Approval for Phenylephrine Hydrochloride Ophthalmic Solution USP

Team FS

24/May/2024

Key Points:

Caplin Steriles, a subsidiary of Caplin Point Laboratories, obtains final approval from the USFDA for Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10%.
The approved generic eye drops serve as a therapeutic equivalent to the Reference Listed Drug from Alcon Research LLC, indicated for pupil dilation.
With US sales of approximately $32 million, the approval opens new avenues for Caplin Steriles in the lucrative US pharmaceutical market.

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has achieved a significant milestone by securing final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10%—generic eye drops intended for pupil dilation. This approval underscores Caplin Steriles' commitment to delivering high-quality pharmaceutical solutions to meet critical healthcare needs.

Therapeutic Equivalent to Alcon's Reference Listed Drug
Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% serves as a therapeutic equivalent to the Reference Listed Drug (RLD) marketed by Alcon Research LLC. The approval paves the way for Caplin Steriles to offer an affordable alternative to the branded product, expanding access to essential eye care medication for patients in need.

Lucrative Market Potential
The USFDA approval of Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% comes at a time when the demand for generic pharmaceuticals is on the rise. With US sales of approximately $32 million for the 12-month period ending March 2024, according to IQVIA (IMS Health), the approval presents lucrative opportunities for Caplin Steriles to capture a significant share of the US ophthalmic pharmaceutical market.

Advancing Healthcare Access and Affordability
By introducing a generic therapeutic equivalent, Caplin Steriles aims to contribute to advancing healthcare access and affordability for patients in the United States. Generic medications offer comparable efficacy and safety profiles to branded counterparts at a fraction of the cost, ensuring that essential treatments are accessible to a broader population.

Conclusion: Driving Innovation in Pharmaceutical Sector
The USFDA approval of Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% reflects Caplin Steriles' commitment to driving innovation and excellence in the pharmaceutical sector. As the company prepares to launch its generic eye drops in the US market, it stands poised to make a meaningful impact on patient care while seizing opportunities for growth and expansion. Through strategic partnerships and a steadfast dedication to quality, Caplin Steriles continues to reinforce its position as a leading player in the global pharmaceutical landscape.

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Caplin Steriles Receives USFDA Approval for Phenylephrine Hydrochloride Ophthalmic Solution USP

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