Caplin Point Laboratories Ltd. — Regulatory Filings 2026

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January 27, 2026

BSE Limited National Stock Exchange of India Ltd Department of Corporate Relationship Department of Corporate Services 1[st] Floor, New Trade Ring, Rotunda Building Exchange Plaza, 5[th] Floor, Phiroze Jeejeebhoy Towers C-1, Block G,Bandra Kurla Complex, Dalal Street, Mumbai- 400001 Bandra (E),Mumbai – 400 051 Scrip Code: 524742 Scrip Code: CAPLIPOINT .

Dear Sir/Madam,

Sub: Press Release – Receipt of USFDA approval for Methylprednisolone Acetate Injectable Suspension

Attaching herewith a Press Release regarding receipt of final approval by our Subsidiary, Caplin Steriles Limited, from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DEPO-MEDROL from Pfizer Inc., USA.

Request you to take the same on record.

Thanking You,

Sincerely Yours

For Caplin Point Laboratories Limited

VENKATRAM Digitally signed by VENKATRAM GANAPATHISUBRAMANIAN GANAPATHISUBRAMANIAN Date: 2026.01.27 15:05:39 +05'30'

Venkatram G General Counsel & Company Secretary Membership No. A23989

Encl: A/a

Press Release

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CAPLIN STERILES GETS USFDA APPROVAL FOR METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION

Chennai, January 27[th] , 2026: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration ( USFDA ) for its Abbreviated New Drug Application (ANDA) Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials , a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DEPO-MEDROL from Pfizer Inc., USA.

Methylprednisolone Acetate Injectable Suspension is primarily used as an anti-inflammatory treatment in various conditions, including in allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic diseases, ophthalmic diseases, respiratory diseases, rheumatic disorders etc. According to IQVIA[TM] (IMS Health), Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL & 80mg/mL Single Dose vials had US sales of approximately $57.4 million for the 12-month period ending November 2025.

About Caplin:

Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms. Caplin Point is one of the few companies to show consistent highquality growth in cash flows, Profitability and Revenues over the last 15 years. Caplin Point has appeared on Forbes “Asia’s 200 Best Under a Billion” list for an unprecedented 7[th] time in the last 10 years, and was awarded “The Emerging Company of 2018” and “Business Excellence Award for 2019” by Economic Times.

Caplin Steriles Limited (CSL), a Subsidiary of Caplin Point Laboratories Limited, is a fast growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. CSL has developed and filed 53 ANDAs in USA on its own and with partners, with 50 approvals (including acquired ANDA’s) so far. CSL is also working on a portfolio of 55+ simple and complex Injectable and Opthalmic products that it intends to file over the next 4 years. CSL also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, Saudi Arabia etc. Caplin One Labs Limited (COL), a Subsidiary of Caplin Point Laboratories Limited, is into the second year of its operations at its oncology unit in Kakkalur, with various ongoing projects in different stages of completion for generic and specialty products for both regulated and other markets. COL holds 5 approved ANDAs for Injectable and Opthalmic products.

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Press Release

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Cautionary Statement:

This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward-looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and Caplin Point has no obligation to update any such information or to correct any inaccuracies herein or omission here from which may become apparent.

For details, please contact:

Investor Relations at Caplin Registered Office Mr G Venkatram (General Counsel & Caplin Point Laboratories Limited Company Secretary) 3[rd] Floor, Ashvich Tower, No. 3, Developed Tel: +91 44 24968000 Plots Industrial Estate, Perungudi, Chennai – 600 096, Tamil Nadu, INDIA. [email protected] Tel: +91 44 2496 8000 CIN: L24231TN1990PLC019053 Churchgate Partners ISIN: INE475E01026 Anvita Raghuram / Rajiv Pandya NSE Code: CAPLIPOINT +91 22 6169 5988 BSE CODE: 524742 [email protected] Website: www.caplinpoint.net

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