Morepen Files Its First US ANDA for Sitagliptin, and the Stock Gains 2.5% as It Builds Beyond APIs
- September 28, 2026
- Posted by: Ankit Jaiswal
- Category: News
Morepen Labs Rs 123.37, up 2.48% (28 Sep, 1:50 PM). First US ANDA: Sitagliptin. CDMO deal Rs 825 crore. P/E 46.87 vs industry 38.42. ROE 5.96%.
Quick Answer
The Morepen Laboratories share price was Rs 123.37 at 1:50 PM on 28 September 2026, up 2.48 percent, after the company submitted its first Abbreviated New Drug Application to the US FDA for Sitagliptin tablets in 25 mg, 50 mg and 100 mg strengths. The filing extends Morepen from active ingredients and contract manufacturing into finished dosage forms and regulatory submissions. An ANDA filing is not an approval, and the FDA review can take many months. The stock trades at a P/E of 46.87 against an industry figure of 38.42, with a return on equity of only 5.96 percent.
Morepen Laboratories Limited said it has submitted its first ANDA to the US Food and Drug Administration, for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The company described the submission as an extension of its established API and CDMO expertise into integrated finished dosage development and regulatory filing.
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The Morepen Laboratories share price touched Rs 126.22 and traded on volume about 1.3 times its five-day average. This article looks at the filing, the CDMO order behind the recent rally and the risks for the Morepen Laboratories share price.
What the First ANDA Filing Means for Morepen
| Item | Detail |
|---|---|
| Filing | Abbreviated New Drug Application to the US FDA |
| Product | Sitagliptin Tablets USP |
| Strengths | 25 mg, 50 mg and 100 mg |
| Significance | First US ANDA for the company |
| Status | Submitted, not approved |
Morepen has long made active pharmaceutical ingredients and supplied other drug makers. Filing its own ANDA moves it up the value chain into finished tablets, which is the long-term story behind the Morepen Laboratories share price, where margins can be higher than in ingredients but competition and regulatory work are heavier.
A filing starts a review, and approval timelines are uncertain, so the news is a step in strategy rather than an earnings event for the Morepen Laboratories share price.
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Morepen Laboratories Share Price Today: Numbers and Technical Levels
| Metric | Value (28 Sep, 1:50 PM) |
|---|---|
| Morepen Laboratories share price | Rs 123.37 (up 2.48%) |
| Previous close | Rs 120.38 |
| Day range | Rs 119.45 to Rs 126.22 |
| Volume so far | 1.49 crore shares |
| Five-day average volume | 1.15 crore shares |
| RSI (14-day) | 54.6 |
| MACD vs signal line | 7.89 vs 8.85 |
| SuperTrend | Bullish, support at Rs 98.92 |
| 20-day average | Rs 116.21 |
| Market cap (Friday close) | Rs 6,600 crore |
| P/E vs industry P/E | 46.87 vs 38.42 |
The Morepen Laboratories share price is 6.2 percent above its 20-day average of Rs 116.21, and the RSI of 54.6 is neutral. The MACD line is just below its signal line, so momentum is flat, and the SuperTrend indicator shows support at Rs 98.92.
Volume of about 1.3 times the five-day average shows some interest in the Morepen Laboratories share price, though the stock has traded in a narrow Rs 116 to Rs 127 range over the past week.
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The CDMO Order Behind the Morepen Laboratories Share Price
In February 2026 Morepen won a multi-year CDMO mandate worth about Rs 825 crore, or USD 91 million, from a global pharma company, and the stock rose more than 15 percent that day. The company completed a first commercial dispatch of about Rs 50 crore in Q1 FY27.
It expects additional supplies of around Rs 225 crore in Q2 FY27, subject to customer schedules and regulatory and commercial requirements. The company has also reported a USFDA inspection at its Himachal API facility with zero observations, which supports its standing with global customers.
Valuation and Risks for the Morepen Laboratories Share Price
The stock trades at a P/E of 46.87 against an industry figure of 38.42, with a return on equity of 5.96 percent and a price to book of 5.30. Debt to equity is a low 0.17, but the valuation asks investors to pay for growth that has not yet appeared in returns.
Delivery is the first risk for the Morepen Laboratories share price, since the CDMO revenue depends on customer schedules. Regulatory outcomes are the second: an ANDA may face questions or delays, and any such delay would weigh on the Morepen Laboratories share price. The company must also show that new finished-dose work can earn returns above its current level of 5.96 percent on equity, since the market is already paying a premium multiple. Competition in generic sitagliptin is the third, and it could limit pricing.
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Conclusion
The Morepen Laboratories share price of Rs 123.37 reflects a small gain after its first US ANDA, a strategic step that is not yet an approval or a revenue source. The Rs 825 crore CDMO order and a low debt to equity of 0.17 are supports for the Morepen Laboratories share price, while a P/E of 46.87 with a return on equity of 5.96 percent leaves little cushion. Investors deciding whether to buy Morepen shares should watch the Rs 98.92 support, follow stop-loss levels and consult a SEBI-registered adviser.
Disclaimer: Data and figures in this article are sourced from publicly available information. These may or may not be accurate. Please verify all data independently before making any investment decision. Investments in securities are subject to market risk. This content is for educational purposes only and is not investment advice by Univest (SEBI RA INH000013776).
Frequently Asked Questions
What is the Morepen Laboratories share price today?
Ans. The Morepen Laboratories share price was Rs 123.37 at 1:50 PM on 28 September 2026, up 2.48 percent from Rs 120.38. The day high is Rs 126.22.
What ANDA has Morepen filed?
Ans. Morepen submitted its first ANDA to the US FDA for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths.
Does the ANDA filing mean approval?
Ans. No. It starts the FDA review, which can take many months, and approval is not assured.
How does the ANDA change the Morepen Laboratories share price outlook?
Ans. It signals a move into finished dosage forms, which could lift margins in future, but the Morepen Laboratories share price will depend on approval and launch timing.
What is Morepen’s CDMO deal?
Ans. In February 2026 the company won a multi-year CDMO mandate worth about Rs 825 crore from a global pharma company and began commercial dispatch in Q1 FY27.
What are the key technical levels for the Morepen Laboratories share price?
Ans. The key levels for the Morepen Laboratories share price are SuperTrend support at Rs 98.92 and the 20-day average of Rs 116.21. The RSI is 54.6.
Is the Morepen Laboratories share price expensive?
Ans. The P/E of 46.87 is above the industry figure of 38.42 and return on equity is 5.96 percent, so the valuation is at a premium.
Should I buy Morepen shares after the ANDA news?
Ans. The filing is a positive step but not an approval, and the valuation is high. Use a stop-loss and consult a SEBI-registered adviser.
