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Company News Details

Morepen Laboratories Ltd

Industry : Pharmaceuticals - Indian - Bulk Drugs & Formln

BSE Code

ISIN Demat

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500288

INE083A01026

22.6801122

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P/E(TTM)

Mar.Cap( Cr.)

MOREPENLAB

62.27

6926.13

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2.03

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morepen laboratories ltd

Morepen Laboratories submits first ANDA to USFDA for Sitagliptin Tablets

Sep 28,2026

Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for Sitagliptin Tablets USP in 25 mg, 50 mg and 100 mg strengths. The submission extends the Company's established API and CDMO expertise into integrated finished dosage development and regulatory filing.

The Sitagliptin program brings together formulation development and scale-up, analytical method development and validation, impurity control, stability studies and manufacture of regulatory batches under GMP systems. It also incorporates bioequivalence strategy, coordination with contract research organizations and integration of development and study data into the regulatory dossier.

These capabilities strengthen Morepen's ability to support specialized CDMO assignments spanning API development, finished dosage formulation and regulatory submission, broadening the scope and complexity of customer programs it can undertake.

Morepen currently estimates 24–36 months from submission to progress towards approval and commercial supply, subject to FDA review, satisfactory completion of applicable formulation facility inspection requirements and applicable patent and exclusivity requirements.

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Sr No	Start Date	Department	Tender Details	Status	Download
1	28-09-2026		RFP for Manpower Agent
			A. Tender Document
			B. GeM Bidding Document
2	26-09-2026		Procurement of i7-13700 or Higher Latest Processor-Based Tower Desktops
2	28-06-2026		RFP for New Office Premises at Bangalore
			A. General Information
			B. Technical BID
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			D. Technical BID Meeting Link
3	13-02-2026	Admin	RFP for Housekeeping and Security Guard	Closed
	10-03-2026		A. Financial BID Meeting Link
			Cancellation notice for RFP
4	31-01-2026	IT & IT Back Office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Closed
			Schedule of Pre-Bid Meeting - RFP No. IFIN/IAAP/2025-26/002
	17-02-2026		Extension of – RFP No.: IFIN/IAAP/2025-26/002
	19-02-2026		Number of Pages - RFP No.: IFIN/IAAP/2025-26/002
	26-02-2026		Opening of Technical Bid - RFP No IFIN_IAAP_2025_26 002
	02-03-2026		Opening of Financial Bid - RFP No IFIN_IAAP_2025_26 002
	16-03-2026		Intimation of Award - RFP No. IFIN/IAAP/2025-26/002
5	28-01-2026	IT	RFP for Procurement of Sophos Firewall	Closed
			A. General Information
			B. Technical BID
			C. Financial BID
			D. Pre BID Meeting Link
			E. Technical BID Meeting Link
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6	01-01-2026	IA	RFP for Appointment of Internal Auditors for Period April 2026 – March 2027	Open
7	01-01-2026	IA	RFP for Appointment of Concurrent Internal Auditors for Period April 2026 – March 2027	Open
8	27-11-2025	IT & IT Back office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Cancelled
	27-01-2026	IT & IT Back office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Cancelled
			A. Schedule of Pre-Bid Meeting - RFP No. IFIN/IAAP/2025-26/001
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9	30-10-2025		RFP for Vehicle Hiring
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10	02-09-2025	IT	RFP for Procurement of Server	Closed
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11	21-08-2025	IT	RFP for Procurement of Server	Closed
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12	14-07-2025		RFP document for the Cloud Voice Logger	Closed
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13	01-04-2025	IA	REQUEST FOR PROPOSAL FOR APPOINTMENT OF CONCURRENT INTERNAL AUDITORS FOR PERIOD APRIL 2025 – MARCH 2026
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15	24-04-2025	IT	RFP for Services of IT Infrastructure Shifting & Configuration	Closed
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16	18-02-2025	IT	RFP for Procurement of HP Hard Disk	Closed
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17	18-02-2025	IT	RFP for Procurement of HP Server	Closed
			A. General Information
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18	07-12-2024	Administration	RFP for office premises on lease at Chennai	Closed
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			D. Financial Bid
			E. Pre Bid Meeting Link
			F. Technical BID Meeting Link
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19	10-06-2024	IA	RFP for appointment of internal auditors for period April 2024 – March 2025	Active upto 21/06/2024 end of the day
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20	10-06-2024	IA	RFP for appointment of internal auditors and Concurrent Audit for period April 2024 – March 2025	Active upto 21/06/2024 end of the day
21	22-11-2023	Compliance	Procurement of AML/PML software Solution - VC Meeting Link for opening of Tender Box on 22/11/2023 at 4.30 pm	Closed
22	16-10-2023	Compliance	RFP for Procurement of AML/PML software solution
	06-11-2023	Compliance	A. Addendum - Extension Period for procurement of AML/PML sofware solution
23	28-10-2024	IT	RFP for Procurement of Firewall	Closed
			A. General Information
			B. Technical Bid
			C. Financial Bid
24	12-07-2023	ADMIN	RFP for Premises on Lease for Ahmedabad Branch
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25	07-07-2023	CS	RFP for Secretarial Audit
26	26-06-2023	IT	RFP for AMC of Online UPS system installed at IFINs Branch office	Closed
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			B. Technical Bid
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27	16-06-2023	IT	E-tender for engagement of annual system audit and cyber security audit agency	Closed
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			B. Technical Bid
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28	15-06-2023	IT	RFP for AMC of 30KVA Online UPS system	Closed
			A. General Information
			B. Technical Bid
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29	30-05-2023	ADMIN	RFP for Premises on Lease for Ahmedabad Branch	Cancelled
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			B. General Information
			C. Technical Bid
			D. Financial Bid		Download RFP for Premises on Lease for Ahmedabad Branch - Financial Bid PDF
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30	24-05-2023	ADMIN	RFP for Premises on Lease for Salem Branch	Closed
			A. Newspaper Aricle
			B. General Information
			C. Technical Bid
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31	24-04-2023	IA	Extension Of RFP iCOM IA for FY 2023-2024	Closed
32	25-04-2023	CS	Extension Of RFP for Seeking Quotations for Secretarial Audit Of IFIN Group for FY 2022-2023	Cancelled
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33	02-05-2023	IA	RFP For Appointment Of Internal Auditor for July 2023 - March 2024	Closed
34	02-05-2023	IA	RFP For Appointment Of Internal Auditor for July 2023 - March 2024 for operations, accounts and control related activities.	Closed
35	24-04-2023	CS	RFP PCS Empannelment for ROC filing 2022-23	Closed
36	24-04-2023	IA	RFP For Appointment Of Internal Auditor iCOM 23-24	Closed
37	14-03-2023	IA	RFP for appointment of internal auditor in the iCOM	Closed
38	25-04-2023	CS	RFP For Secretarial Audit 22-23	Closed

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