Composition: Proposed Metformin SR + Pioglitazone strengths; final label verification pending
Dosage form: Proposed sustained-release combination tablet
Usage: Type 2 diabetes mellitus
Category: Anti Diabetic Drugs
Therapeutic category: Biguanide + Thiazolidinedione
SKU: Metformin Pioglitazone SR Tablets
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Metformin Hydrochloride & Pioglitazone SR Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification to be verified)
Exporter: Healthy Inc (Star Export House status to be verified)
Metformin Hydrochloride & Pioglitazone SR Tablets are a proposed fixed-dose oral antidiabetic combination for adults with type 2 diabetes mellitus when both agents are clinically appropriate. Metformin reduces hepatic glucose production and improves insulin sensitivity, while pioglitazone improves insulin sensitivity through PPAR-gamma activation.
Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as exporter in the supplied description. Specific combination strengths, sustained-release characteristics, manufacturing methods, regulatory approvals and certification status require documentary confirmation.
| Product name | Metformin Hydrochloride & Pioglitazone SR Tablets |
|---|---|
| Proposed strengths (not confirmed by a composition label) | Metformin SR 500 mg + Pioglitazone 15 mg; Metformin SR 500 mg + Pioglitazone 30 mg; Metformin SR 1000 mg + Pioglitazone 15 mg |
| Dosage form | Proposed sustained-release combination tablet; final dosage form and release profile to be confirmed |
| Therapeutic class | Biguanide + thiazolidinedione (TZD) |
| Usage | Type 2 diabetes mellitus, where appropriate under the approved label |
| Pharmacopoeial standard | Applicable registered IP / BP / USP specifications to be confirmed |
| Packaging and shelf life | Subject to approved stability data and registered pack configuration |
| SKU | Metformin Pioglitazone SR Tablets |
Composition discrepancy: The supplied individual composition labels confirm metformin-only tablets (IP 500 mg and 1 g; BP 500 mg and 850 mg) and a different combination containing Metformin 500 mg + Glimepiride 1 mg. None confirms a Metformin + Pioglitazone finished-product composition. The three pioglitazone strengths above come from descriptive marketing text only.
A metformin sustained-release combination may use a polymer matrix or other validated release-control design. Bilayer compression, immediate-release pioglitazone, specific HPMC grades and 24-hour release cannot be asserted without approved formulation and batch records.
Manufacturing validation should address blend uniformity, drug content, dissolution/release performance, moisture exposure and packaging compatibility. All equipment and process claims should be checked against actual facility documentation.
Testing should follow approved specifications for identity, assay, content uniformity, dissolution or modified-release profile, related substances and stability. Acceptance limits and time points are formulation- and monograph-specific; claims such as universal 85% release in 30 minutes or 100% assay are not established by the supplied information.
Any WHO-GMP, impurity testing, certificate of analysis or market-registration claim should be supported by current documentation.
Metformin: decreases hepatic glucose production and improves peripheral insulin sensitivity. Pioglitazone: activates PPAR-gamma, improving insulin sensitivity in adipose and other tissues. The agents may provide complementary glycemic control in selected adults with type 2 diabetes.
Pioglitazone may cause fluid retention, weight gain and worsening heart failure; suitability requires individualized cardiovascular, renal, hepatic and fracture-risk assessment. The combination is not indicated for type 1 diabetes or diabetic ketoacidosis.
Registration requirements may include CTD/ACTD dossiers, validated analytical methods, stability data, product labeling and certificates of analysis. Availability of COPP, FSC, WHO-GMP certificates, export authorizations, and specific FOB/CIF terms must be confirmed with the manufacturer and exporter. Market-specific restrictions on pioglitazone should be reviewed before export.
Q: What strengths are confirmed?
A: No Metformin + Pioglitazone strength is confirmed by the supplied composition labels. The proposed 500/15 mg, 500/30 mg and 1000/15 mg combinations require verification.
Q: Are metformin-only and metformin/glimepiride tablets equivalent to this product?
A: No. These are distinct products with different active ingredients.
Q: Can pioglitazone cause swelling?
A: Yes. Fluid retention and edema may occur and can precipitate or worsen heart failure.
Q: Can an SR tablet be crushed?
A: Do not crush or chew modified-release tablets unless the approved label explicitly permits it.
Use only on a prescriber’s instructions and according to the locally approved combination-product label. The dose, frequency and titration depend on prior treatment, glycemic control, renal function and pioglitazone-related risks. Do not assume once-daily evening dosing for an unverified formulation. Swallow SR tablets whole unless the product labeling states otherwise.
Heart failure warning: Pioglitazone can cause or exacerbate congestive heart failure. Monitor for rapid weight gain, swelling and shortness of breath. Initiation in NYHA Class III or IV heart failure is contraindicated under certain major regulatory labels; follow local approved restrictions.
Other pioglitazone precautions: Edema, weight gain, fractures, liver concerns and possible bladder-cancer risk considerations; use in patients with active bladder cancer may be contraindicated or discouraged depending on local labeling. Metformin: Gastrointestinal upset, possible vitamin B12 reduction, and rare but serious lactic acidosis, especially with severe renal impairment or hypoxic illness. Check eGFR and other risk factors. Hypoglycemia is more likely when combined with insulin or insulin secretagogues. Review pregnancy and breastfeeding with a clinician.
Keep in the original packaging and protect from excess heat and moisture in accordance with the approved product label. The claimed below-25°C condition and 24-month shelf life require confirmation from registered stability studies. Keep out of reach of children.