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Osteotide Injection

NAFDAC Reg. No. A6-0497 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Osteotide Injection
NAFDAC number
A6-0497
Active ingredient
Teriparatide
Strength
750 mcg/3 mL
Form
Injection
Pack size
1 x 3 mL (in catridge)
Manufacturer
Not listed
Applicant (holder)
SJS Life Sciences Limited
Approved
28 Sep 2023
Status
Active View on NAFDAC ↗
Registration valid to
27 Sep 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Osteotide Injection is on the NAFDAC register with an active registration (A6-0497). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What Osteotide Injection is used for

From the official U.S. FDA label for teriparatide, the active ingredient registered with NAFDAC.

What it is used for

Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. …

Possible side effects

Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 )To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …

Do not use if

Teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.3 )]. Patients with hypersensitivity to teriparatide or to any of its excipients ( 4 )

Warnings

Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget’s disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.1 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary There are no available data on Teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing Teriparatide injection when pregnancy is recognized. …

Storage

Store Teriparatide injection under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Osteotide Injection

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Osteotide Injection

What is in Osteotide Injection?

Osteotide Injection contains Teriparatide (750 mcg/3 mL), as injection, according to its NAFDAC registration record.

Is Osteotide Injection registered with NAFDAC?

Yes. Osteotide Injection is listed on the NAFDAC register under registration number A6-0497, and its registration is active as of 5 November 2026.

Has Osteotide Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Osteotide Injection in our automatically synced alert list.

How can I check that my pack of Osteotide Injection is genuine?

Run a free authenticity scan with the NAFDAC number A6-0497, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Osteotide Injection used for?

Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and (Summarised from the official U.S. FDA label for teriparatide. Always follow your doctor or pharmacist.)

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